Anti-inflammatory Medicines – Drug Online https://edrug-online.com Medication Information Guide Sun, 22 Nov 2020 09:39:08 +0000 en-US hourly 1 https://wordpress.org/?v=5.7.1 Betnesol Uses, Dosage, Side Effects, Precautions & Warnings https://edrug-online.com/1729/betnesol-injection.html https://edrug-online.com/1729/betnesol-injection.html#respond Sun, 22 Nov 2020 09:39:08 +0000 https://edrug-online.com/?p=1729 why betnesol injection during pregnancybetnesol injection >> Generic drug of the Therapeutic class: Anti-inflammatory active ingredients: Betamethasone what is betnesol injection ? This medication is a corticosteroid. what is betnesol injection used for and indication? It is indicated in certain diseases, where it is used for its anti-inflammatory effect. It can be used in local injection, in dermatology, in ophthalmology, in ENT, […]]]> why betnesol injection during pregnancy

betnesol injection >> Generic drug of the Therapeutic class: Anti-inflammatory
active ingredients: Betamethasone

what is betnesol injection ?

This medication is a corticosteroid.

what is betnesol injection used for and indication?

It is indicated in certain diseases, where it is used for its anti-inflammatory effect.

It can be used in local injection, in dermatology, in ophthalmology, in ENT, and in rheumatology.

PRESENTATION (S) AVAILABLE FOR BETNESOL 4 MG / 1 ML

1 glass vial (s) of 1 ml

FEATURE DESCRIPTION
Pharmaceutical class systemic corticosteroids
Active substance (s) for a 1.0 ml ampoule: betamethasone (phosphate) and disodium (5.3 mg)
General medicine no
Pharmaceutical form injectable solution
Route (s) of administration endosinus, intra-articular, intralesional, intramuscular, intravenous, periarticular, periocular, parenteral other
Social security reimbursement rate 65%
Laboratory (s) SIGMA-TAU FRANCE
Conditions of issue available by simple prescription

Betnesol Dosage

  • Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
  • The dose to use is determined by your doctor, depending on your weight and the disease being treated.
  • It is strictly individual.

Betnesol Contraindications

Do not take BETNESOL 4 mg / 1 ml, solution for injection in the following cases:

  • most infections,
  • certain evolving viral diseases (viral hepatitis, herpes, chickenpox, shingles),
  • certain untreated mental disorders,
  • vaccination with live vaccines,
  • allergy to one of the constituents,
  • coagulation disorders, current anticoagulant treatment in case of intramuscular injection.

This medication SHOULD NOT GENERALLY BE USED, unless your doctor advises otherwise, in combination with sultopride and live attenuated vaccines.

LOCAL USE

This medication MUST NOT BE USED in the following cases:

  • infections,
  • allergy to one of the constituents,
  • coagulation disorders, anticoagulant therapy in progress.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST

How To Take Betnesol ?

Method and route of administration

  • INTRAVENOUS, INTRAMUSCULAR, LOCAL INJECTABLE ROUTE

Duration of treatment

  • It is determined by your doctor

how does Betnesol work?

Pharmacotherapeutic group: Glucocorticoids, ATC code: H02AB01 (H: Systemic non-sex hormones).

  • Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones. Synthetic corticosteroids, including betamethasone, are used primarily for their anti-inflammatory effect.
  • In high doses, they decrease the immune response. Their metabolic and sodium retention effect is less than that of hydrocortisone.

How To Store Betnesol ?

  • Keep this medication out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month.
  • After opening, the product should be used immediately.
  • Store at a temperature below 30 ° C and protected from light.
  • Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

What are the side effects of Betnesol?

Like all medicines, BETNESOL 4 mg / 1 ml, solution for injection can cause side effects, although not everybody gets them.

Due to the presence of sodium metabisulfite (E223), risk of allergic reactions, including generalized allergic reaction with respiratory discomfort.

INTRAVENOUS OR INTRAMUSCULAR USE

This essential medication is usually well tolerated when the recommendations given by your doctor are followed.

However, depending on the dose and duration of treatment, it can cause more or less bothersome effects. The most frequently encountered are:

  • swelling and redness of the face, weight gain
  • appearance of bruises
  • increased blood pressure
  • excitement and sleep disturbances
  • bone fragility
  • modification of certain biological parameters (salt, sugar, potassium), which may require a diet or additional treatment.

Other much rarer effects have been observed:

  • risk of insufficient secretion of the adrenal gland
  • growth disorder in children
  • period disorders
  • muscle weakness
  • hiccups, ulcers and other digestive problems
  • skin disorders
  • certain forms of glaucoma (increased pressure inside the eye) and cataracts (clouding of the lens).

Certain effects linked to intravenous administration have been described: allergic manifestations.

LOCAL USE

  • local risks: infection, lesion, inflammation and calcifications of the joint,
  • a few cases of tendon ruptures have been described exceptionally, in particular in co-prescription with fluoroquinolones,
  • repeated injections may cause symptoms of hypercorticism (weight gain, swelling, hypertension) and unbalance diabetes, high blood pressure,
  • headaches and hot flashes can occur. They usually go away within a day or two,
  • weakening of the skin,
  • local and general allergic reactions.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Betnesol Interactions

SYSTEMIC USE

Not recommended associations

 Sultopride

  • Increased risk of ventricular rhythm disturbances, in particular torsades de pointes.

Live attenuated vaccines

  • Risk of generalized, possibly fatal disease. This risk is increased in subjects already immunocompromised by the underlying disease.
  • Use an inactivated vaccine when it exists (poliomyelitis).

Combinations subject to precautions for use

 Acetylsalicylic acid by system (and, by extrapolation, other salicylates) 

  • Decrease in salicylemia during treatment with corticosteroids and risk of salicylate overdose after stopping it (increased elimination of salicylates by corticosteroids).
  • Adjust the doses of salicylates during the combination and after stopping treatment with corticosteroids.

Medicines liable to give torsades de pointes (except sultopride)

  • Correct any hypokalaemia before administering the product and perform clinical and electrocardiographic monitoring. Increased risk of ventricular rhythm disturbances, in particular torsades de pointes.

Oral anticoagulants

  • Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and on that of coagulation factors. Haemorrhagic risk specific to corticosteroid therapy (digestive mucosa, vascular fragility) at high doses or in prolonged treatment longer than 10 days.
  • When the association is justified, strengthen monitoring: biological control on the 8th day, then every 15 days during corticosteroid therapy and after stopping it.

Other hypokalaemic drugs 

  • Increased risk of hypokalaemia (additive effect).
  • Monitoring of serum potassium with, if necessary, correction to be taken into account in particular in case of digitalis therapy.

Digital 

  • Hypokalaemia promoting the toxic effects of digitalis.
  • Correct any hypokalaemia beforehand and perform clinical, electrolyte and electrocardiographic monitoring.

Heparin (parenteral route) 

  • Aggravation by heparin of the hemorrhagic risk specific to corticosteroid therapy (digestive mucosa, vascular fragility) at high doses or in prolonged treatment longer than 10 days.
  • The association must be justified, strengthen surveillance.

Anticonvulsants Enzyme inducers 

  • Decrease in plasma concentrations and the efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important in Addisonians and in cases of transplantation.
  • Clinical and biological monitoring, adjustment of the dosage of corticosteroids during treatment with the inducer and after its discontinuation.

Insulin, metformin, sulfonylureas 

  • Elevation of blood sugar with sometimes ketoacidosis (decrease in tolerance to carbohydrates by corticosteroids).
  • Warn the patient and reinforce blood glucose self-monitoring, especially at the start of treatment. If necessary, adjust the dosage of the antidiabetic medication during treatment with corticosteroids and after stopping it.

Isoniazid (described for prednisolone)

  • Decreased plasma concentrations of isoniazid. Mechanism invoked: increased hepatic metabolism of isoniazid and decrease in that of glucocorticoids.
  • Clinical and biological monitoring.
  • The effect of corticosteroids may be increased by ritonavir and ketoconazole.
  • It may be necessary to change, or generally decrease, the dose of anticoagulants given simultaneously.

Associations to take into account

Antihypertensive drugs, except beta-blockers 

  • Decreased antihypertensive effect (hydrosodium retention of corticosteroids).

 Interferon alfa 

  • Risk of inhibition of the action of interferon.

Non-depolarizing curares 

  • Risk of severe myopathy, reversible after a possibly long delay (several months).

Fluoroquinolones

  • Possible increased risk of tendinopathy, or even tendon rupture (exceptional), particularly in patients receiving prolonged corticosteroid therapy.

LOCAL USE

  • The risks of interactions of glucocorticoids with other drugs are exceptional by local injection under the usual circumstances of use. These risks should be considered in the event of multiple injections (several locations) or repeated in the short term.
  • In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Effects on ability to Drive and use machines

Warnings and Precautions

Special warnings

This medicine should be taken under strict medical supervision.

INTRAVENOUS OR INTRAMUSCULAR USE

BEFORE TREATMENT

  • Tell your doctor in the event of recent vaccination, in the event of digestive ulcer, diseases of the colon, recent surgery on the intestine, diabetes, high blood pressure, infection (especially history of tuberculosis) , liver failure, kidney failure, osteoporosis and myasthenia gravis (muscle disease with muscle fatigue).
  • Tell your doctor if you are staying in tropical, subtropical or southern Europe, due to the risk of parasitic disease.
  • Oral or injectable corticosteroids can promote the appearance of tendinopathy, or even tendon rupture (exceptional). Tell your doctor if you have tendon pain.

AFTER TREATMENT

  • Avoid contact with people with chickenpox or measles.

LOCAL USE

  • In the absence of data concerning the risk of calcification, it is preferable to avoid the administration of a corticosteroid intra-disc.
  • Notify your doctor in the event of recent vaccination and evolving viral diseases (viral hepatitis, herpes, chickenpox, shingles).
  • This medicine should be taken under strict medical supervision.
  • Tell your doctor if pain or fever develops after the injection.
  • Repeated injections may cause symptoms of hypercorticism (weight gain, swelling, hypertension, etc.) and cause diabetes, mental disorders or severe hypertension to become unbalanced.
  • IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Precautions for use

  • This medicinal product contains 3.32 mg of sodium per ampoule: take this into account in people on a low-salt, strict diet.
  • Your doctor may advise you to follow a diet, especially low in salt.
  • IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

betnesol in pregnancy & BREAST-FEEDING & FERTILITY

Pregnancy

Systemic use:

  • In animals, experimentation shows a variable teratogenic effect depending on the species.
  • In humans, there is a placental transfer. However, epidemiological studies have not detected any risk of malformation associated with taking corticosteroids during the first trimester.
  • Early studies in animals showed an increase in fetal palate division after maternal ingestion of high doses of corticosteroids.
  • A review of the safety data for systemic corticosteroids used during pregnancy and lactation, conducted by the Committee on Safe Medication, concluded that there is no convincing evidence that corticosteroids cause an increased incidence of steroids. congenital anomaly. Prolonged or repeated use during pregnancy actually increases the risk of intrauterine growth retardation but it does not appear to be a risk after short-term treatment. It has also been noted that corticosteroids vary in their ability to cross the placental barrier; betamethasone and dexamethasone immediately cross the placenta, while 88% of prednisolone is inactivated when it crosses the placenta.
  • In chronic diseases requiring treatment throughout pregnancy, a slight delay in intrauterine growth is possible. Neonatal adrenal insufficiency has been observed exceptionally after high dose corticosteroid therapy.
  • It is justified to observe a period of clinical (weight, diuresis) and biological monitoring of the newborn.
  • Therefore, corticosteroids can be prescribed during pregnancy if needed.

Local use:

  • The risk of systemic corticosteroids should be considered in the event of multiple injections (several locations) or repeated short-term: with systemic corticosteroids a slight delay in intrauterine growth is possible. Neonatal adrenal insufficiency has been observed exceptionally after high dose corticosteroid therapy.

Feeding with milk

Systemic use:

  • In case of treatment in large doses and chronically, breast-feeding is not recommended.

Local use:

  • In case of treatment in large doses, breast-feeding is not recommended

What happens if I overdose from Betnesol ?

Overdose of glucocorticoids, including betamethasone, is not life-threatening. With the exception of extremely high doses, an overdose of corticosteroids for a few days is not likely to induce a dangerous condition, in the absence of specific contraindications, such as diabetes, glaucoma, or active gastric ulcer, or in the absence of concomitant treatment with digitalis, coumarin or diuretics which induce potassium depletion.

What should I do if I miss a dose?

  • Not applicable.
  • Not applicable.
  • Not applicable.
  • Not applicable.

What happens if you stop taking Betnesol ?

  • Not applicable.
  • Not applicable.
  • Not applicable.
  • Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is  Forms and Composition ?

SHAPES and PRESENTATIONS

  • Solution for injection:   1 ml break-free ampoules-bottles, box of 3.

COMPOSITION

Active substance

Betamethasone disodium phosphate: 5.3 mg

Corresponding amount of betamethasone: 4.0 mg

For a 1 ml ampoule.

The content of sodium metabisulfite expressed as SO2 is 0.67 mg per ampoule

Other components

Sodium chloride, phenol, sodium edetate, sodium metabisulphite (E223), officinal sodium hydroxide solution, water for injections.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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celestamine Uses, Dosage, Side Effects, Precautions & Warnings https://edrug-online.com/1739/celestamine.html https://edrug-online.com/1739/celestamine.html#respond Sun, 22 Nov 2020 09:39:01 +0000 https://edrug-online.com/?p=1739 celestamine tablet imageGeneric drug of the therapeutic class: Anti-inflammatory active ingredients: Betamethasone , Dexchlorpheniramine what is celestamine ? This medication contains a corticosteroid, betamethasone and an antihistamine, dexchlorphenamine. What is the use of Celestamine and indication? It is indicated in adults and children over 6 years of age for symptomatic treatment: seasonal or perennial allergic rhinitis after failure of an antihistamine alone or […]]]> celestamine tablet image

Generic drug of the therapeutic class: Anti-inflammatory
active ingredients: Betamethasone , Dexchlorpheniramine

what is celestamine ?

This medication contains a corticosteroid, betamethasone and an antihistamine, dexchlorphenamine.

What is the use of Celestamine and indication?

It is indicated in adults and children over 6 years of age for symptomatic treatment:

  • seasonal or perennial allergic rhinitis after failure of an antihistamine alone or combined with local corticosteroid therapy,
  • acute urticaria.

PRESENTATION (S) AVAILABLE FOR CELESTAMINE

1 polypropylene bottle (s) of 30 tablet (s)

FEATURE DESCRIPTION
Pharmaceutical class not communicated
Active substance (s) for one tablet: betamethasone (0.250 mg), dexchlorpheniramine maleate (2,000 mg)
General medicine no
Pharmaceutical form compressed
Route (s) of administration oral
Selling price unregulated price
Social security reimbursement rate 0%
Laboratory (s) Laboratory (s) manufacturer Celestamine
Conditions of issue available by simple prescription

how often celestamine (Dosage)?

As an indication, the usually effective dosage is:

  • Adult and child over 12 years old : 3 or 4 tablets per day.
  • Child from 6 to 12 years old : 1 tablet, morning and evening.
  • The minimum effective dosage should always be sought, which can be lowered to 1 tablet every 2 days.
  • The usual duration of treatment for acute urticaria will not exceed 10 days; also stopping treatment does not require a decrease.

celestamine Contraindications

Never take CELESTAMINE, tablet in the following cases:

  • child under 6 years old (due to the risk of aspiration due to the tablet form).
  • known allergy to the constituents of the product and in particular to corticosteroids and antihistamines.
  • infections, certain evolving viral diseases (viral hepatitis, herpes, chickenpox, shingles),
  • vaccination with live vaccines.
  • certain untreated mental disorders,
  • difficulty urinating from prostate or other causes,
  • some forms of glaucoma (increased pressure inside the eye).

This medication is GENERALLY NOT RECOMMENDED, unless your doctor advises otherwise:

  • in case of breastfeeding;
  • combination with drugs which may cause certain heart rhythm disturbances.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

How To Take celestamine ?

Method and route of administration

  • ORAL
  • The tablets are to be swallowed with a glass of water, preferably at the end of a meal.

Duration of treatment

  • Observe the duration prescribed by your doctor.

how does celestamine work?

Pharmacotherapeutic group: Combination of a GLUCORCORTICOID FOR SYSTEMIC USE and an ANTIHISTAMINIC FOR SYSTEMIC USE (D. Dermatology) (R. Respiratory system), ATC code: R06AB52.

Betamethasone: synthetic corticosteroid used primarily for its anti-inflammatory effect.

Dexchlorphenamine: antihistamine H1, with a propylamine structure (substituted alkylamine), which is characterized by:

  • A sedative effect marked at usual doses , of histaminergic origin and central adrenergic blocking agent,
  • Anticholinergic effect causing peripheral side effects ,
  •  An adrenergic blocking effect device, which can resound in hemodynamically (risk of orthostatic hypotension).

Antihistamines have in common the property of opposing , by more or less reversible competitive antagonism, the effects of histamine, in particular on the skin, the vessels and the conjunctival, nasal, bronchial and intestinal mucous membranes.

How To Store celestamine ?

  • Keep this medication out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date refers to the last day of that month.
  • Store at a temperature not exceeding 25 ° C.
  • Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

What are the side effects of Celestamine?

Like all medicines, CELESTAMINE, tablet can cause side effects, although not everybody gets them.

  • Certain side effects require IMMEDIATELY STOPPING TREATMENT AND TELL A DOCTOR:
    • Allergic reactions:
      • rash type (erythema, eczema, purpura, urticaria);
      • angioedema (urticaria with sudden swelling of the face and neck which may cause difficulty in breathing);
      • anaphylactic shock;
  • Significant drop in white blood cells in the blood which may manifest as the onset or resurgence of a fever with or without signs of infections;
  • Abnormal decrease in platelets in the blood which may result in bleeding from the nose or gums.
  • Other side effects may occur:
  • Drowsiness, decreased vigilance,
  • Dry mouth, visual disturbances, urine retention, constipation, palpitations, change in blood pressure,
  • Memory or concentration problems, dizziness (more common in the elderly),
  • Excitement, motor incoordination, tremors,
  • Confusion, hallucinations,
  • Swelling and redness of the face, weight gain.
  • Appearance of bruises,
  • Bone fragility,
  • Modification of certain biological parameters (salt, sugar, potassium), which may require a diet or additional treatment.
  • Other side effects, much rarer, have been observed:
  • Risk of insufficient secretion of the adrenal gland,
  • Growth disorder in children,
  • Menstruation disorders,
  • Weak muscles.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

celestamine Interactions

Not recommended associations

Linked to the presence of betamethasone :

Medicines giving torsades de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentaminide, sparfloxacin, sultopride, terfenadine, vincamine):

  • Use substances which do not have the disadvantage of causing torsades de pointes in the event of hypokalaemia.

CYP3A inhibitors

  • Co-administration of CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side effects. The combination should be avoided unless the benefits outweigh the increased risk of systemic side effects from corticosteroids; in this case, patients should be monitored for possible systemic side effects of corticosteroids.

Related to the presence of dexchlorphenamine :

Alcohol:

  • Alcohol enhancement of the sedative effect of the antihistamine H1. Impaired vigilance can make driving and using machines dangerous.
  • Avoid taking alcoholic drinks and other drugs containing alcohol.

Combinations subject to precautions for use

Linked to the presence of betamethasone :

Acetylsalicylic acid by system and by extrapolation from other salicylates

  • Decrease in salicylemia during treatment with corticosteroids and risk of salicylate overdose after stopping it, by increased elimination of salicylates by corticosteroids.
  • Adjust the doses of salicylates during the combination and after stopping treatment with corticosteroids.

Antiarrhythmics giving torsades de pointes (amiodarone, brétylium, disopyramide, quinidines, sotalol):

  • Hypokalaemia is a contributing factor as is bradycardia and a pre-existing long QT space.
  • Prevent hypokalaemia, correct it if necessary; monitor the QT space. In case of torsade, do not administer antiarrhythmic (electrosystolic training).

Oral anticoagulants

  • Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and that of coagulation factors.
  • Haemorrhagic risk specific to corticosteroid therapy (digestive mucosa, vascular fragility) at high doses or in prolonged treatment longer than 10 days.
  • When the association is justified, strengthen monitoring: biological control on the 8th day, then every 15 days during corticosteroid therapy and after stopping it.

Other hypokalaemic drugs (hypokalaemic diuretics alone or in combination, stimulant laxatives, amphotericin B IV):

  • Increased risk of hypokalaemia by additive effect.
  • Monitor serum potassium, correct it if necessary, especially in the case of digitalis therapy.

Digital

  • Hypokalaemia promoting the toxic effects of digitalis.
  • Monitor serum potassium, correct it if necessary and possibly ECG.

Heparin parenterally

  • Aggravation by heparin of the hemorrhagic risk specific to corticosteroid therapy (digestive mucosa, vascular fragility) at high doses or in prolonged treatment longer than 10 days.
  • The association must be justified, strengthen surveillance.

Enzyme inducers (carbamazepine, phenobarbital, phenitoin primidone, rifabutin, rifampicin):

  • Decrease in plasma levels and the efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important in Addisonians and in cases of transplantation.
  • Clinical and biological monitoring, adjustment of the dosage of corticosteroids during the combination and after stopping the enzyme inducer.

Insulin, metformin, sulfonylureas

  • Elevation of blood sugar with sometimes ketosis (decrease in tolerance to carbohydrates by corticosteroids). Warn the patient and reinforce blood and urine self-monitoring, especially at the start of treatment. If necessary, adjust the dosage of the antidiabetic medication during treatment with corticosteroids and after stopping it.

Isoniazid (described for prednisolone)

  • Decreased plasma levels of isoniazid. Mechanism invoked: increased hepatic metabolism of isoniazid and decrease in that of glucocorticoids.
  • Clinical and biological monitoring.

Gastrointestinal topicals (salts, oxides and hydroxides of magnesium, aluminum and calcium (described for prednisolone, dexamethasone)):

  • Decreased digestive absorption of glucocorticoids.
  • Take gastrointestinal topicals away from glucocorticoids (more than 2 hours if possible).

Associations to take into account

Linked to the presence of betamethasone :

Antihypertensives

  • Decreased antihypertensive effect (hydrosodium retention of corticosteroids).

Interferon alpha

  • Risk of inhibition of the action of interferon.

Live attenuated vaccines

  • Risk of generalized, possibly fatal disease. This risk is increased in subjects already immunocompromised by the underlying disease.
  • Use an inactivated vaccine when it exists (poliomyelitis).

Related to the presence of dexchlorphenamine :

Other central nervous system depressants (sedative antidepressants, barbiturates, benzodiazepines, clonidine and related drugs, hypnotics, morphine derivatives (analgesics and cough suppressants), methadone, neuroleptics, anxiolytics):

  • Increase in central depression. Impaired vigilance can make driving and using machines dangerous.

Atropine and other atropine substances (imipramine antidepressants, antiparkinsonian anticholinergics, atropine antispasmodics, disopyramide, phenothiazine neuroleptics):

  • Addition of atropine side effects such as urinary retention, constipation, dry mouth.
  • Not applicable.

Effects on ability to Drive and use machines

  • Attention is drawn, in particular, to vehicle drivers and machine users to the possibilities of drowsiness associated with the use of this medicine.
  • This phenomenon is accentuated by the intake of alcoholic beverages or drugs containing alcohol.

Warnings and Precautions

Special warnings

BEFORE THE TREATMENT:

  • Tell your doctor in case of recent vaccination, in case of digestive ulcer, colon diseases, recent surgery in the intestine, diabetes, high blood pressure, infection (especially history of tuberculosis) , liver failure, kidney failure, osteoporosis and myasthenia gravis (muscle disease with muscle fatigue).
  • Tell your doctor if you are staying in the tropics, subtropics or southern Europe, due to the risk of parasitic disease.
  • This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (a rare hereditary disease).

DURING THE TREATMENT:

  • As a precaution, limit contact with people with chickenpox or measles.
  • Treatment of acute uterus will not exceed 10 days.
  • If symptoms persist or worsen, CONSULT YOUR DOCTOR.

Precautions for use

During treatment, your doctor may advise you to follow a diet, especially low in salt.

In the event of long-term disease of the liver or kidneys, CONSULT YOUR DOCTOR so that he can adjust the dosage.

The taking of this drug requires a MEDICAL ADVICE, in the elderly:

  • predisposed to constipation, dizziness or drowsiness,
  • having prostate problems;

TELL YOUR DOCTOR before taking an antihistamine.

Refrain from taking alcoholic beverages or medication containing alcohol during this treatment.

IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & sports

Pregnancy

  • It is possible to take this medicine during your pregnancy, as long as it is for a short time (a few days) and in the recommended doses.
  • At the end of pregnancy, excessive use of this medication can cause harmful effects in the newborn. Therefore, always seek the advice of your doctor before using it.

Feeding with milk

  • This medicine passes into breast milk. It is therefore not recommended for women who are breastfeeding.
  • Ask your doctor or pharmacist for advice before taking any medicine.

USE OF CELESTAMINE BY ATHLETES

This specialty contains an active ingredient that can induce a positive reaction to the tests performed during doping controls.

What happens if I overdose from celestamine ?

Symptoms of dexchlorphenamine overdose:

  • Convulsions (especially in infants and children)
  •  Impaired consciousness, coma;

symptomatic treatment be instituted in a specialized environment.

What should I do if I miss a dose?

  • Not applicable.
  • Not applicable.
  • Not applicable.

What happens if you stop taking celestamine ?

  • Not applicable.
  • Not applicable.
  • Not applicable.

What is  Forms and Composition ?

SHAPES and PRESENTATIONS

  • Tablet (pink):   Bottle of 30.

COMPOSITION

  p cp
Betamethasone 0.25 mg
Dexchlorpheniramine maleate 2 mg
  • Excipients: gelatin, erythrosine (E127), lactose monohydrate, corn starch, magnesium stearate.
  • Excipient with known effect: lactose monohydrate (172.173 mg / tab).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Celecoxib Sandoz Uses, Dosage, Side Effects, Precautions & Warnings https://edrug-online.com/2014/celecoxib-sandoz.html https://edrug-online.com/2014/celecoxib-sandoz.html#respond Mon, 16 Nov 2020 13:26:08 +0000 https://edrug-online.com/?p=2014 CELECOXIB SANDOZ 100 mg, capsule, box of 30CELECOXIB SANDOZ 100 mg, capsule, box of 30 >> Generic drug of the Therapeutic class: Anti-inflammatory Active ingredient: Celecoxib what is Celecoxib Sandoz medication used for and indication? CELECOXIB SANDOZ is indicated in adults for the relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective […]]]> CELECOXIB SANDOZ 100 mg, capsule, box of 30

CELECOXIB SANDOZ 100 mg, capsule, box of 30 >> Generic drug of the Therapeutic class: Anti-inflammatory

Active ingredient: Celecoxib

what is Celecoxib Sandoz medication used for and indication?

  • CELECOXIB SANDOZ is indicated in adults for the relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
  • The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of all the risks specific to each patient

Celecoxib Sandoz Dosage

Dosage

  • Due to the possible increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this medication should be prescribed at the minimum effective daily dose for the shortest possible time. The need for symptomatic treatment and its therapeutic efficacy for the patient should be reassessed periodically, in particular in patients with osteoarthritis (see sections Contraindications, Warnings and precautions for use, Adverse reactions and Pharmacodynamic properties).

Osteoarthritis

  • The usual recommended daily dose is 200 mg divided into one or two divided doses. In some patients whose symptoms are insufficiently relieved, increasing the dose to 200 mg twice daily may increase effectiveness. In the absence of improvement in therapeutic benefit after 2 weeks, other treatment options should be considered.

Rheumatoid arthritis

  • The recommended initial daily dose is 200 mg divided into 2 divided doses.
  • If necessary, the dose can be further increased to 200 mg twice a day. In the absence of improvement in therapeutic benefit after 2 weeks, other treatment options should be considered.

Ankylosing spondylitis

  • The recommended daily dose is 200 mg divided into one or two divided doses. For a small number of patients whose symptoms are insufficiently relieved, increasing the dose to 400 mg in one or two divided doses may increase effectiveness. In the absence of improvement in therapeutic benefit after 2 weeks, other treatment options should be considered.
  • The maximum recommended daily dose for all indications is 400 mg.

Special populations

Elderly (> 65 years old)

  • As for any patient, treatment will be started at 200 mg per day.
  • If necessary, the dose can be further increased to 200 mg twice a day. Special attention should be paid to elderly subjects with a body weight of less than 50 kg (see sections Warnings and precautions for use and Pharmacokinetic properties).

Pediatric population

CYP2C9 poor metabolisers

  • As the risk of dose-dependent adverse reactions is higher, celecoxib should be administered with caution to patients known or suspected to be poor metabolisers of CYP2C9, based on genotyping or history / previous experience with other substrates. CYP2C9. Dose reduction to half of the lowest recommended dose should be considered (see section 5.2).

Hepatic insufficiency

  • In patients with known moderate hepatic impairment with serum albumin between 25 and 35 g / l, treatment should be started at half the recommended dose. The experience in this type of patient is limited to that of cirrhotic patients (see sections Contraindications, Warnings and precautions for use and Pharmacokinetic properties).

Renal failure

  • As the experience with celecoxib in patients with mild to moderate renal impairment is limited, these patients should be treated with caution (see sections 4.3, 4.4 and Pharmacokinetics).

Celecoxib Sandoz Contraindications

Hypersensitivity to the active substance or to any of the excipients (see Composition)

  • · Known hypersensitivity to sulfonamides
    • – active peptic ulcer or gastrointestinal (GI) bleeding,
  • · A history of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs, including inhibitors COX-2,
    • – pregnancy and women of childbearing potential, in the absence of effective contraception (see section Fertility, pregnancy and lactation). In the two animal species studied, celecoxib caused malformations (see sections Fertility, pregnancy and lactation and Preclinical safety data). In humans, the risk during pregnancy is not known but cannot be excluded,
  • · Breastfeeding (see sections Fertility, pregnancy and lactation and Preclinical safety data)
  • · Severe hepatic impairment (serum albumin <25 g / l or Child-Pugh score of ≥ 10),
  • · Patients with clearance estimated creatinine <30 ml / min,
  • · Inflammatory bowel disease,
  • · Congestive heart failure (NYHA II-IV)
  • · Ischemic heart disease, peripheral arterial disease and / or cerebrovascular accident (including transient ischemic attack).

How To Take Celecoxib Sandoz ?

Administration mode

  • Oral route.
  • CELECOXIB SANDOZ can be taken with or without food. Patients who have difficulty swallowing the capsules can add the contents of the celecoxib capsule to applesauce, rice pudding, yogurt or mashed bananas. For this, the entire contents of the capsule must be emptied thoroughly into a level teaspoon of applesauce, rice pudding, yogurt or mashed banana cold or at room temperature and must be ingested. immediately with 240 ml of water. Once sprinkled on applesauce, rice pudding or yogurt, the content of the capsule remains stable for 6 hours placed in the refrigerator (between 2 and 8 ° C). If the contents of the capsule are sprinkled over mashed bananas, they should not be refrigerated and should be immediately ingested.

how does Celecoxib Sandoz work?

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, antirheumatic drug, NSAIDs, Coxibs, ATC code: M01AH01 .

Action mechanism

  • Celecoxib is a selective oral cyclooxygenase-2 (COX-2) inhibitor at doses used clinically (200 mg to 400 mg per day). No statistically significant inhibition of COX-1 assessed by ex-vivo inhibition of thromboxane B2 (TxB2) formation was observed at these doses in healthy volunteers.

Pharmacodynamic effects

  • Cyclo-oxygenase is responsible for the synthesis of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. Cyclo-oxygenase-2 (COX-2) is the isoform of the enzyme induced by pro-inflammatory stimuli and is believed to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and pain. fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and certain functions of the CNS (induction of fever, pain perception and cognitive function). It could also play a role in the healing of ulcers. COX-2 has been demonstrated in the tissues around gastric ulcers in humans, but its implication in the healing of ulcers is not
  • The difference in antiplatelet activity between some COX-1 inhibitor NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk for thromboembolic reactions. Selective COX-2 inhibitors reduce systemic (and therefore possibly endothelial) prostacyclin formation without altering platelet thromboxane.
  • Celecoxib is a pyrazole derivative substituted with two aryl groups, a chemical analogue of other non-arylamine sulfonamides (eg thiazides, furosemide) but it differs from arylamine sulfonamides (eg sulfamethoxazole and other sulfonamide antibiotics).
  • A dose-dependent effect on TxB2 formation has been observed after high doses of celecoxib. However, in healthy subjects and in small, multi-dose studies with 600 mg twice daily (equivalent to three times the highest recommended dose), celecoxib had no effect on platelet aggregation. nor on bleeding time compared to placebo.

Clinical efficacy and safety

  • Several clinical trials confirming the efficacy and safety of celecoxib in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis have been performed. Celecoxib has been evaluated for 12 weeks in the treatment of inflammation and pain of osteoarthritis of the knee and hip in approximately 4,200 patients in placebo-controlled trials and benchmarks. It has also been evaluated for 24 weeks in the treatment of inflammation and pain in rheumatoid arthritis in approximately 2,100 patients in placebo-controlled trials and reference products. Celecoxib, 200 mg to 400 mg daily, provided pain relief within 24 hours of administration.
  • Celecoxib has been evaluated for 12 weeks in the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo-controlled trials and benchmarks. In these trials celecoxib, at doses of 100 mg twice daily, 200 mg once daily, 200 mg twice daily and 400 mg once daily, demonstrated significant improvement in pain, index overall disease activity and function in ankylosing spondylitis.
  • Five randomized, double-blind controlled trials, including endoscopy of the upper gastrointestinal tract, were conducted at doses of 50 to 400 mg, twice daily, of celecoxib in approximately 4,500 patients without initial ulceration. In 12 week endoscopic studies versus naproxen (1000 mg per day) and ibuprofen (2400 mg per day), celecoxib (100 to 800 mg per day) was associated with a significantly lower risk of peptic ulcers.
  • The data obtained in comparison with diclofenac (150 mg per day) were inconsistent. In two of the 12-week studies, the percentage of patients with peptic ulceration detected by endoscopy was not significantly different on placebo, celecoxib 200 mg twice daily and celecoxib 400 mg twice daily.
  • In a prospective long-term safety study (duration 6 to 15 months, CLASS study), 5,800 patients with osteoarthritis and 2,200 patients with rheumatoid arthritis received celecoxib 400 mg twice daily (i.e. four times and two times a day, respectively). times the recommended dosage for osteoarthritis and rheumatoid arthritis), ibuprofen 800 mg three times a day or diclofenac 75 mg twice a day (each in therapeutic doses). Twenty-two percent of the patients included were simultaneously taking low doses of acetylsalicylic acid (≤ 325 mg per day), mainly for cardiovascular prevention. With regard to the primary endpoint designated as complicated ulcers (defined as bleeding,
  • There was also no statistically significant difference in the combined NSAID group for complicated ulcers (relative risk 0.77; 95% CI 0.41 – 1.46; values ​​based on the entire duration of the study). For the mixed endpoint of complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group (relative risk 0.66; 95% CI 0.45 – 0.97), but not between celecoxib and diclofenac. Patients taking celecoxib and low doses of acetylsalicylic acid at the same time had 4-fold higher rates of complicated ulcers compared to those taking celecoxib alone. The incidence of clinically significant drops in hemoglobin (> 2 g / dl), confirmed by repeated dosages, was significantly lower in patients receiving celecoxib compared to the NSAID group (relative risk 0.29; 95% CI 0.17 – 0.48). The significantly lower incidence of this event with celecoxib was maintained with or without taking acetylsalicylic acid.
  • p = 0.0001). The rates of gastrointestinal complications with clinical manifestation such as perforation, obstruction or hemorrhage were very low and not different between treatment groups (4-5 per group).
  • Cardiovascular safety – Long-term studies in patients with sporadic adenomatous polyps.
  • Two studies evaluating celecoxib in subjects with sporadic adenomatous polyps have been conducted: the APC (Adenoma Prevention with Celecoxib) trial and the PreSAP (Prevention of Spontaneous Adenomatous Polyps) trial.
  • In the APC trial, a dose-dependent increase in the composite endpoint combining cardiovascular death, myocardial infarction (MI) and Cerebral Vascular Accident (CVA) was observed with celecoxib compared to placebo over 3 years of treatment. The PreSAP trial did not show a statistically significant increase in risk for the same composite endpoint.
  • In the APC trial, the relative risk of cardiovascular death, MI and stroke (composite endpoint) was 3.4 (95% CI 1.4-8.5) with 400 mg of celecoxib twice daily and 2.8 (95% CI 1.1-7.2) with 200 mg celecoxib twice daily compared to placebo. The cumulative values ​​for this composite endpoint over a 3-year period were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively compared to 0.9% (6/679 subjects) for the placebo. The increases observed compared to placebo for the two celecoxib dose groups were mainly due to an increased incidence of myocardial infarction.
  • In the PreSAP trial, the relative risk for this same composite endpoint was 1.2 (95% CI 0.6-2.4) with celecoxib 400 mg twice daily compared to placebo. The cumulative values ​​for this composite endpoint over a 3-year period were 2.3% (21/933 subjects) and 1.9% (12/628 subjects) for celecoxib and placebo, respectively. The incidence of myocardial infarction number was 1.0% (9/933 subjects) with a daily administration of 400 mg of celecoxib and 0.6% (4/628 subjects) with placebo.
  • Data from a third long-term study, ADAPT (The Alzheimer’s Disease Anti-inflammatory Prevention Trial) did not show a significant increase in cardiovascular risk with celecoxib 200 mg twice daily compared to placebo. The relative risk for a similar composite endpoint (cardiovascular death, myocardial infarction, stroke) was 1.14 (95% CI 0.61 – 2.15) with 200 mg celecoxib twice daily compared to placebo . The incidence of myocardial infarction was 1.1% (8/717 patients) with 200 mg celecoxib twice daily and 1.2% (13/1070 patients) with placebo.

A prospective randomized evaluation integrating celecoxib versus ibuprofen or naproxen (PRECISION – Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen)

  • The PRECISION study is a double-blind study of cardiovascular safety in patients with osteoarthritis or rheumatoid arthritis at high risk of cardiovascular disease, comparing celecoxib (200 – 400 mg per day) with naproxen (750 – 1000 mg per day) and ibuprofen (1800 – 2400 mg per day). The primary endpoint, the Antiplatelet Trialists Collaboration (APTC), was a composite endpoint assessed independently of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke. The study was planned to have 80% power to assess non-inferiority. Of the’ Open-label esomeprazole (20 – 40 mg) has been prescribed to all patients for gastric protection. Patients on low dose aspirin were allowed to continue treatment; at baseline, nearly half of the subjects were taking aspirin. Secondary and tertiary endpoints included cardiovascular, gastrointestinal and renal outcomes. The mean administered dose was 209 ± 37 mg / day for celecoxib, 2045 ± 246 for ibuprofen and 852 ± 103 for naproxen.
  • For the primary endpoint, celecoxib compared to naproxen or ibuprofen met all four pre-established non-inferiority criteria, see Table 2.
  • Other independently assessed secondary and tertiary outcomes included cardiovascular, gastrointestinal, and renal outcomes. In addition, a four-month study investigating the effects of the three drugs on blood pressure, as measured by outpatient monitoring (ABPM), was conducted.

Table 2. Main analysis of the APTC composite endpoint evaluated

Analysis of the intent-to-treat (ITT – Intent to treat until 30 th month)
Celecoxib 100 – 200 mg twice daily Ibuprofen 600 – 800 mg three times a day Naproxen 375 – 500 mg twice daily
NOT 8,072 8,040 7 969
Subjects presenting events 188 (2.3%) 218 (2.7%) 201 (2.5%)
Pairwise comparison Celecoxib versus naproxen Celecoxib versus ibuprofen Ibuprofen versus naproxen
RR (95% CI) 0.93 (0.76, 1.13) 0.86 (0.70, 1.04) 1.08 (0.89, 1.31)
Analysis of the population in modified intent to treat (MITT under treatment until 43 th month)
Celecoxib 100 – 200 mg twice daily Ibuprofen 600 – 800 mg three times a day Naproxen 375 – 500 mg twice daily
NOT 8,030 7 990 7 933
Subjects presenting events 134 (1.7%) 155 (1.9%) 144 (1.8%)
Pairwise comparison Celecoxib versus naproxen Celecoxib versus ibuprofen Ibuprofen versus naproxen
RR (95% CI) 0.90 (0.72, 1.14) 0.81 (0.64, 1.02) 1.12 (0.889; 1.40)

Overall, the results were numerically similar in the celecoxib and comparator groups for the secondary and tertiary endpoints, and overall, no unexpected safety results were observed.

Celecoxib Sandoz Side Effects

Adverse events listed by system organ class and classified by frequency in Table 1 correspond to data presented in the following sources:

  • adverse events reported at incidence rates greater than 0.01% and greater than those reported for placebo in 12 placebo-controlled clinical trials and standard treatment, conducted for up to 12 weeks in patients with d osteoarthritis and rheumatoid arthritis treated with daily doses of celecoxib of 100 mg to 800 mg. In additional studies using comparators such as non-selective NSAIDs, approximately 7,400 patients with OA were treated with celecoxib at daily doses up to 800 mg, of which approximately 2,300 patients were treated for 1 year or more. more. The adverse events seen with celecoxib in these additional studies were consistent with those seen in patients with
  • Adverse events reported at higher rates than placebo for subjects treated with celecoxib 400 mg daily for the long term testing, for a maximum of 3 years, in preventing polyps (Adenoma Prevention with Celecoxib trial (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP); see section Pharmacodynamic properties, Cardiovascular safety – Long-term studies in patients with sporadic adenomatous polyps),

spontaneously reported post-marketing adverse events over a period in which it is estimated that over 70 million patients have been treated with celecoxib (various doses, durations and indications). Although these were identified as effects from post-marketing reports, trial data were consulted to estimate frequency. Frequencies are based on a cumulative meta-analysis pooling trials pooling exposure from 38,102 patients.

Table 1. Adverse reactions observed in clinical trials with celecoxib and during postmarketing surveillance (MedDRA terms) 1,2

Frequency of adverse reactions
System organ class Very common

(≥1 / 10)

Frequent

(≥1 / 100 to <1/10)

Rare

(≥1 / 1,000 to <1/100)

Rare

(≥1 / 10,000 to <1 / 1,000)

Very rare

(<1 / 10,000)

Frequency not known
Infections and infestations Sinusitis, upper respiratory tract infection, pharyngitis, urinary tract infection
Blood and lymphatic system disorders Anemia Leukopenia, thrombocytopenia Pancytopenia4
Immune system disorders Hypersensitivity Anaphylactic shock4, anaphylactic reaction4
Metabolism and nutrition disorders Hyperkalaemia
Psychiatric disorders Insomnia Anxiety, depression, fatigue Confusional state, hallucinations4
Nervous system disorders Dizziness, hypertonia, headache4 Cerebral infarction1, paraesthesia, somnolence Ataxia, dysgeusia Intracranial haemorrhage (including fatal intracranial haemorrhage) 4, aseptic meningitis4, epilepsy (including worsening epilepsy) 4, ageusia4, anosmia4
Eye disorders Blurred vision, conjunctivitis4 Eye bleeding4 Retinal artery occlusion4, retinal vein occlusion4
Ear and labyrinth disorders Tinnitus, hearing loss1
Cardiac disorders Myocardial infarction1 Heart failure, palpitations, tachycardia Arrhythmia4
Vascular disorders Hypertension1 (including worsening hypertension) Pulmonary embolism4, flushing4 Vasculitis4
Respiratory, thoracic and mediastinal disorders Rhinitis, cough, dyspnea1 Bronchospasm4 Inflammatory lung disease4
Gastrointestinal disorders Nausea4, abdominal pain, diarrhea, dyspepsia, gas, vomiting1, dysphagia1 Constipation, gastritis, stomatitis, gastrointestinal inflammation (including worsening gastrointestinal inflammation), belching Gastrointestinal bleeding4, duodenal ulcer, gastric ulcer, esophageal ulcer, intestinal ulcer and large intestinal ulcer, intestinal perforation, esophagitis, melena, pancreatitis, colitis4
Hepatobiliary disorders Abnormal liver function, increased liver enzyme levels (including increased ALT and AST) Hepatitis4 Hepatic failure4 (sometimes fatal or requiring liver transplantation), fulminant hepatitis4, (sometimes fatal), hepatic necrosis4, cholestasis4, cholestatic hepatitis4, jaundice4
Skin and subcutaneous tissue disorders Rash, pruritus (includes generalized pruritus) Urticaria, bruising4 Angioedema4, alopecia, photosensitivity Exfoliative dermatitis4, erythema multiforme4, Stevens-Johnson syndrome4, Lyell syndrome4, drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS) 4, acute generalized exanthemous pustulosis (AGEP) 4, bullous dermatitis4
Musculoskeletal and connective tissue disorders Arthralgia4 Muscle contractures (lower limb cramps) Myositis4
Kidney and urinary tract disorders Blood creatinine increased, blood urea increased Acute renal failure4, hyponatremia4 Tubulointerstitial nephritis4, nephrotic syndrome4, minimal lesion glomerulonephritis4
Reproductive system and breast disorders Menstrual disorders4 Female infertility (decrease in fertility in women) 3
General disorders and administration site conditions Flu-like syndrome, peripheral edema / fluid retention Face edema, chest pain4
Injury, poisoning and procedural complications Injury (accidental injury)
1 Adverse reactions occurring in polyp prevention studies in subjects treated with 400 mg celecoxib per day in two clinical trials of up to 3 years duration (APC and PreSAP trials). The adverse reactions listed above for polyp prevention trials are only those already identified during pharmacovigilance notifications or which occurred more frequently than in osteoarthritis trials.

² In addition, the following previously unknown adverse reactions occurred in polyps prevention studies involving subjects treated with 400 mg celecoxib per day in two clinical trials lasting up to 3 years (APC and PreSAP trials):

Common: angina pectoris, irritable bowel syndrome, nephrolithiasis, increased blood creatinine, benign prostatic hyperplasia, weight gain.

Uncommon: helicobacter infection, shingles, erysipelas, bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous floaters, conjunctival haemorrhage, deep vein thrombosis, dysphonia, haemorrhoidal haemorrhage, frequent stools, mouth ulcers, allergic dermatitis, lymph nodes nocturia, vaginal haemorrhages, breast tenderness, lower limb fracture, increased sodium in the blood.

3 Women who wish to have a child are excluded from all studies. Therefore, consulting the study database to determine the frequency of this event was not valid.

4 Frequencies based on a cumulative meta-analysis pooling the trials grouping the exposure of 38,102 patients.

Evaluation of the final results of the APC and PreSAP trials (pooled data from the two trials; for the results of the individual trials, see section 5.1), for patients treated with 400 mg celecoxib per day for up to 3 years showed a increase in the number of myocardial infarctions of 7.6 events per 1000 patients (uncommon) compared to placebo; no increase in the number of strokes (undifferentiated types) was observed compared to placebo.

Celecoxib Sandoz Interactions

Pharmacodynamic interactions

Anti coagulants

  • Anticoagulant activity should be monitored in patients taking warfarin or similar products, especially in the first few days after initiating or modifying the dosage of celecoxib as these patients have an increased risk of bleeding complications. For this reason, the use of oral anticoagulants should be accompanied by close monitoring of the prothrombin INR level of patients, mainly during the first days after initiation of treatment with celecoxib or when the dosage of the drug is changed. celecoxib (see section Warnings and precautions for use). Bleeding, some with fatal outcome, associated with an increase in the prothrombin level and INR have been observed in patients, especially in the elderly,

Anti-hypertensives

  • NSAIDs may reduce the effects of antihypertensive drugs, including ACE inhibitors, angiotensin II receptor blockers, diuretics, and beta blockers. As with NSAIDs, the risk of acute renal failure, which is generally reversible, may be increased in certain patients with impaired renal function (for example: dehydrated patients or elderly patients) when the combination of ACE inhibitors, antagonists of the receptors of angiotensin II, and / or diuretics with NSAIDs, including celecoxib (see section 4.4). Therefore, this combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and renal function should be monitored after
  • In a 28-day clinical study in patients with stage I and stage II hypertension controlled by lisinopril, administration of 200 mg celecoxib twice daily did not result in a clinical increase. significant systolic or diastolic blood pressure compared to placebo. Assessment was performed by ambulatory blood pressure monitoring for 24 hours. Among the patients treated with 200 mg celecoxib twice daily, 48% of them were considered non-responders to lisinopril at the final clinical visit compared to 27% of patients treated with placebo (were defined as non-responders, subjects whose diastolic blood pressure measured with a blood pressure monitor> 90 mmHg or whose

Ciclosporin and tacrolimus

  • Co-administration of NSAIDs with ciclosporin or tacrolimus may increase the nephrotoxicity of ciclosporin or tacrolimus, respectively. Renal function should be monitored if celecoxib is combined with any of these drugs.

Acetylsalicylic acid

  • Celecoxib can be used in combination with a low dose of acetylsalicylic acid but cannot be used as a substitute for acetylsalicylic acid for cardiovascular prevention. In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications was demonstrated with the concomitant administration of low doses of acetylsalicylic acid, in comparison for the use of celecoxib alone .

Pharmacokinetic interactions

Effects of celecoxib on other drugs

CYP2D6 inhibition

  • Celecoxib is an inhibitor of cytochrome CYP2D6. The plasma concentrations of drugs which are substrates of this enzyme may be increased when combined with celecoxib. Drugs metabolized by CYP2D6 are, for example, antidepressants (tricyclics and selective serotonin reuptake inhibitors), neuroleptics, antiarrhythmics, etc. The dosage of CYP2D6 substrates, the dose of which is appropriate for each patient, may be reduced if necessary at the start of treatment with celecoxib or increased when stopping treatment with celecoxib.
  • Concomitant administration of 200 mg celecoxib twice daily resulted in 2.6-fold and 1.5-fold increased plasma concentrations of dextromethorphan and metoprolol (substrates of CYP2D6), respectively. These increases are due to the inhibition of the metabolism of CYP2D6 substrates by celecoxib.

CYP2C19 inhibition

  • In vitro studies have shown that celecoxib has the potential to inhibit the metabolism catalyzed by the cytochrome CYP2C19. The clinical significance of this in vitro observation is not known. Drugs metabolized by CYP2C19 are, for example, diazepam, citalopram and imipramine.

Methotrexate

  • In patients with rheumatoid arthritis, celecoxib has no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (at the doses used in rheumatology). However, adequate monitoring of methotrexate toxicity should be considered when combining these two drugs.

Lithium

  • In healthy subjects, the concomitant administration of 200 mg twice daily of celecoxib and 450 mg twice daily of lithium resulted in a mean increase of 16% in Cmax and 18% in AUC of lithium. Therefore, patients treated with lithium should be closely monitored when initiating or stopping celecoxib.

Oral contraceptives

  • In an interaction study, celecoxib did not have clinically significant effects on the pharmacokinetics of oral contraceptives (1 mg norethisterone / 35 µg ethinyl estradiol).

Glibenclamide / tolbutamide

  • Celecoxib does not affect the pharmacokinetics of tolbutamide (cytochrome CYP2C9 substrate) or glibenclamide in a clinically meaningful way.

Effect of other drugs on celecoxib

CYP2C9 poor metabolisers

  • In subjects who are poor metabolizers of CYP2C9 with increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors, such as fluconazole, may further increase exposure to celecoxib. Such combinations should be avoided in known poor metabolisers of CYP2C9 .

CYP2C9 inhibitors and inducers

  • Since celecoxib is primarily metabolized by cytochrome CYP2C9, it should be used at half the recommended dose in patients treated with fluconazole. Concomitant use of a single 200 mg dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in Cmax of 60% and AUC of 130 % of celecoxib. Concomitant use with CYP2C9 inducers such as rifampicin, carbamazepine, or barbiturates may result in reduced plasma concentrations of celecoxib.

Ketoconazole and antacids

  • No changes in the pharmacokinetics of celecoxib have been observed with ketoconazole or antacids.

Pediatric population

  • Interaction studies have only been performed in adults.

Warnings and Precautions

Gastrointestinal (GI) effects

  • Upper and lower gastrointestinal complications [perforations, ulcers or hemorrhages (PUH)], some with fatal outcome, have been observed in patients treated with celecoxib.
  • Caution should be exercised in patients most at risk of developing a gastrointestinal complication with NSAIDs: the elderly, patients also treated with other NSAIDs, or with acetylsalicylic acid, with glucocorticoids, patients consuming alcohol, or patients with a history of gastrointestinal illness such as ulcer and bleeding.
  • There is an increased risk of gastrointestinal side effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is used in combination with acetylsalicylic acid (even at low doses).
  • A significant difference in gastrointestinal tolerance between the combination of selective COX-2 inhibitors and acetylsalicylic acid compared to the combination of NSAIDs and acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section Pharmacodynamic properties).

Concomitant use of NSAIDs

  • Concomitant use of celecoxib and an NSAID other than aspirin should be avoided.

Cardiovascular effects

  • In comparison to placebo, an increase in the number of serious cardiovascular events, mainly myocardial infarctions, was observed in a long-term study in patients with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg twice per day and 400 mg twice daily.
  • Due to the possible increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this medication should be prescribed at the minimum effective daily dose for the shortest possible time. The need for symptomatic treatment and its therapeutic efficacy for the patient should be reassessed periodically, in particular in patients with osteoarthritis (Contraindications, Adverse reactions and Pharmacodynamic properties).
  • Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes, smoking) should be treated with celecoxib only after careful evaluation.
  • Due to their lack of antiplatelet effects, selective COX-2 inhibitors cannot be substituted for acetylsalicylic acid in the prevention of cardiovascular thromboembolic diseases. Therefore, antiplatelet therapy should not be stopped.

Fluid retention and edema

  • As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in patients treated with celecoxib. Therefore celecoxib should be administered with caution in patients with a history of heart failure, left ventricular dysfunction or arterial hypertension and in patients with pre-existing edema regardless of its origin because inhibition of Prostaglandins can cause deterioration of kidney function and fluid retention. Precautions will also be necessary in patients treated with diuretics or at risk of hypovolaemia.

Hypertension

  • Like all NSAIDs, celecoxib can cause hypertension or worsen pre-existing hypertension, thus increasing the incidence of cardiovascular events. Close monitoring of blood pressure at the start of treatment with celecoxib and then during treatment should therefore be carried out.

Renal and hepatic effects

  • The existence of impaired renal or hepatic function, and particularly cardiac dysfunction, is more likely in the elderly. Therefore, appropriate medical surveillance should be ensured.
  • NSAIDs, including celecoxib, may be responsible for renal toxicity. Clinical trials with celecoxib have shown renal effects similar to those seen with comparator NSAIDs. The patients most at risk of developing renal toxicity are patients with renal failure, heart failure, hepatic disorders, and the elderly. These patients should be closely monitored while receiving celecoxib therapy.
  • A few cases of serious hepatic reactions have been reported with celecoxib, including fulminant hepatitis (some fatal), hepatic necrosis and hepatic failure (some fatal or requiring liver transplantation). In cases for which time to onset was reported, most serious hepatic reactions occurred within one month of starting treatment .
  • During treatment, appropriate measures will be taken and discontinuation of celecoxib treatment should be considered if there is any functional deterioration of the above mentioned organs.

CYP2D6 inhibition

  • Celecoxib inhibits CYP2D6. Even though it is not a strong inhibitor of this enzyme, a dosage reduction may be necessary for medicines whose dose is adjusted for each patient and which are metabolized by CYP2D6 . and other forms of interactions).

CYP2C9 poor metabolisers

  • Patients known to be poor metabolisers of CYP2C9 should be treated with caution.

Skin reactions and systemic hypersensitivity reactions

  • Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and Lyell syndrome, have been very rarely reported in association with the use of celecoxib (see section 4.8). The risk of these effects occurring seems to be greatest at the start of treatment, the onset of these effects occurring in the majority of cases during the first month of treatment. Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib .
  • Patients with a history of allergy to sulfonamides or to any other medication may be at increased risk of serious skin reactions or hypersensitivity . Celecoxib should be stopped at the first sign of skin rash, mucosal damage, or any other sign of hypersensitivity.

General effects

  • Celecoxib may mask fever and other signs of inflammation.

Use with oral anticoagulants

  • In patients treated with warfarin, severe bleeding has been reported. An increased prothrombin time (INR) has been reported with concomitant treatments. It should therefore be closely monitored in patients receiving warfarin / oral coumarin-type anticoagulants, particularly when initiating therapy with celecoxib or when the dose of celecoxib is changed (see section 4.5). and other forms of interactions). The concomitant use of anticoagulants and NSAIDs may increase the risk of bleeding. Caution should be exercised when co-administering celecoxib with warfarin or other oral anticoagulants, including with newer anticoagulants (for example: apixaban,

Excipients

  • CELECOXIB SANDOZ contains lactose. Patients with galactose intolerance, lactase deficiency, or glucose or galactose malabsorption syndrome (rare hereditary diseases) should not take this medicine.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

  • Studies in animals (rats and rabbits) have shown toxicity on the reproductive functions including malformations (see sections Contra-indications and Preclinical safety data). Inhibition of prostaglandin synthesis could have a deleterious effect on pregnancy. Data from epidemiological studies point to an increased risk of spontaneous miscarriages after the use of prostaglandin synthesis inhibitors in early pregnancy. In humans, the risk during pregnancy is unknown but cannot be excluded. Like other drugs that inhibit prostaglandin synthesis, celecoxib can cause uterine inertia and premature closure of the ductus arteriosus in the last trimester of pregnancy. Celecoxib is contraindicated during pregnancy and in women who may become pregnant (see sections Contraindications and Warnings and precautions for use). If pregnancy is discovered during treatment, celecoxib should be stopped.

Feeding with milk

  • Celecoxib is excreted in the milk of rats at concentrations similar to those found in plasma. Administration of celecoxib to a small number of breastfeeding women has shown very little passage of celecoxib into breast milk. Patients treated with celecoxib should not breast-feed.

Fertility

  • Due to their mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women.

What happens if I overdose from Celecoxib Sandoz ?

There is no clinical experience with overdose. Single doses up to 1200 mg and repeated doses up to 1200 mg, twice daily, have been administered for 9 days to healthy subjects without causing clinically significant adverse effects. 

In the event of a possible overdose, appropriate medical management is necessary, for example evacuation of gastric contents, clinical monitoring and, if necessary, symptomatic treatment. 

Dialysis is unlikely to be an effective means of eliminating the drug due to its strong protein binding.

What is  Forms and Composition ?

Appearance and shape

  • Capsule.
  • White, opaque capsule. The body contains a blue stripe with the text “C9OX – 100” written in white.
  • Box of 1, 10, 20, 30, 40, 50, 60 and 100 capsules in blister packs (PVC / Aluminum).
  • Not all presentations may be marketed.

Other shapes

  • CELECOXIB SANDOZ 200 mg, hard capsule, box of 30.

Composition

Active ingredient Capsule
Celecoxib 100 mg *

* per unit dose

Active ingredients: Celecoxib

Excipients with known effects ?

  • Capsule contents: Lactose monohydrate, Propylene glycol
Other excipients: Povidone, Croscarmellose sodium, Sodium lauryl sulphate, Magnesium stearate, Capsule shell: Gelatin, Titanium dioxide, Yellow iron oxide, Printing ink: Shellac, Indigo carmine aluminum lake

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Celecoxib Pfizer Uses, Dosage, Side Effects, Precautions & Warnings https://edrug-online.com/2011/celecoxib-pfizer.html https://edrug-online.com/2011/celecoxib-pfizer.html#respond Tue, 06 Oct 2020 09:37:06 +0000 https://edrug-online.com/?p=2011 CELECOXIB PFIZER 100 mg, hard capsule, box of 30Generic drug of the Therapeutic class: Anti-inflammatory Active ingredient: Celecoxib what is Celecoxib Pfizer ? CELECOXIB PFIZER belongs to the class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) and more specifically to the subgroup of cyclo-oxygenases-2 (COX-2) inhibitors.  Your body produces prostaglandins which can cause pain and inflammation. In conditions like osteoarthritis and rheumatoid arthritis, your body produces […]]]> CELECOXIB PFIZER 100 mg, hard capsule, box of 30

Generic drug of the Therapeutic class: Anti-inflammatory

Active ingredient: Celecoxib

what is Celecoxib Pfizer ?

  • CELECOXIB PFIZER belongs to the class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) and more specifically to the subgroup of cyclo-oxygenases-2 (COX-2) inhibitors. 
  • Your body produces prostaglandins which can cause pain and inflammation. In conditions like osteoarthritis and rheumatoid arthritis, your body produces more of it. 
  • CELECOXIB PFIZER works by decreasing the production of prostaglandins and thus decreasing pain and inflammation.
  • You should expect the medicine to start working within hours of taking the first dose, but it may take a few days of treatment to achieve full effect.

what is Celecoxib Pfizer medication used for and indication?

CELECOXIB PFIZER is indicated in adults for the relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of all the risks specific to each patient. employment).

Celecoxib Pfizer Dosage

Due to the possible increase in cardiovascular (CV) risks of celecoxib depending on the dose and duration of treatment, this medication should be prescribed at the minimum effective daily dose for the shortest possible time. The need for symptomatic treatment and its therapeutic efficacy for the patient should be reassessed periodically, in particular in patients with osteoarthritis (see sections Contraindications, Warnings and precautions for use, Adverse reactions and Pharmacodynamic properties).

Osteoarthritis

  • The usual recommended daily dose is 200 mg divided into one or two divided doses. In some patients whose symptoms are insufficiently relieved, increasing the dose to 200 mg twice daily may increase effectiveness. In the absence of improvement in therapeutic benefit after 2 weeks, other treatment options should be considered.

Rheumatoid arthritis

  • The recommended initial daily dose is 200 mg divided into 2 divided doses.
  • If necessary, the dose can be further increased to 200 mg twice a day. In the absence of improvement in therapeutic benefit after 2 weeks, other treatment options should be considered.

Ankylosing spondylitis 

  • The recommended daily dose is 200 mg divided into one or two divided doses. For a small number of patients whose symptoms are insufficiently relieved, increasing the dose to 400 mg in one or two divided doses may increase effectiveness. In the absence of improvement in therapeutic benefit after 2 weeks, other treatment options should be considered.
  • The maximum recommended daily dose for all indications is 400 mg.

Special populations

The elderly

  • As for any patient, treatment will be started at 200 mg per day.
  • If necessary, the dose can be further increased to 200 mg twice a day. Special attention should be paid to elderly subjects with a body weight of less than 50 kg (see sections Warnings and precautions for use and Pharmacokinetic properties).

Pediatric population

CYP2C9 poor metabolisers

  • As the risk of dose-dependent adverse reactions is higher, celecoxib should be administered with caution to patients known or suspected to be poor metabolisers of CYP2C9, based on genotyping or history / previous experience with other substrates. CYP2C9. Dose reduction to half of the lowest recommended dose should be considered.

Hepatic insufficiency

  • In patients with known moderate hepatic impairment with serum albumin between 25 and 35 g / l, treatment should be started at half the recommended dose. The experience in this type of patient is limited to that of cirrhotic patients (see sections Contraindications, Warnings and precautions for use and Pharmacokinetic properties).

Renal failure

  • As the experience with celecoxib in patients with mild to moderate renal impairment is limited, these patients should be treated with caution (Pharmacokinetics).

Celecoxib Pfizer Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section composition.

  • Known hypersensitivity to sulfonamides.
  • Active peptic ulceration or gastrointestinal bleeding (GI).
  • History of asthma, acute rhinitis, nasal polyps, angioedema, urticaria and other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other anti-inflammatory drugs ( NSAIDs), including COX-2 inhibitors.
  • Pregnancy and Women of childbearing age in the absence of effective contraception (see section Fertility, pregnancy and lactation). In the two animal species studied, celecoxib caused malformations (see sections Fertility, pregnancy and lactation and Preclinical safety data). In humans, the risk during pregnancy is not known but cannot be excluded.

Breast-feeding (see sections Fertility, pregnancy and lactation and Preclinical safety data).

  • Severe hepatic impairment (serum albumin <25 g / l or Child-Pugh score ³ 10).
  • Patients with estimated creatinine clearance <30 ml / min.
  • Inflammatory bowel disease.
  • Congestive heart failure (NYHA II-IV).

Established ischemic heart disease, peripheral arterial disease and / or history of stroke (including transient ischemic attack).

How To Take Celecoxib Pfizer ?

Administration mode

  • CELECOXIB PFIZER capsules should be taken by mouth . The capsules can be taken at any time of the day, with or without food. However, try to take each dose of CELECOXIB PFIZER at the same time of the day.
  • If you have difficulty swallowing the capsules: The entire contents of the capsule can be sprinkled on a level teaspoonful of semi-solid food (such as applesauce, rice pudding, yogurt or mashed bananas (cold or at room temperature) and swallowed immediately with a glass of about 240 ml of water.
  • To open the capsule, hold it vertically so that the granules remain at the bottom, then lightly pinch the top part and turn it to remove it, being careful not to spill the contents. The granules should not be chewed or crushed.
  • If you do not feel any improvement after two weeks of treatment, contact your doctor.

how does Celecoxib Pfizer work?

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, antirheumatic drug, NSAIDs, Coxibs, ATC code: M01AH01.

Action mechanism

  • Celecoxib is a selective oral COX-2 inhibitor at doses used clinically (200 mg to 400 mg per day). No statistically significant inhibition of COX-1 assessed by ex-vivo inhibition of thromboxane B2 (TxB2) formation was observed at these doses in healthy volunteers.

Pharmacodynamic effects

  • Cyclo-oxygenase is responsible for the synthesis of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. Cyclo-oxygenase-2 (COX-2) is the isoform of the enzyme induced by pro-inflammatory stimuli and is believed to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and pain. fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and certain functions of the CNS (induction of fever, pain perception and cognitive function). It could also play a role in the healing of ulcers. COX-2 has been demonstrated in the tissues around gastric ulcers in humans, but its implication in the healing of ulcers is not
  • The difference in antiplatelet activity between some COX-1 inhibitor NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk for thromboembolic reactions. Selective COX-2 inhibitors reduce systemic (and therefore possibly endothelial) prostacyclin formation without altering platelet thromboxane.
  • Celecoxib is a pyrazole derivative substituted with two aryl groups, a chemical analogue of other non-arylamine sulfonamides (eg thiazides, furosemide) but it differs from arylamine sulfonamides (eg sulfamethoxazole and other sulfonamide antibiotics).
  • A dose-dependent effect on TxB2 formation has been observed after high doses of celecoxib. However, in healthy subjects and in small, multi-dose studies with 600 mg twice daily (equivalent to three times the highest recommended dose), celecoxib had no effect on platelet aggregation. nor on bleeding time compared to placebo.

Clinical efficacy and safety

  • Several clinical trials confirming the efficacy and safety of celecoxib in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis have been performed. Celecoxib has been evaluated for 12 weeks in the treatment of inflammation and pain of osteoarthritis of the knee and hip in approximately 4,200 patients in placebo-controlled trials and benchmarks. It has also been evaluated for 24 weeks in the treatment of inflammation and pain in rheumatoid arthritis in approximately 2,100 patients in placebo-controlled trials and reference products. Celecoxib, 200 mg to 400 mg daily, provided pain relief within 24 hours of administration. Celecoxib has been evaluated for 12 weeks in the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo-controlled trials and benchmarks. In these trials celecoxib, at doses of 100 mg twice daily, 200 mg once daily, 200 mg twice daily and 400 mg once daily, demonstrated a significant improvement in pain, overall index of disease activity and function in ankylosing spondylitis.
  • Five randomized, double-blind controlled trials, including endoscopy of the upper gastrointestinal tract, were conducted at doses of 50 to 400 mg, twice daily, of celecoxib in approximately 4,500 patients without initial ulceration. In 12 week endoscopic studies versus naproxen (1000 mg per day) and ibuprofen (2400 mg per day), celecoxib (100 to 800 mg per day) was associated with a significantly lower risk of peptic ulcers.
  • The data obtained in comparison with diclofenac (150 mg per day) were inconsistent. In two of the 12-week studies, the percentage of patients with peptic ulceration detected by endoscopy was not significantly different on placebo, celecoxib 200 mg twice daily and celecoxib 400 mg twice daily.
  • In a prospective long-term safety study (duration 6 to 15 months, CLASS study), 5,800 patients with osteoarthritis and 2,200 patients with rheumatoid arthritis received celecoxib 400 mg twice daily (i.e. four times and two times a day, respectively). times the recommended dosage for osteoarthritis and rheumatoid arthritis), ibuprofen 800 mg three times a day or diclofenac 75 mg twice a day (each in therapeutic doses). Twenty-two percent of the patients included were simultaneously taking low doses of acetylsalicylic acid (≤ 325 mg per day), mainly for CV prevention. Regarding the primary endpoint designated as complicated ulcers (defined as gastrointestinal bleeding, perforation, or obstruction), celecoxib was not significantly different from ibuprofen, nor from diclofenac individually. There was also no statistically significant difference in the combined NSAID group for complicated ulcers (relative risk 0.77; 95% CI 0.41 – 1.46; values ​​based on the entire duration of the study). For the mixed endpoint of complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group (relative risk 0.66; 95% CI 0.45 – 0.97), but not between celecoxib and diclofenac. Patients taking celecoxib and low doses of acetylsalicylic acid at the same time had 4-fold higher rates of complicated ulcers compared to those taking celecoxib alone. The incidence of clinically significant drops in hemoglobin (> 2 g / dl), confirmed by repeated dosing, was significantly less in patients receiving celecoxib compared to the NSAID group (relative risk 0.29; 95% CI 0, 17 – 0.48). The significantly lower incidence of this event with celecoxib was maintained with or without taking acetylsalicylic acid.
  • 0001). The rates of gastrointestinal complications with clinical manifestation such as perforation, obstruction or hemorrhage were very low and not different between treatment groups (4-5 per group).
  • Cardiovascular safety – Long-term studies in patients with sporadic adenomatous polyps.
  • Two studies evaluating celecoxib in subjects with sporadic adenomatous polyps were conducted: the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps).
  • In the APC trial, a dose-dependent increase in the composite endpoint combining CV death, myocardial infarction (MI) and Cerebral Vascular Accident (CVA) was observed with celecoxib compared to placebo over 3 years of treatment. The PreSAP trial did not show a statistically significant increase in risk for the same composite endpoint.
  • In the APC trial, the relative risk of death from CV, MI and stroke (composite endpoint) was 3.4 (95% CI 1.4-8.5) with 400 mg of celecoxib twice daily and 2.8 (95% CI 1.1-7.2) with 200 mg celecoxib twice daily compared to placebo. The cumulative values ​​for this composite endpoint over a 3-year period were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively compared to 0.9% (6/679 subjects) for the placebo. The increases observed compared to placebo for the two celecoxib dose groups were mainly due to an increased incidence of myocardial infarction.
  • In the PreSAP trial, the relative risk for this same composite endpoint was 1.2 (95% CI 0.6-2.4) with celecoxib 400 mg twice daily compared to placebo. The cumulative values ​​for this composite endpoint over a 3-year period were 2.3% (21/933 subjects) and 1.9% (12/628 subjects) for celecoxib and placebo, respectively. The incidence of myocardial infarction number was 1.0% (9/933 subjects) with a daily administration of 400 mg of celecoxib and 0.6% (4/628 subjects) with placebo.
  • Data from a third long-term study, ADAPT (The Alzheimer’s Disease Anti-inflammatory Prevention Trial) did not show a significant increase in CV risk with celecoxib 200 mg twice daily compared to placebo. The relative risk for a similar composite endpoint (CV death, myocardial infarction, stroke) was 1.14 (95% CI 0.61 – 2.15) with 200 mg celecoxib twice daily compared to placebo . The incidence of myocardial infarction was 1.1% (8/717 patients) with 200 mg celecoxib twice daily and 1.2% (13/1070 patients) with placebo.

A prospective randomized evaluation integrating the safety of celecoxib versus ibuprofen or naproxen (PRECISION study – Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen)

  • The PRECISION study is a double-blind study of cardiovascular safety in patients with osteoarthritis or rheumatoid arthritis at high risk of cardiovascular disease, comparing celecoxib (200 – 400 mg per day) with naproxen (750 – 1000 mg per day) and ibuprofen (1800 – 2400 mg per day). The primary endpoint, the Antiplatelet Trialists Collaboration (APTC), was a composite endpoint assessed independently of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke. The study was planned to have 80% power to assess non-inferiority. Of the’ Open-label esomeprazole (20 – 40 mg) has been prescribed to all patients for gastric protection. Patients on low dose aspirin were allowed to continue treatment; at baseline, nearly half of the subjects were taking aspirin. Secondary and tertiary endpoints included cardiovascular, gastrointestinal and renal outcomes. The mean administered dose was 209 ± 37 mg / day for celecoxib, 2045 ± 246 for ibuprofen and 852 ± 103 for naproxen.
  • For the primary endpoint, celecoxib compared to naproxen or ibuprofen met all four pre-established non-inferiority criteria, see Table 2.
  • Other independently assessed secondary and tertiary outcomes included cardiovascular, gastrointestinal, and renal outcomes. In addition, a four-month study investigating the effects of the three drugs on blood pressure, as measured by outpatient monitoring (ABPM), was conducted.

Table 2. Main analysis of the APTC composite endpoint evaluated

Analysis of the intent-to-treat (ITT – Intent to treat until 30 th month)
Celecoxib 100 – 200 mg twice daily Ibuprofen 600 – 800 mg three times a day Naproxen 375 – 500 mg twice daily
NOT 8,072 8,040 7 969
Subjects presenting events 188 (2.3%) 218 (2.7%) 201 (2.5%)
Pairwise comparison Celecoxib versus naproxen Celecoxib versus ibuprofen Ibuprofen versus naproxen
  RR (95% CI) 0.93 (0.76, 1.13) 0.8 6 ( 0.70  ; 1.0 4 ) 1, 08 (0, 89, 1, 31 )
Analysis of the population in modified intent to treat (MITT under treatment until 43 th month)
Celecoxib 100 – 200 mg twice daily Ibuprofen 600 – 800 mg three times a day Naproxen 375 – 500 mg twice daily
NOT 8,030 7 990 7 933
Subjects presenting events 134 (1.7%) 155 (1.9%) 144 (1.8%)
Pairwise comparison Celecoxib versus naproxen Celecoxib versus ibuprofen Ibuprofen versus naproxen
  RR (95% CI) 0.90 (0.72, 1.14) 0.81 (0.64, 1.02) 1, 12 (0, 889  ; 1, 40 )

Overall, the results were numerically similar in the celecoxib and comparator groups for the secondary and tertiary endpoints, and overall, no unexpected safety results were observed.

Overall, the PRECISION study shows that celecoxib at the lowest approved dose of 100 mg twice daily is not inferior to ibuprofen given at 600 mg to 800 mg three times daily or naproxen 375 mg to 500 mg twice daily for cardiovascular side effects. The cardiovascular risks of the NSAID class, including coxibs, are dose-dependent; therefore, results for celecoxib 200 mg per day on the composite cardiovascular endpoint cannot be extrapolated to dosing regimens using the higher doses of celecoxib.

How To Store Celecoxib Pfizer ?

  • Keep this medication out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date refers to the last day of that month.
  • Store at a temperature not exceeding + 30 ° C.
  • Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Celecoxib Pfizer Side Effects

Clarification
Adverse reactions reported at incidence rates greater than 0.01% and greater than those reported for placebo in 12 placebo-controlled clinical trials and standard treatment, conducted for up to 12 weeks in patients with d osteoarthritis and rheumatoid arthritis treated with daily doses of celecoxib of 100 mg to 800 mg. In additional studies using comparators such as non-selective NSAIDs, approximately 7,400 patients with OA were treated with celecoxib at daily doses up to 800 mg, of which approximately 2,300 patients were treated for 1 year or more. more. The side effects seen with celecoxib in these additional studies were consistent with those seen in patients withThe undesirable effects listed by organ class and classified by frequency in Table 1 correspond to the data presented in the following sources:

  • Adverse reactions reported at rates higher than placebo for subjects treated with celecoxib 400 mg daily for the long term testing, for a maximum of 3 years, in preventing polyps (Adenoma Prevention with Celecoxib trial (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP); see section Pharmacodynamic properties, Cardiovascular safety – Long-term studies in patients with sporadic adenomatous polyps).
  • Adverse reactions spontaneously reported after the marketing of the product over a period during which it is estimated that more than 70 million patients have been treated with celecoxib (various doses, durations and indications). Although these were identified as effects from post-marketing reports, trial data were consulted to estimate frequency. Frequencies are based on a cumulative meta-analysis pooling trials pooling exposure from 38,102 patients.

Table 1. Adverse reactions observed in clinical trials with celecoxib and during postmarketing surveillance (MedDRA terms) 1,2

Frequency of adverse reactions
System organ class Very frequent

(≥1 / 10)

Frequent

(≥1 / 100 to <1/10)

Infrequent

(≥1 / 1000 to <1/100)

Rare

(≥1 / 10,000 to <1 / 1,000)

Very rare

(<1 / 10,000)

Not known (frequency cannot be estimated from the available data)
Infections and infestations Sinusitis, upper respiratory tract infection, pharyngitis, urinary tract infection
Blood and lymphatic system disorders Anemia Leukopenia, thrombocytopenia Pancytopenia4
Immune system disorders Hypersensitivity Anaphylactic shock4, anaphylactic reaction4
Metabolism and nutrition disorders Hyperkalaemia
Psychiatric disorders Insomnia Anxiety, depression, fatigue Confusional state, hallucinations4
Nervous system disorders Dizziness, hypertonia, headache4 Cerebral infarction1, paresthesias, somnolence, Ataxia, dysgeusia Intracranial haemorrhage (including fatal intracranial haemorrhage) 4, aseptic meningitis4, epilepsy (including worsening epilepsy) 4, ageusia4, anosmia4
Eye disorders Blurred vision, conjunctivitis4 Eye bleeding4 Retinal artery occlusion4, retinal vein occlusion4
Ear and labyrinth disorders Tinnitus, hearing loss1
Cardiac disorders Myocardial infarction1 Heart failure, palpitations, tachycardia Arrhythmia4
Vascular disorders Hypertension1

(including worsening hypertension)

Pulmonary embolism4, flushing4 Vasculitis4
Respiratory, thoracic and mediastinal disorders Rhinitis, cough, dyspnea1 Bronchospasm4 Pneumonitis4
Gastrointestinal disorders Nausea4, abdominal pain, diarrhea, dyspepsia, gas, vomiting1, dysphagia1 Constipation, gastritis, stomatitis, gastrointestinal inflammation (including worsening gastrointestinal inflammation), belching Gastrointestinal bleeding4, duodenal ulcer, gastric ulcer, esophageal ulcer, intestinal ulcer, colon ulcer, intestinal perforation, esophagitis, melena, pancreatitis, colitis4
Hepatobiliary disorders Abnormal liver function, increased liver enzyme (including increased ALT and AST) Hepatitis4 Hepatic failure4 (sometimes fatal or requiring liver transplantation), fulminant hepatitis4, (sometimes fatal), hepatic necrosis4, cholestasis4, cholestatic hepatitis4, jaundice4
Skin and subcutaneous tissue disorders Rash, pruritus (includes generalized pruritus) Urticaria, bruising4 Angioedema4, alopecia, photosensitivity Exfoliative dermatitis4, erythema multiforme4, Stevens-Johnson syndrome4, toxic epidermal necrolysis4, drug reaction with eosinophilia and systemic symptoms (DRESS) 4, acute generalized exanthematous pustulosis (AGEP) 4, bullous dermatitis4
Musculoskeletal and connective tissue disorders Arthralgia4 Muscle contractures (lower limb cramps) Myositis4
Kidney and urinary tract disorders Blood creatinine increased, blood urea increased Acute renal failure4, hyponatremia4 Tubulointerstitial nephritis4, nephrotic syndrome4, minimal lesion glomerulonephritis4
Reproductive system and breast disorders Menstrual disorders4 Female infertility (decrease in fertility in women) 3
General disorders and administration site conditions Flu-like syndrome, peripheral edema / fluid retention Face edema, chest pain4
Injury, poisoning and procedural complications Injury ( accidental injury)
1 Adverse reactions occurring in polyp prevention studies in subjects treated with 400 mg celecoxib per day in two clinical trials of up to 3 years duration (APC and PreSAP trials). The adverse reactions listed above for polyp prevention trials are only those already identified during pharmacovigilance notifications or which occurred more frequently than in osteoarthritis trials.

² In addition, the following previously unknown adverse reactions occurred in polyps prevention studies involving subjects treated with 400 mg celecoxib per day in two clinical trials lasting up to 3 years (APC and PreSAP trials):

Common: angina pectoris, irritable bowel syndrome, nephrolithiasis, increased blood creatinine, benign prostatic hyperplasia, weight gain.

Uncommon: helicobacter infection, herpes zoster, erysipelas, bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous floaters, conjunctival hemorrhage, deep vein thrombosis, dysphonia, hemorrhoidal hemorrhage, frequent stools, mouth ulcers, ganglia, allergic ganglia , nocturia, vaginal haemorrhages, breast tenderness, lower limb fracture, increased sodium in the blood.

3 Women who wish to have a child are excluded from all studies. Therefore, consulting the study database to determine the frequency of this event was not valid.

4 Frequencies based on a cumulative meta-analysis pooling the trials grouping the exposure of 38,102 patients.

Evaluation of the final results of the APC and PreSAP trials (pooled data from the two trials; for the results of the individual trials, see section 5.1), for patients treated with 400 mg celecoxib per day for up to 3 years showed a increase in the number of myocardial infarctions of 7.6 events per 1000 patients (uncommon) compared to placebo; no increase in the number of strokes (undifferentiated types) was observed compared to placebo.

Celecoxib Pfizer Interactions

Pharmacodynamic interactions

Anti coagulants

  • Anticoagulant activity should be monitored in patients taking warfarin or similar products, especially in the first few days after initiating or modifying the dosage of celecoxib as these patients have an increased risk of bleeding complications. For this reason, the use of oral anticoagulants should be accompanied by close monitoring of the prothrombin INR level of patients, mainly during the first days after initiation of treatment with celecoxib or when the dosage of the drug is changed. celecoxib (see section Warnings and precautions for use). Bleeding, some with fatal outcome, associated with an increase in the prothrombin level and INR have been observed in patients, especially in the elderly,

Anti-hypertensives

  • NSAIDs may reduce the effects of antihypertensive drugs, including ACE inhibitors, angiotensin II receptor blockers, diuretics, and beta blockers. As with NSAIDs, the risk of acute renal failure, generally reversible, may be increased in certain patients with impaired renal function (for example: dehydrated patients , patients taking diuretics or elderly patients) when taking ACE inhibitors, angiotensin II receptor antagonists, and / or diuretics with NSAIDs, including celecoxib . Therefore, this combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter.
  • In a 28-day clinical study in patients with stage I and stage II hypertension controlled by lisinopril, administration of 200 mg celecoxib twice daily did not result in a clinical increase. significant systolic or diastolic blood pressure compared to placebo. Assessment was performed by ambulatory blood pressure monitoring for 24 hours. Among the patients treated with 200 mg celecoxib twice daily, 48% of them were considered non-responders to lisinopril at the final clinical visit compared to 27% of patients treated with placebo (were defined as non-responders, subjects whose diastolic blood pressure measured with a blood pressure monitor> 90 mmHg or whose

Ciclosporin and Tacrolimus

  • Co-administration of NSAIDs with ciclosporin or tacrolimus may increase the nephrotoxicity of ciclosporin or tacrolimus, respectively. Renal function should be monitored if celecoxib is combined with any of these drugs.

Acetylsalicylic acid

  • Celecoxib can be used in combination with a low dose of acetylsalicylic acid but cannot substitute for acetylsalicylic acid for CV prevention. In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications was demonstrated with the concomitant administration of low doses of acetylsalicylic acid, in comparison for the use of celecoxib alone.

Pharmacokinetic interactions

Effects of celecoxib on other drugs

CYP2D6 inhibition

  • Celecoxib is an inhibitor of cytochrome CYP2D6. The plasma concentrations of drugs which are substrates of this enzyme may be increased when combined with celecoxib. Drugs metabolized by CYP2D6 are, for example, antidepressants (tricyclics and selective serotonin reuptake inhibitors), neuroleptics, antiarrhythmics, etc. The dosage of CYP2D6 substrates, the dose of which is appropriate for each patient, may be reduced if necessary at the start of treatment with celecoxib or increased when stopping treatment with celecoxib.
  • Concomitant administration of 200 mg celecoxib twice daily resulted in 2.6-fold and 1.5-fold increased plasma concentrations of dextromethorphan and metoprolol (substrates of CYP2D6), respectively. These increases are due to the inhibition of the metabolism of CYP2D6 substrates by celecoxib.

CYP2C19 inhibition

  • In vitro studies have shown that celecoxib has the potential to inhibit the metabolism catalyzed by the cytochrome CYP2C19. The clinical significance of this in vitro observation is not known. Drugs metabolized by CYP2C19 are, for example, diazepam, citalopram and imipramine.

Methotrexate

  • In patients with rheumatoid arthritis, celecoxib has no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (at the doses used in rheumatology). However, adequate monitoring of methotrexate toxicity should be considered when combining these two drugs.

Lithium

  • In healthy subjects, the concomitant administration of 200 mg twice daily of celecoxib and 450 mg twice daily of lithium resulted in an average increase of 16% in Cmax and 18% in the area under the curve (AUC) of lithium. Therefore, patients treated with lithium should be closely monitored when initiating or stopping celecoxib.

Oral contraceptives

  • In an interaction study, celecoxib did not have clinically significant effects on the pharmacokinetics of oral contraceptives (1 mg norethisterone / 35 µg ethinyl estradiol).

Glibenclamide / Tolbutamide

  • Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate) or glibenclamide in a clinically meaningful way.

Effect of other drugs on celecoxib

CYP2C9 poor metabolisers

  • In subjects who are poor metabolizers of CYP2C9 with increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors, such as fluconazole, may further increase exposure to celecoxib. Such combinations should be avoided in known poor metabolisers of CYP2C9 .

CYP2C9 inhibitors and inducers

  • Since celecoxib is primarily metabolized by cytochrome CYP2C9, it should be used at half the recommended dose in patients treated with fluconazole. Concomitant use of a single 200 mg dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in Cmax of 60% and AUC of 130 % of celecoxib. Concomitant use with CYP2C9 inducers such as rifampicin, carbamazepine, or barbiturates may result in reduced plasma concentrations of celecoxib.

Ketoconazole and Antacids

  • No changes in the pharmacokinetics of celecoxib have been observed with ketoconazole or antacids.

Pediatric population

  • Interaction studies have only been performed in adults.

Effects on ability to Drive and use machines

  • You should be aware of the effects of CELECOXIB PFIZER on your body before driving or using machines. 
  • If you feel dizzy or drowsy after taking CELECOXIB PFIZER, do not drive or use machines until these effects have worn off.

Warnings and Precautions

Gastrointestinal (GI) effects

  • Upper and lower gastrointestinal complications (perforations, ulcers or hemorrhages [PUH]), some with fatal outcome, have been observed in patients treated with celecoxib.
  • Caution should be exercised in patients at greatest risk of developing a gastrointestinal complication with NSAIDs:
    • The elderly,
    •  The patients using other NSAIDs, or antiplatelet drugs (such as acetylsalicylic acid), or by concomitant glucocorticoids,
    • Patients who consume alcohol,
    • or patients with a history of gastrointestinal illness such as ulcer and bleeding.
  • There is an increased risk of gastrointestinal side effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is used in combination with acetylsalicylic acid (even at low doses). A significant difference in gastrointestinal tolerance between the combination of selective COX-2 inhibitors and acetylsalicylic acid compared to the combination of NSAIDs and acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section Pharmacodynamic properties).

Concomitant use of NSAIDs

  • Concomitant use of celecoxib and an NSAID other than aspirin should be avoided.

Cardiovascular effects

  • In comparison to placebo, an increase in the number of serious cardiovascular (CV) events, mainly myocardial infarctions, was observed in a long-term study in patients with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg twice daily and 400 mg twice daily.
  • Due to the possible increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this medication should be prescribed at the minimum effective daily dose for the shortest possible time. NSAIDs, including selective COX-2 inhibitors, have been associated with an increased risk of cardiovascular and thrombotic adverse events when taken long term. The exact magnitude of the risk associated with a single dose has not been determined, nor the exact duration of treatment associated with an increased risk.
  • The need for symptomatic treatment and its therapeutic efficacy for the patient should be reassessed periodically, in particular in patients with osteoarthritis (Contraindications, Adverse reactions and Pharmacodynamic properties).
  • Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes, smoking) should be treated with celecoxib only after careful evaluation.
  • Due to their lack of anti-platelet effects, selective COX-2 inhibitors cannot substitute for acetylsalicylic acid in the prevention of cardiovascular thromboembolic diseases. Therefore, antiplatelet therapy should not be stopped.

Fluid retention and edema

  • As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in patients treated with celecoxib. Therefore celecoxib should be administered with caution in patients with a history of heart failure, left ventricular dysfunction or arterial hypertension and in patients with pre-existing edema regardless of its origin because the inhibition of prostaglandins can lead to deterioration of kidney function and fluid retention. Precautions will also be necessary in patients treated with diuretics or at risk of hypovolaemia.

Hypertension

  • Like all NSAIDs, celecoxib can cause hypertension or worsen pre-existing hypertension, thus increasing the incidence of cardiovascular events. Close monitoring of blood pressure at the start of treatment with celecoxib and then during treatment should therefore be carried out.

Renal and hepatic effects

  • The existence of impaired renal or hepatic function, and particularly cardiac dysfunction, is more likely in the elderly. Therefore, appropriate medical surveillance should be ensured.
  • NSAIDs, including celecoxib, may be responsible for renal toxicity. Clinical trials with celecoxib have shown renal effects similar to those seen with comparator NSAIDs. Patients most at risk of developing renal toxicity are patients with renal failure, heart failure, liver problems, those taking diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists as well as the elderly (see section Interactions with other medicinal products and other forms of interactions). These patients should be closely monitored while receiving celecoxib therapy.
  • A few cases of serious hepatic reactions have been reported with celecoxib, including fulminant hepatitis (some fatal), hepatic necrosis and hepatic failure (some fatal or requiring liver transplantation). In cases for which time to onset was reported, most serious hepatic reactions occurred within one month of starting treatment.
  • During treatment, appropriate measures will be taken and discontinuation of celecoxib treatment should be considered if there is any functional deterioration of the above mentioned organs.

CYP2D6 inhibition

  • Celecoxib inhibits CYP2D6. Even though it is not a strong inhibitor of this enzyme, a dosage reduction may be necessary for medicines whose dose is adjusted for each patient and which are metabolized by CYP2D6.

CYP2C9 poor metabolisers

  • Patients known to be poor metabolisers of CYP2C9 should be treated with caution.

Skin reactions and systemic hypersensitivity reactions

  • Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), have been very rarely reported in association with the use of celecoxib (see section Side effects).
  • The risk of these effects occurring seems to be greatest at the start of treatment, the onset of these effects occurring in the majority of cases during the first month of treatment. Serious hypersensitivity reactions (including anaphylaxis, angioedema, and drug-induced rash with eosinophilia and systemic symptoms (DRESS), or hypersensitivity syndrome) have been reported in patients receiving celecoxib.
  • Patients with a history of allergy to sulfonamides or to any other medication may be at increased risk of serious skin reactions or hypersensitivity.
  • Celecoxib should be stopped at the first sign of skin rash, mucosal damage, or any other sign of hypersensitivity.

General effects

  • Celecoxib may mask fever and other signs of inflammation.

Use with oral anticoagulants

  • In patients treated with warfarin, severe bleeding, some with fatal outcome, has been reported. An increased prothrombin time (INR) has been reported with concomitant treatments. It should therefore be closely monitored in patients receiving warfarin / oral coumarin-type anticoagulants, particularly when initiating therapy with celecoxib or when the dose of celecoxib is changed (see section 4.5). and other forms of interactions). The concomitant use of anticoagulants and NSAIDs may increase the risk of bleeding. Caution should be exercised when co-administering celecoxib with warfarin or other oral anticoagulants.

Excipients

  • CELECOXIB PFIZER 100 mg hard capsules contain lactose (149.7 mg). Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

  • Studies in animals (rats and rabbits) have demonstrated toxicity on the reproductive functions including malformations (see sections Contraindications and Preclinical safety data). Inhibition of prostaglandin synthesis could have a deleterious effect on pregnancy.
  • Data from epidemiological studies point to an increased risk of spontaneous miscarriages after the use of prostaglandin synthesis inhibitors in early pregnancy.
  • In humans, the risk during pregnancy is unknown but cannot be excluded. Like other drugs that inhibit prostaglandin synthesis, celecoxib can cause uterine inertia and premature closure of the ductus arteriosus in the last trimester of pregnancy.
  • During the second or third trimester of pregnancy, NSAIDs including celecoxib can cause fetal renal dysfunction which may result in reduced amniotic fluid volume or oligoamnion in severe cases. Such effects can appear quickly after initiation of treatment and are usually reversible.
  • Celecoxib is contraindicated during pregnancy and in women of childbearing potential (see sections Contraindications and Warnings and precautions for use). If pregnancy is discovered during treatment, celecoxib should be stopped.

Feeding with milk

  • Celecoxib is excreted in the milk of rats at concentrations similar to those found in plasma. Administration of celecoxib to a small number of breastfeeding women has shown very little passage of celecoxib into breast milk. Patients treated with CELECOXIB PFIZER should not breast-feed.

Fertility

  • Due to their mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women.

What happens if I overdose from Celecoxib Pfizer ?

If you take more CELECOXIB PFIZER 100 mg, capsule than you should:

Do not take more capsules than your doctor has prescribed. If you take more capsules, consult your doctor, pharmacist or hospital immediately and take your medicine with you.

What should I do if I miss a dose?

If you forgot to take a capsule, take it as soon as you remember. Do not take a double dose to make up for the single dose you forgot to take.

What happens if you stop taking Celecoxib Pfizer ?

If you stop taking CELECOXIB PFIZER 100 mg capsule:

  • Suddenly stopping your treatment with CELECOXIB PFIZER may cause your symptoms to get worse. Do not stop taking CELECOXIB PFIZER unless your doctor tells you to. Your doctor may advise you to reduce the dose for a few days before stopping treatment permanently.
  • If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is  Forms and Composition ?

Appearance and shape

  • Capsule.
  • White and opaque hard capsules with two blue bands indicating 7767 and 100 respectively.
  • Blisters (transparent or opaque PVC / Aluminum) of 2, 5, 6, 10, 20, 30, 40, 50, 50 (1×50 unit doses), 60, 100, 100 (10×10), 100 (1×100 unit doses), 300 (10×30), 500 (10×50) and 500 (5 x (10×10)) capsules.
  • Not all presentations may be marketed.

Composition

Active ingredient Capsule
Celecoxib 100 mg *

* per unit dose

Active ingredients: Celecoxib

Excipients with known effects ?

  • Capsule contents: Lactose monohydrate, Propylene glycol
Other excipients: 
Sodium lauryl sulphate, Povidone, Croscarmellose sodium, Magnesium stearate, Capsule shell: Gelatin, Titanium dioxide, Sodium laurylsulfate , Sorbitan laurate, Printing ink: Indigotine, Shellac

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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CARTREX 100 mg Uses, Dosage, Side Effects, Precautions & Warnings https://edrug-online.com/1439/cartrex.html https://edrug-online.com/1439/cartrex.html#respond Thu, 17 Sep 2020 08:57:34 +0000 https://edrug-online.com/?p=1439 cartrex medicamentGeneric drug of the Therapeutic class: Anti-inflammatory active ingredients: Aceclofenac what is CARTREX? This medication is a nonsteroidal anti-inflammatory drug. It is indicated in adults and children from 15 years of age in the treatment of arthritis attacks and the treatment of certain inflammatory rheumatism. what is CARTREX medication used for and indication? Pharmacotherapeutic group: anti-inflammatory / anti-rheumatic drugs, non-steroidal […]]]> cartrex medicament

Generic drug of the Therapeutic class: Anti-inflammatory
active ingredients: Aceclofenac

what is CARTREX?

This medication is a nonsteroidal anti-inflammatory drug. It is indicated in adults and children from 15 years of age in the treatment of arthritis attacks and the treatment of certain inflammatory rheumatism.

what is CARTREX medication used for and indication?

Pharmacotherapeutic group: anti-inflammatory / anti-rheumatic drugs, non-steroidal – ATC code:

  • M01AB16.
  • CARTREX is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs have anti-inflammatory and analgesic properties. The active substance in CARTREX 100 mg film-coated tablets is eclofenac.
  • CARTREX is used to relieve pain and inflammation if you have different types of joint inflammation (joint diseases such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis).

CARTREX Dosage

Oral route.

  • The tablets are to be swallowed whole with at least half a glass of water or other liquid. CARTREX can be taken with food.

Adults

  • The maximum recommended dose is 200 mg per day in two divided doses, i.e. one 100 mg tablet in the morning and evening.

Older subjects

  • In general, it is not necessary to reduce the dosage; however, precautions should be taken (see section Warnings and precautions for use ).

Children

  • The safety and efficacy of the product have not been demonstrated in children and adolescents.

Hepatic impairment

  • In case of mild to moderate hepatic impairment, the dosage will be reduced. The recommended starting dose is 100 mg per day.

Kidney failure

  • In the event of mild renal insufficiency, it is not necessary to reduce the dosage; however, precautions must be taken.
  • The occurrence of side effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary for the relief of symptom.

Contraindications

  • History of asthma attack, bronchospasm, acute rhinitis or hives triggered by NSAIDs or aspirin
  • Progressive peptic ulcer
  • History of peptic ulcer or recurrent gastrointestinal bleeding
  • Hemorrhage
  • History of hemorrhage or digestive perforation by NSAIDs
  • NYHA Class II-IV Heart Failure
  • Ischemic heart disease
  • Peripheral arterial disease
  • Cerebrovascular disease
  • Severe hepatic impairment
  • Severe renal failure
  • 3rd trimester pregnancy
  • Child under 6
  • Varicella
  • Pregnancy 1st trimester
  • 2nd trimester pregnancy
  • Feeding with milk
  • Woman who wishes to conceive
  • Reduced female fertility
  • Woman’s fertility check-up

Aceclofenac is contraindicated in the following situations:

Hypersensitivity to aceclofenac or to one of the excipients mentioned in the Composition section or hypersensitivity to molecules of similar activity such as other NSAIDs, aspirin,

– Patients in whom taking aspirin or other NSAIDs may trigger an asthma attack, bronchospasm, acute rhinitis or hives,

Progressive peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified),

Gastrointestinal bleeding or any other type of bleeding,

– History of bleeding or perforation of the digestive system during previous treatment with NSAIDs,

Known congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease,

Severe hepatic or renal insufficiency,

– During the last three months of pregnancy (see section Fertility, pregnancy and breast-feeding).

HOW TO TAKE CARTREX?

  • Be sure to always take this medicine exactly as your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
  • Your doctor will prescribe the lowest effective dose for the shortest time possible to reduce side effects.
  • Do not exceed the recommended daily dose.
  • Adults: The recommended dose is 200 mg (2 tablets). One 100 mg tablet should be taken in the morning and another 100 mg tablet in the evening.
  • In patients with hepatic impairment, the recommended starting dose is 100 mg.
  • The tablets should be swallowed as is with a glass of water and can be taken with food.

If you take more CARTREX 100 mg film-coated tablet than you should

  • If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital for the emergency department. Please take this leaflet and the CARTREX box with you so that the doctor will know what you have taken.
  • Symptoms of overdose may include nausea, vomiting, stomach pain, dizziness, drowsiness, and headache.
  • If you forget to take CARTREX 100 mg film-coated tablet
  • If you miss a dose, don’t worry, just take the next dose at the usual time. Do not take a double dose to make up for the dose you forgot to take.
  • If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

If you stop taking CARTREX 100 mg film-coated tablets

  • Not applicable.

If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

How it works ?

Absorption

  • After oral administration, aceclofenac is rapidly absorbed and its bioavailability reaches almost 100%. Maximum plasma concentrations are reached approximately 1.25 to 3 hours after ingestion. The simultaneous intake of food delays the Tmax while the absorption is not influenced.

Distribution

  • Aceclofenac is highly protein bound (> 99.7%).
  • It enters the synovial fluid where its concentration reaches about 60% of the plasma concentration.
  • The volume of distribution is approximately 30 liters.

Elimination

  • The mean plasma elimination half-life is 4-4.3 hours. The clearance is estimated at 5 liters per hour. About two thirds of the administered dose is excreted in the urine, mainly in the form of hydroxymetabolites. After a single oral dose, only 1% is excreted unchanged.
  • Aceclofenac is probably metabolized via CYP2C9 to its major metabolite
    4′-OH-aceclofenac, the clinical activity of which is probably negligible. Among all the metabolites, diclofenac and 4′-OH-diclofenac have been detected.

Characteristics in some patients:

  • No change in the pharmacokinetics of aceclofenac has been demonstrated in the elderly.
  • Slowing of the elimination of the product has been observed in the event of impaired hepatic function, after administration of a single dose of aceclofenac.
  • A repeated dose study of 100 mg per day shows that the pharmacokinetic parameters are not changed between healthy subjects and subjects with mild to moderate hepatic impairment.
  • Likewise in patients with mild to moderate renal impairment, there is no clinically significant difference in pharmacokinetic parameters after administration of a single dose of aceclofenac.

HOW TO STORE CARTREX?

  • Keep this medication out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and the blister pack after “EXP”. The expiration date refers to the last day of that month.
  • Store at a temperature not exceeding 30 ° C.
  • Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

CARTREX Side Effects

Like all medicines, CARTREX 100 mg film-coated tablets can cause side effects, although not everybody gets them.

  • Allergic skin reactions may occur: rash on the skin, itching, inflammation of the skin, or general: facial edema, allergic shock.
  • Exceptional serious skin infections in chickenpox.
  • In rare cases, it is possible that digestive bleeding occurs. This is all the more frequent the higher the dosage used.
  • Medicines such as CARTREX may increase the risk of a heart attack (“myocardial infarction”) or stroke.

In all cases, the treatment should be stopped immediately and your doctor should be notified.

During treatment, it is possible that:

  • digestive disorders: difficult digestion, abdominal pain, nausea, vomiting, diarrhea, constipation, bloating,
  • dizziness, headache, fatigue, tremors, ringing in the ears,
  • disorders of mood, sensitivity, vision and taste, sleep,
  • weight gain, edema, hypertension,
  • palpitations, cramps, flushing of the face, eczema, discomfort or difficulty in breathing,
  • inflammation of the mouth.

In all cases, you should notify your doctor.

  • Cases of inflammation of the stomach, pancreas, liver or blood vessels, as well as digestive ulcerations, kidney damage may occur.
  • A few rare cases of biological changes may eventually necessitate a check-up of blood, liver and kidney tests.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

CARTREX Interactions

No pharmacokinetic interaction studies (except with warfarin) have been performed.

Aceclofenac is metabolized via cytochrome P450 2C9 and in vitro data indicate that aceclofenac may be an inhibitor of this enzyme. There is therefore a risk of pharmacokinetic interaction with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole.

As with other NSAIDs, there is a risk of pharmacokinetic interaction with drugs with active renal elimination, such as methotrexate and lithium.

Aceclofenac is almost completely bound to plasma proteins (Albumin). The possibility of interaction with drugs strongly bound to plasma proteins should be taken into account.

Due to the lack of pharmacokinetic interaction study the following recommendations are based on information with other NSAIDs:

Not recommended associations

Methotrexate (high doses)

  • NSAIDs inhibit its tubular secretion. A slight metabolic interaction by reduced clearance of methotrexate can be observed.
  • Therefore, the prescription of NSAIDs should always be avoided during treatment with high dose methotrexate.

Lithium and digoxin

  • Several NSAIDs inhibit renal clearance of lithium and digoxin, thereby increasing their serum concentrations.
  • If the combination cannot be avoided, increased monitoring of lithium or digoxin levels should be performed.

Corticosteroids

  • Increased risk of gastrointestinal ulceration and bleeding.

Anticoagulants

  • NSAIDs may enhance the effects of anticoagulants, such as warfarin . For patients combining treatment with anticoagulants and aceclofenac, close monitoring should be undertaken.

 Antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs)

  • Increased risk of gastrointestinal bleeding.

Interactions requiring dose adjustments or precautions for use

Methotrexate (low doses)

  • A possible interaction between an NSAID and methotrexate even when used at low doses should be considered, especially in patients with reduced renal function.
  • If the combination cannot be avoided within the same 24 hour period, renal function should be monitored due to the increase in methotrexate levels which can reach toxic values.

Ciclosporin and tacrolimus

The combination of an NSAID with ciclosporin or tacrolimus increases the risk of nephrotoxicity, due to the decrease in the synthesis of renal prostacyclins.

In case of combination, it is important to control renal function.

+ Other NSAIDs including aspirin (> 3 g per day) and corticosteroids: the combination with other NSAIDs including aspirin and corticosteroids may increase the frequency of side effects; caution is therefore required.

+ Diuretics, ACE inhibitors, angiotensin II antagonists: NSAIDs may reduce the effects of diuretics and other antihypertensive drugs.

  • In some patients with impaired renal function (for example dehydrated patients or some elderly patients), the combination of an angiotensin converting enzyme inhibitor or angiotensin II receptor blocker with treatments that inhibit cyclooxygenase may cause further deterioration of kidney function, including acute kidney failure, which is usually reversible. Therefore, any such combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered when initiating concomitant therapy and then at regular intervals.
  • Concomitant administration with potassium diuretics may be accompanied by an increase in serum potassium concentration. The latter must then be monitored.
  • When co-administered with bendrofluazide, aceclofenac would not affect blood pressure; however an interaction with antihypertensive drugs cannot be excluded.

Other possible interactions

  • Anti-diabetic treatments : In clinical studies it has been shown that diclofenac can be administered in combination with oral anti-diabetics without influencing their clinical efficacy. However, isolated cases of hypoglycemia and hyperglycemia have been reported with aceclofenac. The doses of drugs that may cause hypoglycemia should therefore be adjusted in combination with aceclofenac.
  • Zidovudine : increased risk of haematological toxicity in the event of treatment combining NSAIDs and zidovudine. An increased risk of hemato-arthrosis and hematomas has been shown in HIV (+) hemophiliacs receiving simultaneous treatment with zidovudine and ibuprofen.

Drive and use machines

If you experience dizziness, vertigo, or other central nervous system adverse effects while taking NSAIDs, you should not drive or use machinery.

Warnings and Precautions

Special warnings

THIS MEDICINE SHOULD ONLY BE TAKEN UNDER MEDICAL SUPERVISION

  • NSAIDs such as CARTREX may increase the risk of a heart attack (“myocardial infarction”) or stroke. The risk is all the greater as the doses used are high and the duration of treatment prolonged.
  • Do not exceed the recommended doses or the duration of treatment.
  • If you have heart problems, if you have had a stroke or if you think you have risk factors for this type of pathology (for example in case of high blood pressure, diabetes, high cholesterol level) or if you smoke, talk to your doctor or pharmacist.
  • In chickenpox, the use of this medication is not recommended due to exceptional serious skin infections.

BEFORE USING A NON-STEROID ANTI-INFLAMMATORY ANTI-INFLAMMATORY, ADVISE YOUR DOCTOR in the event of:

  • coagulation disorders, concomitant anticoagulant therapy. This medicine can cause serious gastrointestinal symptoms,
  • digestive history,
  • heart, liver or kidney disease,
  • treatment with diuretics, recent surgery,
  • treatment with oral corticosteroids, anticoagulants, antidepressants such as serotonin reuptake inhibitors or antiplatelet agents,
  • porphyria (hereditary disease),
  • systemic lupus erythematosus.

DURING TREATMENT WITH A NON-STEROID ANTI-INFLAMMATORY ANTI-INFLAMMATORY, STOP THE TREATMENT AND IMMEDIATELY CONTACT A DOCTOR OR AN EMERGENCY MEDICAL SERVICE in the event of:

  • signs suggestive of allergy to this medication, in particular asthma attack, hives, sudden swelling of the face, peeling of the skin and / or mucous membranes,
  • gastrointestinal bleeding (discharge of blood from the mouth, blood in the stools, or stool staining black).

THIS MEDICINAL PRODUCT CONTAINS A NON-STEROID ANTI-INFLAMMATORY: ACECLOFENAC.

You should not take other medicines containing nonsteroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and / or aspirin at the same time as this medicine.

Carefully read the package leaflets for other medicines you are taking to make sure you are free from NSAIDs and / or aspirin.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

  • There are no data from the use of aceclofenac in pregnant women. But in general, prostaglandin synthesis inhibitors can affect pregnancy and / or embryofoetal development. Data from epidemiological studies show an increased risk of spontaneous abortion, heart malformation and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of a heart defect increases from less than 1% to about 1.5%. This risk seems to increase with the dose and the duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has been shown to be associated with pre- and post-implantation loss and embryo-fetal lethality.
  • In addition, an increased incidence of various malformations (eg cardiovascular) has been reported in animals receiving prostaglandin synthesis inhibitors during organogenesis. During the 1st and 2nd trimesters of pregnancy, NSAIDs should only be administered in cases of clearly identified need. In the event that NSAIDs are administered to a woman wishing to become pregnant or during the 1st and 2nd trimesters of pregnancy, the doses and duration of treatment should be as low as possible.

During the 3rd trimester of pregnancy, administration of prostaglandin synthesis inhibitors exposes the fetus to:

  • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
  • Renal dysfunction which may progress to renal failure with oligo-hydroamnios.

Administration of prostaglandin synthesis inhibitors at the end of pregnancy exposes the mother and the unborn child to:

  • A possible prolongation of the bleeding, an antiplatelet effect which can occur even at low doses;
  • An inhibition of uterine contractions resulting in delay and prolongation of labor.
  • Therefore, NSAIDs are contraindicated during the 3rd trimester of pregnancy (see section Contraindications).

Feeding with milk

  • There are no data regarding the excretion of aceclofenac in human milk.
  • However, no significant transfer of radiolabeled (14C) aceclofenac was observed in the milk of lactating female rats.
  • Therefore, continued breast-feeding or treatment with CARTREX should be considered taking into account the expected benefit of breast-feeding for the child and the expected benefit of the treatment for the mother.

Fertility

  • The use of CARTREX, like any medicine which inhibits the synthesis of cyclo-oxygenases / prostaglandins, may decrease fertility and is not recommended in women trying to have a child. Consideration should be given to stopping CARTREX in women who have difficulty becoming pregnant or attending infertility.

What happens if I overdose from CARTREX ?

  • There are insufficient data available on the consequences of overdose in humans. Symptoms could be: nausea, vomiting, stomach pain, dizziness, drowsiness and headache.
  • Treatment of NSAID overdose consists of, if necessary, the use of antacids and other symptomatic treatments for complications such as hypotension, renal failure, seizures, gastrointestinal irritation, and respiratory depression.
  • Treatment of an overdose with aceclofenac consists of stopping absorption by gastric lavage and repeated administrations of activated charcoal.
  • Forced diuresis, dialysis or hemoperfusion may fail to eliminate NSAIDs, due to their strong binding to plasma proteins and extensive metabolism.

What should I do if I miss a dose?

Do not take a double dose to make up for the dose you forgot to take.

What is  Forms and Composition ?

SHAPES and PRESENTATIONS
  • 100 mg film-coated tablet (round; 8 mm in diameter; white):   Box of 30, in blisters.
COMPOSITION
  p cp
Aceclofenac 100 mg
  • Excipients: microcrystalline cellulose, croscarmellose sodium, povidone, glycerol palmitostearate. Film- coating : hypromellose, macrogol 40 stearate, titanium dioxide (E 171), microcrystalline cellulose (Sepifilm 752 white).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Celebrex Capsule Uses, Dosage, Side Effects, Precautions https://edrug-online.com/84/celebrex-capsule.html https://edrug-online.com/84/celebrex-capsule.html#comments Sat, 22 Aug 2020 16:38:09 +0000 http://www.edrug-online.com/?p=84 Celebrex (Celecoxib) Capsule Uses, Dosage, Side Effects, PrecautionsGeneric drug of the therapeutic class: Anti-inflammatory active ingredients: Celecoxib. what is celebrex ? Celecoxib stagnates pain, inhibits inflammation and lowers fever. For joint pain , rheumatoid arthritis and Bechterew’s disease. Sometimes also used in other types of pain, such as osteoarthritis (worn joints) or menstrual pain. The pain is reduced 1 to 2 hours after ingestion . The operation lasts for 12 to 24 hours. Inflammation reduces redness and swelling within one […]]]> Celebrex (Celecoxib) Capsule Uses, Dosage, Side Effects, Precautions

Generic drug of the therapeutic class: Anti-inflammatory
active ingredients: Celecoxib.

what is celebrex ?

  • Celecoxib stagnates pain, inhibits inflammation and lowers fever.
  • For joint pain , rheumatoid arthritis and Bechterew’s disease. Sometimes also used in other types of pain, such as osteoarthritis (worn joints) or menstrual pain.
  • The pain is reduced 1 to 2 hours after ingestion . The operation lasts for 12 to 24 hours. Inflammation reduces redness and swelling within one to two weeks.
  • Note: chances of gastrointestinal ulcers and bleeding. Are you over 70 years old, have you had a stomach or intestinal ulcer before, or do you use anti-coagulation medication? Then you need a stomach protector . Ask your doctor or pharmacist about this
  • Watch out with alcohol. Alcohol increases the risk of stomach problems.
  • Many interactions with other medicines. Ask your pharmacist if you can safely use celecoxib with your other medicines, including medicines that you have bought without a prescription.

what is celebrex used for and indication?

  • Celebrex (Celecoxib) Capsule is indicated in adults for the relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis (RA) and ankylosing spondylitis (AS).
  • The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on the assessment of all risks specific to each patient (see sections Contraindications and Warnings and Precautions). employment ).

what is celebrex dosage?

celebrex dosage

  • Due to the potential increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this drug should be prescribed at the lowest effective daily dose for the shortest period possible.
  • The need for symptomatic treatment and its therapeutic efficacy for the patient should be re-evaluated periodically, especially in patients with osteoarthritis (see sections Contraindications , Warnings and Precautions for Use , Adverse Reactions and Pharmacodynamic Properties ).

osteoarthritis

  • The recommended daily dose is 200 mg divided into one or two doses.
  • In some patients whose symptoms are insufficiently relieved, increasing the dose to 200 mg twice daily may increase efficacy.
  • In the absence of improvement in therapeutic benefit after 2 weeks, other therapeutic options should be considered.

Rheumatoid arthritis

  • The recommended initial daily dose is 200 mg divided into 2 doses.
  • If necessary, the dose may be increased later to 200 mg twice daily. In the absence of improvement in therapeutic benefit after 2 weeks, other therapeutic options should be considered.

Ankylosing spondylitis 

  • The recommended daily dose is 200 mg divided into one or two doses.
  • For a small number of patients whose symptoms are not sufficiently relieved, increasing the dose to 400 mg divided into one or two doses may increase efficacy.
  • In the absence of improvement in therapeutic benefit after 2 weeks, other therapeutic options should be considered.
  • The maximum recommended daily dose for all indications is 400 mg.

Special populations

celebrex dosage for elderly

Elderly (> 65 years old)

  • As with any patient, treatment will be started at 200 mg daily.
  • If necessary, the dose may be increased later to 200 mg twice daily. Special attention should be paid to elderly subjects with body weight below 50 kg (see Warnings and Precautions   and Pharmacokinetic Properties sections ).

Pediatric populations

CYP2C9 slow metabolizers

  • Since the risk of dose-related adverse events is higher, celecoxib should be given with caution to patients known or suspected to be poor metabolisers of CYP2C9, based on genotyping or previous history / experience with other substrates. of CYP2C9.
  • A reduction in the dose to half the lowest recommended dose should be considered ( Pharmacokinetic properties ).

Patients with hepatic impairment

  • In patients with moderate hepatic impairment with serum albumin of 25-35 g / l, treatment should be initiated at half the recommended dose.
  • The experience in this type of patients is limited to that of cirrhotic patients (see sections Contraindications , Warnings and Precautions   and Pharmacokinetic Properties ).

Patients with renal insufficiency

  • Since the experience with celecoxib in patients with mild to moderate renal impairment is limited, these patients should be treated with caution (see sections Contraindications , Warnings and Precautions and Pharmacokinetic Properties ).

Administration mode

Oral way

Celebrex (Celecoxib) Capsule can be taken during or outside meals. Patients who have difficulty swallowing capsules may add the content of the celecoxib capsule to applesauce, rice pudding, yoghurt or banana puree. For this, the entire contents of the capsule should be carefully emptied in a teaspoon of applesauce, rice pudding, yoghurt or banana puree, cold or at room temperature, and be ingested immediately with 240 ml of water. Once sprinkled on applesauce, rice pudding or yoghurt, the capsule content remains stable for 6 hours in the refrigerator (between 2 and 8 ° C). If the contents of the capsule are sprinkled on banana puree, it should not be refrigerated and should be ingested immediately.

Celebrex (Celecoxib) Capsule Dosage
Celebrex (Celecoxib) Capsule Dosage

Contraindications

  • History of hypersensitivity to the active ingredient or to one of the excipients (see composition section).
  • Known hypersensitivity to sulfonamides.
  • Active peptic ulcer or gastrointestinal (GI) bleeding.
  •  History of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions triggered by taking acetylsalicylic acid or NSAIDs, including COX inhibitors- 2 (cyclooxygenase-2).
  • Severe hepatic impairment (serum albumin <25 g / L or Child-Pugh score> = 10).
  • Patients with estimated creatinine clearance <30 ml / min.
  • Inflammatory bowel disease.
  • Congestive heart failure (NYHA II-IV).
  • Known ischemic heart disease, peripheral arterial disease and / or history of stroke (including transient ischemic attack).
  • Pregnancy and women of childbearing age, in the absence of effective contraception. In the two animal species studied, celecoxib caused malformations. In humans, the risk during pregnancy is not known but cannot be excluded: there are no clinical data on pregnancies exposed to celecoxib. Studies carried out in animals (rats and rabbits) have shown toxicity on reproductive functions including malformations. In humans, the risk during pregnancy is unknown but cannot be excluded. Like other drugs that inhibit prostaglandin synthesis, celecoxib can cause uterine inertia and premature closure of the ductus arteriosus in the last trimester of pregnancy. Celecoxib is contraindicated during pregnancy and in women who may become pregnant. If pregnancy is discovered during treatment, celecoxib should be stopped.
  • Breast-feeding: there are no studies on the passage of celecoxib into human breast milk. Celecoxib is excreted in the milk of rats at concentrations similar to those found in plasma. Patients on celecoxib should not breast-feed.
  • CELEBREX 100 mg hard capsules contain lactose (149.7 mg). Due to the presence of lactose, this medication should not be administered in patients with congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
  • Children: celecoxib is not indicated in children.

how celebrex works in the body?

Pharmacotherapeutic group: non-steroidal anti-inflammatory, antirheumatic, NSAID, Coxibs. ATC Code: M01AH01.

Mechanisms of action

  • Celecoxib is a selective oral cyclooxygenase-2 (COX-2) inhibitor at clinical doses (200 mg to 400 mg daily). No statistically significant inhibition of COX-1 evaluated by ex-vivo inhibition of thromboxane B2 (TxB2) formation was observed at these doses in healthy volunteers.

Pharmacodynamic effects

  • Cyclooxygenase is responsible for the synthesis of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. Cyclooxygenase-2 (COX-2) is the isoform of the enzyme induced by pro-inflammatory stimuli and is believed to be the main culprit in the synthesis of prostanoid mediators of pain, inflammation and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and some CNS functions (fever induction, pain perception, and cognitive function). It could also play a role in the healing of ulcers. COX-2 has been shown in tissues around gastric ulcers in humans but its involvement in the healing of ulcers
  • The difference in anti-platelet activity between some COX-1 inhibitory NSAIDs and the selective COX-2 inhibitors may be of clinical significance in patients at risk for thromboembolic reactions. Selective COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin, without altering platelet thromboxane.
  • Celecoxib is a pyrazole derivative substituted with two aryl groups, a chemical analogue of other non-arylamine sulfonamides (eg thiazides, furosemide) but it differs from arylamine sulfamides (eg, sulfamethoxazole and other sulfonamide antibiotics).
  • A dose-dependent effect on TxB2 formation was observed after high doses of celecoxib. However, in healthy subjects and in low-dose, multiple dose studies with 600 mg twice daily (equivalent to three times the highest recommended dose), celecoxib had no effect on platelet aggregation, neither on bleeding time compared to placebo.

Efficacy and clinical safety

  • Several clinical trials confirming the efficacy and safety of celecoxib in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis have been performed. Celecoxib was evaluated for 12 weeks in the treatment of inflammation and pain of osteoarthritis of the knee and hip in approximately 4200 patients in placebo-controlled trials and reference products. It was also evaluated for 24 weeks in the treatment of inflammation and pain of rheumatoid arthritis in approximately 2100 patients in placebo-controlled trials and reference products. Celecoxib at a daily dose of 200 mg to 400 mg relieved pain within 24 hours of administration. Celecoxib was evaluated for 12 weeks in the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo-controlled trials and reference products. In these trials celecoxib, at doses of 100 mg twice daily, 200 mg once daily, 200 mg twice daily and 400 mg once daily, demonstrated significant improvement in pain, index overall activity of disease and function in ankylosing spondylitis.
  • Five randomized, double-blind controlled trials, including endoscopy of the upper gastrointestinal tract, were conducted at doses of 50-400 mg, twice daily, of celecoxib in approximately 4500 patients without initial ulceration. In 12-week endoscopic studies versus naproxen (1000 mg daily) and ibuprofen (2400 mg daily), celecoxib (100-800 mg daily) was associated with a significantly lower risk of peptic ulcers.
  • Data obtained in comparison with diclofenac (150 mg daily) were inconsistent. In two of the 12-week studies, the percentage of patients with endoscopically detected gastroduodenal ulcer was not significantly different on placebo, with celecoxib 200 mg twice daily and celecoxib 400 mg twice daily.
  • In a prospective long-term safety study (duration 6 to 15 months, CLASS study), 5800 osteoarthritis patients and 2200 patients with rheumatoid arthritis received celecoxib 400 mg twice daily (ie four times and two recommended dose for osteoarthritis and rheumatoid arthritis), ibuprofen 800 mg three times daily or diclofenac 75 mg twice daily (each at therapeutic doses). Twenty-two percent of patients included low doses of acetylsalicylic acid (≤ 325 mg daily), primarily for cardiovascular prevention. With respect to the primary endpoint identified as complicated ulcers (defined as haemorrhage, gastrointestinal perforation or occlusion), celecoxib was not significantly different from ibuprofen or diclofenac individually. There was also no statistically significant difference in the combined NSAID group for complicated ulcers (relative risk 0.77, 95% CI 0.41 – 1.46, lifetime values). of the study). In the mixed complication and symptomatic ulcer criteria, the incidence was significantly lower in the celecoxib group compared to the NSAID group (relative risk 0.66, 95% CI 0.45-0.97), but not between celecoxib and diclofenac. Patients taking concomitant celecoxib and low doses of acetylsalicylic acid showed 4-fold higher complicated ulcers compared to those under celecoxib alone. The incidence of clinically significant reductions in hemoglobin (> 2 g / dl), confirmed by repeated dosing, was significantly lower in patients receiving celecoxib compared to the NSAID group (relative risk 0.29, 95% CI 0.17 – 0.48). The significantly lower incidence of this event under celecoxib was maintained with or without taking acetylsalicylic acid.
  • 0001). Rates of gastrointestinal complications with clinical manifestations such as perforation, obstruction or hemorrhage were very low and not different between treatment groups (4-5 per group).
  • Cardiovascular Tolerance – Long-term studies in patients with sporadic adenomatous polyps.
  • Two studies evaluating celecoxib in subjects with sporadic adenomatous polyps were conducted: APC (Adenoma Prevention with Celecoxib) and PreSAP (Prevention of Spontaneous Adenomatous Polyps).
  • In the APC trial, a dose-dependent increase in the composite endpoint of cardiovascular death, myocardial infarction (MI), and cerebrovascular accident (CVA) was observed with celecoxib compared with placebo over 3 years of treatment. The PreSAP trial did not show a statistically significant increase in risk for the same composite endpoint.
  • Dans l’essai APC, le risque relatif regroupant décès d’origine cardiovasculaire, IDM et AVC (critère composite) était de 3,4 (IC à 95% 1,4-8,5) avec 400mg de célécoxib deux fois par jour et de 2,8 (IC à 95% 1,1-7,2) avec 200mg de célécoxib deux fois par jour, comparativement au placebo. Les valeurs cumulées pour ce critère composite sur une période de 3 ans étaient de 3,0 % (20/671 sujets) et 2,5% (17/685 sujets), respectivement comparé à 0,9% (6/679 sujets) pour le placebo. Les augmentations observées comparativement au placebo pour les deux groupes de dose célécoxib étaient principalement dues à une incidence accrue d’infarctus du myocarde.
  • In the PreSAP trial, the relative risk for this same composite endpoint was 1.2 (95% CI 0.6-2.4) with celecoxib 400mg twice daily compared to placebo. The cumulative values ​​for this composite criterion over a 3-year period were 2.3% (21/933 subjects) and 1.9% (12/628 subjects) respectively for celecoxib and placebo. The incidence of myocardial infarction was 1.0% (9/933 subjects) with daily administration of 400 mg celecoxib and 0.6% (4/628 subjects) with placebo.
  • Data from a third long-term ADAPT study did not show a significant increase in cardiovascular risk with celecoxib 200 mg twice daily compared to placebo. The relative risk for a similar composite endpoint (cardiovascular death, MI, stroke) was 1.14 (95% CI 0.61-2.12) with 200 mg celecoxib twice daily compared to placebo. The incidence of myocardial infarction was 1.1% (8/717 patients) with 200 mg celecoxib twice daily and 1.2% (13/1070 patients) with placebo.

what is celebrex side effects?

In addition to the desired effect, this can cause drug side effects.

The most common side effects are the following.

Sometimes (from 10 to 30 people in 100)

  • Increase in blood pressure . Do you have high blood pressure or do you use blood pressure reducers? Then this medication can increase blood pressure . Consult with your doctor. Perhaps the doctor can prescribe another anti-inflammatory analgesicsuch as diclofenac or ibuprofen. If you do need to use celecoxib your doctor will check your blood pressure extra.

Rarely (from 1 to 10 in 100 people)

  • Stomach complaints : stomach irritation, abdominal pain, nausea, vomiting, feeling full, lack of appetite, farmers and heartburn. You have less chance if you take this medicine with some food and a glass of water or milk. Do not use alcohol or other foods that irritate the stomach, such as sharp herbs. Do you suffer from esophageal inflammation due to rising stomach acid? The complaints can worsen. Contact your doctor if you notice. People over seventy years are more likely to experience side effects with this medication. Doctors therefore usually also prescribe a stomach protector . Even if you only use this medicine for a few days.
  • Intestinal complaints : diarrhea, constipation and flatulence.
  • stomach or intestinal ulcer or other severe damage to the stomach, intestines or esophagus. You notice that with nagging pain in the upper abdomen, severe stomach pain or pain behind the sternum. These damages can cause bleeding in the stomach and intestines. This can be seen in bloody diarrhea or black, tarry stools . Then discontinue use and contact a doctor. With a stomach haemorrhage it can happen that you vomit blood. Contact a doctor immediately. Have you ever had a stomach or intestinal ulcer?or have any other severe gastrointestinal disease, such as a stomach or intestinal bleed? You are more likely to have side effects on the stomach and intestines. Discuss with your doctor whether this medication is suitable for you. Your doctor may prescribe a stomach-protecting medication in addition to this medication. Even if you will only use this medicine for a few days.
  • Do you have an esophageal stenosis, a narrowing of the esophagus? You are more likely to have damage to the esophagus. Consult with your doctor about this. Maybe you can switch to a different medication.
  • Headache, dizziness and dizziness. This is usually about if you have become accustomed to this medication.
  • Skin rash with itching. This skin rash is very rarely caused by allergies . The rash can very rarely worsen or develop under the influence of strong sunlight or UV light from tanning beds. If you suffer from psoriasis : you may suffer more from this. Contact your doctor if your symptoms worsen.
  • Hypersensitivity to this medication. You will notice this by skin rash, hives and itching. Consult your doctor. Very rarely, a severe rash can develop with fever or blisters. Then contact a doctor immediately.
    Severe hypersensitivity can be seen from chest tightness or a swollen face. Then go immediately to a doctor. You may not use this medicine afterwards. Therefore, tell the pharmacist that you are hypersensitive to celecoxib. The pharmacy team can then ensure that you do not get this medicine or any other anti-inflammatory painkilleragain.
  • Thick ankles or wrists by retaining fluid in the arms and legs ( edema ).
  • Tightness due to fluid accumulation in the lungs . Especially people with heart failure can suffer from this. Talk to your doctor if your symptoms, such as tightnessand fluid retention, increase.

Very rare (affects less than 1 in 100 people)

  • Inflammation in the oral cavity and on the tongue.
  • Tinnitus or worse hearing. Contact your doctor for these symptoms.
  • Blurred vision or double vision. This is usually about if you have become accustomed to this medication.
  • Palpitations , chest pain and an accelerated heartbeat . Have you had angina (heart cramp), or have ever had a stroke or heart attack. Then you may only use this medication for a short time. Namely no longer than two weeks in a row. Consult with your doctor about this. Your doctor may be able to prescribe a different medication.
  • Hair loss .
  • Psychological complaints such as insomnia, fatigue, drowsiness, nightmares, anxiety, agitation, confusion, memory disorders, nervousness, anxiety, depression and hallucinations .
  • Impairment of the kidneys . You will notice this by swollen ankles and feet. Contact your doctor or pharmacist if this occurs.
  • Blood disorders, inflammation of the pancreas or liver inflammation . Consultyour doctor for one or more of the following symptoms: sudden severe upper abdominal pain, jaundice, unexplained bruising, extreme fatigue, sore throat with fever and blisters in the mouth. Talk to your doctor if you suffer from your pancreas. The complaints can worsen.

Very rare, when used for several weeks

  • Cardiovascular disease , such as more likely to have a heart attack or stroke . The risk of cardiovascular disease is greater in people who are more likely to have cardiovascular disease. People with high blood pressure , high cholesterol, diabetes, angina pectoris, window bones, narrowing or closing of the leg artery, people who smoke and people who have ever had a heart attack or thrombosis : consult your doctor before using this medicine . Your doctor may be able to prescribe another anti-inflammatory analgesic .

Consult your doctor if you suffer too much from one of the above mentioned side effects or if you experience other side effects that you are worried about.

Celebrex (Celecoxib) Capsule Side Effects
Celebrex (Celecoxib) Capsule Side Effects

Celebrex Capsule Interactions

celebrex capsule interactions with other drugs

Anti coagulants

  • Anti-coagulant activity should be monitored in patients taking warfarin or similar products, particularly in the first few days following initiation or change of celecoxib dosage as these patients have an increased risk of bleeding complications. For this reason, the use of oral anticoagulants should be accompanied by close monitoring of patients’ INR prothrombin levels, mainly in the first few days after initiation of celecoxib treatment or when the dosage of the drug is changed. celecoxib (see Warnings and Precautions section)).
  • Haemorrhage, including some fatal outcome, associated with prothrombin and INR prolongation have been observed in patients, particularly in elderly patients, concomitantly receiving celecoxib and warfarin.

Antihypertensive

  • NSAIDs can reduce the effects of antihypertensive drugs, including ACE inhibitors, angiotensin II receptor antagonists, diuretics and beta blockers. As with NSAIDs, the risk of acute renal failure, which is usually reversible, may be increased in some patients with impaired renal function (eg, dehydrated patients, patients taking diuretics or elderly patients) with the combination of ACE inhibitors, angiotensin II receptor antagonists, and / or diuretics with NSAIDs, including celecoxib (see Warnings and Precautions section).). Therefore, this combination should be administered with caution, especially in the elderly. Patients should be properly hydrated and renal function should be monitored after initiation of concomitant therapy and then periodically.
  • In a 28-day clinical trial in lisinopril-treated patients with stage I and II hypertension, 200 mg celecoxib twice daily did not result in a clinically increased significant mean systolic or diastolic blood pressure compared to placebo. The evaluation was performed by ambulatory monitoring of blood pressure for 24 hours. Of the patients treated with 200 mg celecoxib twice daily, 48% of them were considered non-responders to lisinopril at the final clinical visit versus 27% of placebo-treated patients (were defined as non-responders, subjects whose diastolic blood pressure measured with a blood pressure monitor> 90 mmHg or whose

Ciclosporin and tacrolimus

  • Joint administration of NSAIDs with ciclosporin or tacrolimus may increase the nephrotoxicity of ciclosporin or tacrolimus, respectively. Renal function should be monitored if celecoxib is combined with any of these drugs.

Acetylsalicylic acid

  • Celecoxib can be used in combination with a low dose of acetylsalicylic acid but can not be substituted for acetylsalicylic acid for cardiovascular prevention. In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications was found when concomitant administration of low doses of acetylsalicylic acid compared with use of celecoxib alone (see section 5.1 Pharmacodynamic properties ).

Pharmacokinetic interactions

Effects of celecoxib on other drugs

Inhibition of CYP2D6

  • Celecoxib is an inhibitor of cytochrome CYP2D6. Plasma drug concentrations substrates of this enzyme may be increased when combined with celecoxib. Drugs metabolized by CYP2D6 include, for example, antidepressants (tricyclics and selective serotonin reuptake inhibitors), neuroleptics, antiarrhythmics, etc. The dosage of the CYP2D6 substrates, the dose of which is adapted for each patient, may be reduced if necessary at the beginning of treatment with celecoxib or increased at the end of treatment with celecoxib.
  • Concomitant administration of 200 mg celecoxib twice daily resulted in 2.6 and 1.5 fold increase in plasma concentrations of dextromethorphan and metoprolol (CYP2D6 substrates), respectively. These increases are due to inhibition of metabolism of CYP2D6 substrates by celecoxib.

Inhibition of CYP2C19

  • In vitro studies have shown that celecoxib has the potential to inhibit cytochrome CYP2C19 catalyzed metabolism. The clinical significance of this in vitro observation is not known. Drugs metabolized by CYP2C19 are, for example, diazepam, citalopram and imipramine.

methotrexate

  • In patients with rheumatoid arthritis, celecoxib has no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (at doses used in rheumatology). However, adequate monitoring of the toxicity of methotrexate should be considered when combining these two drugs.

Lithium

  • In healthy subjects, concomitant administration of 200 mg, twice daily, of celecoxib and 450 mg, twice daily, of lithium resulted in an average increase of 16% in C max and 18% in AUC lithium. Therefore, patients treated with lithium should be closely monitored during the introduction or discontinuation of celecoxib.

Oral contraceptives

  • In an interaction study, celecoxib did not have clinically significant effects on the pharmacokinetic parameters of oral contraceptives (1 mg norethisterone / 35 μg ethinyl estradiol).

Glibenclamide / tolbutamide

  • Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate) or glibenclamide clinically significantly.

Effect of other drugs on celecoxib

CYP2C9 slow metabolizers

  • In CYP2C9 slow metabolizing subjects with increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors such as fluconazole may further increase celecoxib exposure. It is to avoid such associations in poor metabolisers known CYP2C9 (see Dosage and Administration and Pharmacokinetics )

Inhibitors and inducers of CYP2C9

  • Since celecoxib is primarily metabolized by cytochrome CYP2C9, it should be used at half the recommended dose in patients treated with fluconazole. Concomitant use of a single 200 mg dose of celecoxib with 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean C max increase of 60% and 130% of celecoxib. Concomitant use with CYP2C9 inducers such as rifampicin, carbamazepine, or barbiturates may result in reduced plasma concentrations of celecoxib.

Ketoconazole and antacids

  • There was no change in the pharmacokinetic parameters of celecoxib with ketoconazole or antacids.

Pediatric population

Interaction studies have only been performed in adults.

Celebrex (Celecoxib) Capsule Warnings and Precautions
Celebrex (Celecoxib) Capsule Warnings and Precautions

Warnings and Precautions

Gastrointestinal (GI) effects

Upper and lower gastrointestinal complications [perforations, ulcers or haemorrhages (PUH)], some of which were fatal, have been observed in celecoxib-treated patients.

Caution should be exercised in patients most at risk of developing a gastrointestinal complication with NSAIDs:

  • Elderly subjects,
  • Patients also treated with other NSAIDs,
  • Or with acetylsalicylic acid,
  •  With  glucocorticoids,
  • Patients who consume alcohol,
  • Or patients with a history of gastrointestinal illness such as ulcer and hemorrhage.

There is an increased risk of gastrointestinal side effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is used in combination with acetylsalicylic acid (even at low dosages).

A significant difference in gastrointestinal tolerance between the combination of selective COX-2 inhibitors and acetylsalicylic acid compared with NSAID and acetylsalicylic acid has not been demonstrated in long-term clinical trials (Pharmacodynamic properties ).

Concomitant use of NSAIDs

  • Concomitant use of celecoxib with NSAIDs other than aspirin should be avoided.

Cardiovascular effects

  • Compared to placebo, an increase in the number of serious cardiovascular (CV) events, mainly myocardial infarction (MI), was observed in a long-term study in patients with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg twice daily and 400 mg twice daily (see section 5.1 Pharmacodynamic properties ).
  • Due to the potential increase in cardiovascular risks of celecoxib depending on the dose and duration of treatment, this drug should be prescribed at the lowest effective daily dose for the shortest possible time.
  • The need for symptomatic treatment and its therapeutic efficacy for the patient should be re-evaluated periodically, particularly in patients with osteoarthritis (see sections Posology and method of administration , Contraindications , Adverse effects and Pharmacodynamic properties ).
  • Patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidemia, diabetes, smoking) should be treated with celecoxib only after a thorough evaluation (see section 5.1 ).
  • Because of their lack of antiplatelet effects, selective COX-2 inhibitors can not replace acetylsalicylic acid in the prevention of cardiovascular thromboembolic diseases. Therefore, antiplatelet therapy should not be discontinued.

Fluid retention and edema

  • As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in patients treated with celecoxib. Therefore, celecoxib should be administered with caution in patients with a history of heart failure, left ventricular dysfunction or arterial hypertension and in patients with pre-existing edema irrespective of the origin of the disorder.
  • Prostaglandin inhibition may result in deterioration of renal function and fluid retention. Precautions will also be necessary in patients treated with diuretics or at risk of hypovolemia.

Hypertension

  • Like all NSAIDs, celecoxib can cause hypertension or worsen pre-existing hypertension, increasing the incidence of cardiovascular events. Close monitoring of blood pressure at the start of treatment with celecoxib and during treatment should therefore be performed.

Renal and hepatic effects

  • The existence of impaired renal or hepatic function, particularly cardiac dysfunction, is more likely in the elderly. Therefore, appropriate medical supervision must be ensured.
  • NSAIDs, including celecoxib, may be responsible for renal toxicity. Clinical trials with celecoxib showed renal effects similar to those seen with comparator NSAIDs. The patients most at risk of developing renal toxicity are patients with renal insufficiency, heart failure, liver disorders, those taking diuretics, angiotensin-converting enzyme inhibitors, angiotensin II, as well as elderly patients (see section Interactions with other medicinal products and other forms of interaction ). These patients should be closely monitored during treatment with celecoxib.
  • Some cases of severe liver reactions have been reported with celecoxib, including fulminant hepatitis (some with fatal outcome), liver necrosis, and liver failure (some with fatal outcome or requiring liver transplantation). In cases where time to onset was reported, most severe hepatic reactions occurred within one month of starting treatment.
  • During treatment, appropriate measures will be taken and discontinuation of celecoxib therapy should be considered if there is any functional impairment of the above mentioned organs.

Inhibition of CYP2D6

  • Celecoxib inhibits CYP2D6. Although it is not a potent inhibitor of this enzyme, a dose reduction may be necessary for drugs that are dose-adjusted for each patient and are metabolized by CYP2D6 ( and other forms of interaction ).

CYP2C9 slow metabolizers

  • Patients known to be poor metabolisers of CYP2C9 should be treated with caution.

Skin reactions and systemic hypersensitivity reactions

  • Serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell’s syndrome), have been very rarely reported in association with the use of celecoxib (Side effects ).
  • The risk of these effects appears to be highest at the beginning of treatment, the appearance of these effects being in the majority of cases during the first month of treatment. Severe hypersensitivity reactions (including anaphylaxis, angioedema, and drug-induced rash with eosinophilia and systemic symptoms (DRESS))).
  • Patients with a history of allergy to sulfonamides or any other drug may have an increased risk of serious skin reactions or hypersensitivity.
  • Celecoxib should be stopped at the first signs of skin rash, mucosal lesions or any other sign of hypersensitivity.

General effects

  • Celecoxib may mask fever and other signs of inflammation.

Use with oral anticoagulants

  • In patients treated concurrently with warfarin, serious bleeding, including some fatal outcome, have been reported.
  • Increased prothrombin time (INR) has been reported with concomitant treatments. It should therefore be closely monitored in patients receiving warfarin / coumarin-type oral anticoagulants, particularly when initiating celecoxib therapy or when changing the dosage of celecoxib. and other forms of interaction).
  • Concomitant use of anticoagulants and NSAIDs may increase the risk of bleeding. Caution should be exercised when co-administering celecoxib with warfarin or other oral anticoagulants, including new anticoagulants (eg, apixaban, dabigatran and rivaroxaban).

excipients

  • Celebrex (Celecoxib) Capsule 100 mg capsules contain lactose (149.7 mg). Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

Drive and use machines

Patients who experience dizziness, lightheadedness or drowsiness while taking Celebrex (Celecoxib) Capsule should refrain from driving or operating machinery.

Pregnancy / Breastfeeding / Fertility

celebrex and pregnancy side effects

  • Studies in animals (rats and rabbits) have shown reproductive toxicity including malformations (see sections Contraindications and Preclinical Safety Data ). Inhibition of prostaglandin synthesis may have a deleterious effect on pregnancy. Data from epidemiological studies point to an increased risk of spontaneous miscarriage after the use of prostaglandin synthesis inhibitors in early pregnancy.
  • In humans, the risk during pregnancy is unknown but can not be ruled out. Like other drugs that inhibit prostaglandin synthesis, celecoxib can cause uterine inertia and premature closure of the ductus arteriosus in the last trimester of pregnancy. Celecoxib is contraindicated in pregnancy and in women who may become pregnant (see sections Contraindications and Warnings and Precautions for Use ). If pregnancy is discovered during treatment, celecoxib should be discontinued.

Breastfeeding

  • Celecoxib is excreted in female milk at concentrations similar to those found in plasma.
  • The administration of celecoxib to a small number of breastfeeding women has shown a very small passage of celecoxib in breast milk. Patients treated with celecoxib should not breastfeed.

Fertility

  • Because of their mechanism of action, the use of NSAIDs, including celecoxib, can delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women.

What should I do if I miss a dose?

With chronic pain it is important to consistently take this medication. If you have forgotten a dose :

If you take this medicine once a day :

does it take more than 8 hours before you take the next dose normally?

  • Take the forgotten dose as yet. Does it take less than 8 hours? Skip the forgotten dose .

If you take this medicine twice a day :

does it take more than 4 hours before you take the next dose normally? 

  • Take the forgotten dose as yet.

Does it take less than 4 hours? 

  • Skip the forgotten dose .

What happens if I overdose from Celebrex ?

  • There is no clinical experience of overdose.
  • Single doses up to 1200 mg and repeated doses up to 1200 mg twice daily have been administered for 9 days to healthy subjects without causing clinically significant adverse effects.
  • In case of possible overdose, appropriate medical management is necessary, eg evacuation of gastric contents, clinical monitoring and, if necessary, symptomatic treatment.
  • Dialysis is unlikely to be an effective means of eliminating the drug because of its strong protein binding.

What is  Forms and Composition?

  • Capsule 100 mg (with two blue bands indicating respectively 7767 and 100, white and opaque):   Box of 30, under platelets.
  • Hospital model: Box of 100, under pads. 200 mg capsule (with two gold bands indicating 7767 and 200 respectively, white and opaque):   Box of 30, under platelets. Hospital model: Box of 100, under pads.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
]]>
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celestene 2 mg medicine Uses, Dosage, Side Effects &Warnings https://edrug-online.com/294/celestene-medicine.html https://edrug-online.com/294/celestene-medicine.html#respond Thu, 20 Aug 2020 11:57:23 +0000 https://www.edrug-online.com/?p=294 celestene 2 mg medicine Uses, Dosage, Side Effects &WarningsCelestene 2 mg Generic medicine of the therapeutic class: Anti-inflammatory active ingredients: Betamethasone Important to know about Celestene ? This medication is a corticosteroid. It is indicated in certain diseases, where it is used for its anti-inflammatory effect. celestene 2mg what is it used for and indication ? Conditions or diseases: Collagenosis and connectivitis: Evolutionary thrusts of […]]]> celestene 2 mg medicine Uses, Dosage, Side Effects &Warnings

Celestene 2 mg Generic medicine of the therapeutic class: Anti-inflammatory
active ingredients: Betamethasone

Important to know about Celestene ?

  • This medication is a corticosteroid.
  • It is indicated in certain diseases, where it is used for its anti-inflammatory effect.

celestene 2mg what is it used for and indication ?

Conditions or diseases:
Collagenosis and connectivitis:
  • Evolutionary thrusts of systemic diseases, including: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.
Dermatological:
  • Severe autoimmune bullous dermatoses, especially pemphigus and bullous pemphigoid.
  • Serious forms of angiomas of the infant.
  • Some forms of lichen plan.
  • Some acute urticaria.
  • Severe forms of neutrophilic dermatoses.
Digestives:
  • Evolutionary thrusts of ulcerative colitis and Crohn’s disease.
  • Chronic active autoimmune hepatitis (with or without cirrhosis).
  • Severe acute alcoholic hepatitis, histologically proven.
Endocrine:
  • Subacute Thyroiditis of severe De Quervain.
  • Some hypercalcemia.
Hematologic:
  • Severe immunological thrombocytopenic purpura.
  • Autoimmune haemolytic anemias.
  • In combination with various chemotherapies in the treatment of lymphoid malignant hemopathies.
  • Chronic erythroblastopenia, acquired or congenital.
Infectious:
  • Tuberculous pericarditis and severe forms of life-threatening tuberculosis.
  • Pneumocystis carinii pneumonia with severe hypoxia.
Neoplasms:
  • Antiemetic treatment during antineoplastic chemotherapy.
  • Oedematous and inflammatory thrust associated with antineoplastic treatments (radio and chemotherapy).
Nephrological:
  • Nephrotic syndrome with minimal glomerular lesions.
  • Nephrotic syndrome of primitive segmental and focal hyalinoses.
  • Stages III and IV of lupus nephropathy.
  • Intrarenal granulomatous sarcoidosis.
  • Vasculitis with renal involvement.
  • Primitive extracapillary glomerulonephritis
Neurological:
  • Gravis.
  • Cerebral edema of tumoral cause.
  • Chronic polyradiculoneuropathy, idiopathic, inflammatory.
  • Infant spasm (West syndrome), Lennox-Gastaut syndrome.
  • Multiple sclerosis in relapse, in relays of an intravenous corticotherapy.
Ophthalmological:
  • Uveitis anterior and posterior severe.
  • Exophthalmos oedematous.
  • Some optic neuropathies, in reliance on intravenous corticosteroids (in this indication, oral first-line is not recommended).
ENT:
  • Some serous otitis.
  • Nasosinus polypsis.
  • Some acute or chronic sinusitis.
  • Seasonal allergic rhinitis in short cure.
  • Stridulous acute laryngitis (subglottic laryngitis) in children.
Respiratory:
  • Persistent asthma, preferably in short course, in case of failure of inhaled treatment at high doses.
  • Exacerbations of asthma, especially severe acute asthma.
  • Chronic obstructive pulmonary disease in assessing the reversibility of obstructive syndrome.
  • Sarcoidosis progressive.
  • Diffuse interstitial pulmonary fibrosis.
Rheumatologic:
  • Rheumatoid arthritis and some polyarthritis.
  • Rhizomelic pseudopolyarthritis and Horton’s disease.
  • Acute articular rhumatism.
  • Severe and rebellious cervicobrachial neuralgia.
Organ Transplantation and Hematopoietic Allogeneic Stem Cells:
  • Prophylaxis or treatment of transplant rejection.
  • Prophylaxis or treatment of graft-versus-host disease.

Celestene Dosage

Oral way.

  • · Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg betamethasone.
  • The tablets can be swallowed as is with a little water or dissolved in a little water, preferably during meals.

RESERVED FOR ADULTS

  • Celestene 2 mg is particularly suitable for the treatment of attack or short-term treatments requiring medium or high doses in adults.
  • In maintenance treatment, there are more appropriate dosages.
  • In children, there are more appropriate dosages and pharmaceutical forms.
  • · The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient’s response and the tolerance to the treatment.
  • Attack treatment : 0.05 mg to 0.2 mg / kg / day (0.35 mg to 1.2 mg / kg / day prednisone equivalent). As an indication : 1.5 to 6 tablets in an adult of 60 kg.
  • In severe inflammatory diseases , the dosage varies from 0.1 to 0.2 mg / kg / day of betamethasone (0.75 mg / kg / day to 1.2 mg / kg / day equivalent prednisone). As an indication : 3 to 6 tablets per day for an adult of 60 kg.
  • The very exceptional situations may require higher doses.

IN GENERAL

  • Treatment at the “attack dose” should be continued until the disease is well controlled. Decay must be slow. Obtaining a weaning is the goal. Maintaining a maintenance dose (minimum effective dose) is a compromise that is sometimes necessary.
  • For prolonged treatment at high doses, the first doses can be divided into two daily doses. Thereafter, the daily dose may be administered as a single dose preferably in the morning during the meal.

· Discontinuation of treatment

  • The rate of withdrawal depends mainly on the duration of treatment, the starting dose and the disease.
  • The treatment causes resting secretions of ACTH and cortisol with sometimes lasting adrenal insufficiency. When weaning, stopping should be done gradually, in stages because of the risk of relapse: reduction of 10% every 8 to 15 days on average.
  • For short courses of less than 10 days, stopping treatment does not require decay.

When decreasing doses from celestene (prolonged cure):

at the dosage of 5 to 7 mg of prednisone equivalent, when the causal disease no longer requires corticosteroid treatment, it is desirable to replace the synthetic corticoid with 20 mg / day of hydrocortisone until recovery of corticotropic function. If corticosteroid therapy is to be maintained at less than 5 mg prednisone equivalent per day, a small dose of hydrocortisone can be added to achieve a hydrocortisone equivalent of 20 to 30 mg per day. When the patient is only under hydrocortisone, it is possible to test the corticotropic axis by endocrine tests. These tests do not eliminate the possibility of adrenal insufficiency during a stress.

Under hydrocortisone or even at a distance from arrest, the patient should be advised of the need to increase the usual dosage or to resume replacement therapy (eg 100 mg hydrocortisone intramuscularly every 6 to 8 hours) in case stress: surgery, trauma, infection.

Contraindications

This medication is generally contraindicated in the following situations (there is, however, no absolute contraindication for a life-saving corticosteroid therapy):

  • Any infectious condition other than the specified indications ( see section Therapeutic indications ),
  • Certain evolving viroses (in particular hepatitis, herpes, chickenpox, shingles),
  • Psychotic states not yet controlled by treatment,

Live vaccines

  • · Hyper-sensitivity to one of the compounds,
  • Phenylketonuria (linked to the presence of aspartame).
  • This drug is generally not recommended in combination with non-antiarrhythmic drugs, giving torsades de pointes ( see section Interactions with other drugs and other forms of interactions ).

How it works Celestene

Pharmacotherapeutic group: GLUCOCORTICOID – SYSTEMIC USE

( H. Non-sexual hormones )

  • Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones. Synthetic corticosteroids, including this specialty, are used primarily for their anti-inflammatory effect. In high doses, they reduce the immune response.
  • Their metabolic and sodium retention effect is less than that of hydrocortisone.

Celestene 2 mg Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This drug, essential, is most often well tolerated when one follows the recommendations and especially the diet (see Warnings and precautions). It may nevertheless result, according to the dose and the duration of the treatment, more or less troublesome effects.

The most frequently encountered are:

  1. · Swelling and redness of the face, weight gain
  2. · Appearance of blue
  3. · Elevation of blood pressure
  4. · Excitement and sleep disorders
  5. · Bone fragility
  6. · Modification of certain biological parameters (salt, sugar, potassium), which may require a diet or additional treatment.

Other, much rarer effects have been observed:

  1. · Risk of insufficiency of secretion of the adrenal gland
  2. · Growth disorder in children
  3. · Rule disorders
  4. · Muscle weakness
  5. · Hiccups, ulcers and other digestive disorders
  6. · Skin disorders
  7. · Some forms of glaucoma (increased pressure inside the eye) and cataracts (opacification of the lens).

Celestene Interactions

Associations advised against

Drugs giving torsades de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)

Use substances that do not have the disadvantage of causing torsades de pointes in case of hypokalemia.

Associations subject to precautions for use

Acetylsalicylic acid by general route and by extrapolation other salicylates

Decrease of salicylemia during corticosteroid treatment and risk of salicylate overdose after discontinuation, by increased elimination of salicylates by corticosteroids.

Adjust salicylate doses during combination and after discontinuation of corticosteroid treatment.

Antiarrhythmics giving torsades de pointes (amiodarone, bretylium, disopyramide, quinidine, sotalol).

Hypokalemia is a contributing factor as well as bradycardia and a preexisting long QT space.

Prevent hypokalemia, correct it if necessary; monitor the QT space. In case of torsade, do not administer antiarrhythmic (electrosystolic drive).

 Oral anticoagulants

  • Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and that of the coagulation factors.
  • Haemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) at high doses or prolonged treatment for more than 10 days.
  • When the association is justified, strengthen supervision: biological control 8 th day and every 15 days during and after corticosteroid discontinuation.
  • Other hypokalaemic agents (alone or associated hypokalaemic diuretics, stimulant laxatives, amphotericin B (IV route)).
  • Increased risk of hypokalemia by additive effect.
  • Monitor the serum potassium, correct if necessary especially in case of digitalis therapy.

Digitalis

  • Hypokalemia favoring the toxic effects of digitalis.
  • Monitor the serum potassium, correct if necessary and possibly ECG.

Parenteral heparins

  • Aggravation by heparin of the hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or prolonged treatment longer than 10 days.
  • The association must be justified, strengthen surveillance.
  • Enzyme inducers: carbamazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin.
  • Decreased plasma levels and efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important for addisonians and transplant patients.
  • Clinical and biological surveillance, adjustment of the dosage of corticosteroids during the association and after discontinuation of the enzyme inducer.

 Insulin, metformin, sulphonylureas

  • Elevation of blood glucose with sometimes ketosis (decreased tolerance to carbohydrates by corticosteroids).
  • Prevent the patient and strengthen blood and urinary self-monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of the antidiabetic during treatment with corticosteroids and after discontinuation.

Isoniazid (described for prednisolone)

  • Decreased plasma levels of isoniazid. Invoked mechanism: increased hepatic metabolism of isoniazid and decreased glucocorticoid.
  • Clinical and biological surveillance.
  • Gastrointestinal topical: salts, oxides and hydroxides of magnesium, aluminum and calcium (described for prednisolone, dexamethasone).
  • Decreased digestive absorption of glucocorticoids.
  • Take the gastrointestinal topical glucocorticoid away (more than 2 hours if possible).

Associations to consider

Antihypertensive

  • Decreased antihypertensive effect (water-soluble retention of corticosteroids).

 Alpha interferon

  • Risk of inhibition of the action of interferon.

 Attenuated live vaccines

  • Risk of generalized illness, possibly fatal. This risk is increased in subjects already immunocompromised by the underlying disease.
  • Use inactivated vaccine when present (poliomyelitis).

Warnings and Precautions

Special warnings:

  1. · In cases of peptic ulcer disease, corticosteroids are not contraindicated if anti-ulcer therapy is combined.
  2. In case of ulcerative history, corticosteroid therapy may be prescribed, with clinical monitoring and if necessary after fibroscopy.
  3. · Corticosteroid therapy can promote the occurrence of various infectious complications due to bacteria, yeasts and parasites. The occurrence of malignant yellows is a significant risk.
  4. All subjects from an endemic area (tropical, subtropical, southern Europe) should have parasitological examination of stool and systematic eradication before corticosteroid therapy.
  5. Evidence of an infection may be masked by corticosteroid therapy.
  6. It is important, before the start of treatment, to remove any possibility of visceral foci, particularly tuberculosis, and to monitor, during treatment, the appearance of infectious pathologies.
  7. In case of old tuberculosis, prophylactic anti-tuberculosis treatment is necessary, if there are important radiological sequelae and if it can not be ensured that a well-conducted treatment of 6 months with rifampicin has been given.
  8. · The use of corticosteroids requires particularly appropriate monitoring, especially in elderly patients and in cases of ulcerative colitis (risk of perforation), recent intestinal anastomoses, renal failure, hepatic insufficiency, osteoporosis, myasthenia gravis.
  9. · This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use

· In case of long-term corticosteroid treatment :

  1. o A diet low in fast and hyperprotid absorption sugars must be associated, because of the hyperglycemic effect and the protein catabolism with negativization of the nitrogen balance.
  2. o Hydrosoduced retention is usual, partly responsible for a possible rise in blood pressure. Sodium lapport will be reduced for daily dosages greater than 15 or 20 mg prednisone equivalent and moderate in long-term low dose treatments.
  3. o Potassium supplementation is justified only for high-dose treatments, prescribed for a long time or in case of risk of rhythm disorders or association with hypokalaemic treatment.
  4. o The patient must always have a calcium and vitamin D intake.
  5. o When corticosteroid therapy is essential, diabetes and high blood pressure are not contraindications, but treatment can lead to imbalance. Their management should be re-evaluated.
  6. o Patients should avoid contact with individuals with chickenpox or measles.

· Attention is drawn to athletes , this specialty containing an active ingredient that can induce a positive reaction of the tests performed during anti-doping controls.

Associations advised against

Drugs giving torsades de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)

  • Use substances which do not have the disadvantage of causing torsades de pointes in case of hypokalemia.

Associations subject to precautions of use

Acetylsalicylic acid by general route and by extrapolation other salicylates

  • Decrease of salicylemia during corticosteroid treatment and risk of salicylate overdose after discontinuation, by increased salicylate elimination by corticosteroids.
  • Adjust salicylate doses during combination and after stopping corticosteroid treatment.

Antiarrhythmics giving torsades de pointes (amiodarone, bretylium, disopyramide, quinidine, sotalol).

  • Hypokalemia is a contributing factor as well as bradycardia and a preexisting long QT space.
  • Prevent hypokalemia, correct if necessary; monitor the QT space. In case of torsade, do not administer anantiarrhythmic (electrosystolic drive).

Oral anticoagulants

  • Possible impact of corticosteroid therapy on the metabolism of oral lanticoagulant and coagulation factors.
  • Haemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) at high doses or prolonged treatment for more than 10 days.
  • When the association is justified, reinforce the monitoring: biological control on the 8th day, then every 15 days during the corticotherapy and after its stop.

Other hypokalaemic agents (alone or associated hypokalaemic diuretics, stimulant laxatives, amphotericin B (IV route)).

  • Hypokalemia favoring the toxic effects of digitalis.
  • Monitor the serum potassium, correct if necessary and possibly ECG.

Parenteral heparins

  • Heparin aggravation of hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or prolonged treatment greater than 10 days.
  • Association must be justified, strengthen monitoring.

Enzyme inducers: carbamazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin.

  • Decreased plasma levels and the efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important for addisonians and transplant patients.
  • Clinical and biological surveillance, adaptation of the dosage of corticosteroids during the association and after the end of the enzymatic inducer.

 Insulin, metformin, sulphonylureas

  • Elevation of blood glucose with sometimes ketosis (decreased tolerance to carbohydrates by corticosteroids).
  • Prevent the patient and strengthen blood and urinary monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of antidiabetic during treatment with corticosteroids and after stopping.

 Isoniazid (described for prednisolone)

  • Decreased plasma levels of lisoniazide. Invoked mechanism: increased lisoniazide hepatic metabolism and decreased glucocorticoid metabolism.
  • Clinical and biological surveillance.

Gastrointestinal topical: salts, oxides and hydroxides of magnesium, aluminum and calcium (described for prednisolone, dexamethasone).

  • Decreased digestive absorption of glucocorticoids.
  • Take the gastrointestinal topical glucocorticoid away (more than 2 hours if possible).

Associations to consider

Antihypertensives

  • Decreased antihypertensive effect (water-soluble retention of corticosteroids).

Alpha interferon

  • Risk of inhibition of the action of interferon.

 Attenuated live vaccines

  • Risk of generalized illness, possibly fatal. This risk is increased in subjects already immunocompromised by the underlying disease.
  • Use inactivated vaccine when present (poliomyelitis).

Drive and use machines:

Not applicable.

PREGNANCY / BREAST FEEDING / FERTILITY

celestone during pregnancy

  • In animals, the experiment shows a teratogenic effect that varies according to the species.In humans, there is a placental transfer. However, epidemiological studies have not detected any risk of malformation related to taking corticosteroids during
  • st  quarter. In chronic diseases, requiring treatment throughout pregnancy, a slight intrauterine growth retardation is possible. Neonatal adrenal insufficiency has been observed exceptionally after high dose corticosteroid therapy. It is justified to observe a period of clinical surveillance (weight, diuresis) and biological monitoring of the newborn.
  • As a result, corticosteroids may be prescribed during pregnancy, if needed.

Breastfeeding

In case of treatment at large doses and chronically, breastfeeding is not recommended.

What happens if I overdose from Celestene ?

Call your doctor or pharmacist if you have used CELESTENE 2 mg dispersible tablet breakable in greater or greater amounts than prescribed

What is  Forms and Composition?

FORMS and PRESENTATIONS
  • Dispersible 2 mg tablet (white):   Bottle of 20.
COMPOSITION
  p cp
betamethasone 2 mg
  • Excipients: granulated lactose monohydrate and cellulose powder 75/25 (Cellactose), crospovidone (Polyplasdone XL 10), aspartame, magnesium stearate.
  • Excipients with known effect: aspartame (E951), lactose.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
]]>
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Solupred Uses, Dosage, Side Effects, Precautions & Warnings https://edrug-online.com/244/solupred.html https://edrug-online.com/244/solupred.html#respond Wed, 19 Aug 2020 13:20:52 +0000 http://www.edrug-online.com/?p=244 What is Solupred?solupred medicine Generic drug of the therapeutic class: Anti-inflammatory active ingredients: Prednisolone What is Solupred? This medication is a corticosteroid. It is indicated in certain diseases, where it is used for its anti-inflammatory effect. what is solupred used for and indication ? Conditions or diseases: Collagenosis, connectivites: Evolutionary thrusts of systemic diseases, including: systemic lupus erythematosus, […]]]> What is Solupred?

solupred medicine Generic drug of the therapeutic class: Anti-inflammatory
active ingredients: Prednisolone

What is Solupred?

  • This medication is a corticosteroid.
  • It is indicated in certain diseases, where it is used for its anti-inflammatory effect.

what is solupred used for and indication ?

Conditions or diseases:
Collagenosis, connectivites:
  • Evolutionary thrusts of systemic diseases, including: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.
Dermatological:
  • Severe autoimmune bullous dermatoses, especially pemphigus and bullous pemphigoid.
  • Serious forms of angiomas of the infant.
  • Some forms of lichen plan.
  • Some acute urticaria.
  • Severe forms of neutrophilic dermatoses.
Digestives:
  • Evolutionary thrusts of ulcerative colitis and Crohn’s disease.
  • Chronic active autoimmune hepatitis (with or without cirrhosis).
  • Severe acute alcoholic hepatitis, histologically proven.
Endocrine:
  • Subacute thyroiditis of severe Quervain.
  • Some hypercalcemia.
Hematologic:
  • Severe immunological thrombocytopenic purpura.
  • Autoimmune haemolytic anemias.
  • In combination with various chemotherapies in the treatment of lymphoid malignant hemopathies.
  • Chronic erythroblastopenia, acquired or congenital.
Infectious:
  • Tuberculous pericarditis and severe forms of life-threatening tuberculosis.
  • Pneumocystis carinii pneumonia with severe hypoxia.
Neoplasms:
  • Antiemetic treatment during antineoplastic chemotherapy.
  • Oedematous and inflammatory thrust associated with antineoplastic treatments (radio and chemotherapy).
Nephrological:
  • Nephrotic syndrome with minimal glomerular lesions.
  • Nephrotic syndrome of primitive segmental and focal hyalinoses.
  • Stages III and IV of lupus nephropathy.
  • Intrarenal granulomatous sarcoidosis.
  • Vasculitis with renal involvement.
  • Primitive extracapillary glomerulonephritis
Neurological:
  • Gravis.
  • Cerebral edema of tumoral cause.
  • Chronic polyradiculoneuropathy, idiopathic, inflammatory.
  • Infant spasm (West syndrome), Lennox-Gastaut syndrome.
  • Multiple sclerosis in relapse, in relays of an intravenous corticotherapy.
Ophthalmological:
  • Uveitis anterior and posterior severe.
  • Exophthalmos oedematous.
  • Some optic neuropathies, in reliance on intravenous corticosteroids (in this indication, oral first-line is not recommended).
ENT:
  • Some serous otitis.
  • Nasosinus polypsis.
  • Some acute or chronic sinusitis.
  • Seasonal allergic rhinitis in short cure.
  • Stridulous acute laryngitis (subglottic laryngitis) in children.
Respiratory:
  • Persistent asthma, preferably short-course in case of failure of inhaled treatment in high doses.
  • Exacerbations of asthma, especially severe acute asthma.
  • Chronic obstructive pulmonary disease in assessing the reversibility of obstructive syndrome.
  • Sarcoidosis progressive.
  • Diffuse interstitial pulmonary fibrosis.
Rheumatologic:
  • Rheumatoid arthritis and some polyarthritis.
  • Rhizomelic pseudopolyarthritis and Horton’s disease.
  • Acute articular rhumatism.
  • Severe and rebellious cervicobrachial neuralgia.
Organ Transplantation and Hematopoietic Allogeneic Stem Cells:
  • Prophylaxis or treatment of transplant rejection.
  • Prophylaxis or treatment of graft-versus-host disease.

Solupred Dosage

Oral way.

  1. Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 5 mg prednisolone.
  2. The tablets will be dissolved in a glass of water during the meal.
  3. If the calculated weight dose is less than 5 mg per day, a more appropriate dosage is available.

solupred dosage adulte

  1. The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient’s response and the tolerance to the treatment.
  2. Attack treatment : 0.35 to 1.2 mg / kg / day. As an indication : 4 to 14 tablets in an adult of 60 kg.
  3. In severe inflammatory diseases , the dosage ranges from 0.75 to 1.2 mg / kg / day. As an indication: 9 to 14 tablets per day for an adult of 60 kg.
  4. The very exceptional situations may require higher doses.
  5. Maintenance treatment: 5 to 15 mg / day, or 1 to 3 tablets a day.

solupred dosage child

  1. The dosage should be appropriate to the condition and weight of the child.
  2. Attack treatment : 0.5 to 2 mg / kg / day. As an indication : 2 to 10 tablets for a child of 25 kg.
  3. Maintenance treatment : 0.25 to 0.5 mg / day. As an indication : 1 to 2 tablets for a child of 25 kg.
  4. The prescription of alternating day corticosteroid therapy (one day without corticosteroid and the second day with a double dosage of the daily dosage that would have been required) is used in children to try to limit stunting.
  5. This alternate day schedule can be considered only after control of inflammatory disease by high doses of corticosteroids, and when during decay no rebound is observed.

IN GENERAL

  1. Treatment at the “attack dose” should be continued until the disease is well controlled. In the case of long-term treatment, the decrease must be slow. Obtaining a weaning is the goal. Maintaining a maintenance dose (minimum effective dose) is a compromise that is sometimes necessary.
  2. For prolonged treatment at high doses, the first doses can be divided into two daily doses. Thereafter, the daily dose may be administered as a single dose preferably in the morning during the meal.

Stop treatment

  1. The rate of withdrawal depends mainly on the duration of treatment, the starting dose and the disease.
  2. The treatment causes resting secretions of ACTH and cortisol with sometimes lasting adrenal insufficiency. When weaning, the stop must be done gradually, in stages, because of the risk of relapse: reduction of 10% every 8 to 15 days on average.
  3. For short courses of less than 10 days, stopping treatment does not require decay.
  4. When decreasing doses (prolonged cure): at the dosage of 5 to 7 mg of prednisone equivalent, when the causal disease no longer requires corticosteroid treatment, it is desirable to replace the synthetic corticoid with 20 mg / day of hydrocortisone until recovery of corticotropic function. If corticosteroid therapy is to be maintained at less than 5 mg prednisone equivalent per day, a small dose of hydrocortisone can be added to achieve a hydrocortisone equivalent of 20 to 30 mg per day. When the patient is only under hydrocortisone, it is possible to test the corticotropic axis by endocrine tests. These tests do not eliminate, alone, the possibility of occurrence of adrenal insufficiency during a stress.
  5. Under hydrocortisone or even at a distance from arrest, the patient should be advised of the need to increase the usual dosage or to resume replacement therapy (eg 100 mg hydrocortisone intramuscularly every 6 to 8 hours) in case stress: surgery, trauma, infection.

Contraindications

  • This medication is generally contraindicated in the following situations (there is, however, no absolute contraindication for a life-saving corticosteroid therapy):
    • Any infectious condition, excluding the specified indications (see section Therapeutic indications ),
    • Certain evolving viroses (in particular hepatitis, herpes, chickenpox, shingles),
    • Psychotic states not yet controlled by treatment,
  • Live vaccines
  • Hypersensitivity to prednisolone or to any of the excipients
  • Phenylketonuria (due to the presence of aspartame).

How it works Solupred

Pharmacotherapeutic group: GLUCOCORTICOIDES, ATC code: H02AB06.

H: Non-sexual systemic hormones ).

  • Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones. Synthetic corticosteroids, including this specialty, are used primarily for their anti-inflammatory effect.
  • In high doses, they reduce the immune response. Their metabolic and sodium retention effect is less than that of hydrocortisone.

Solupred Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine, essential for your health, is most often well tolerated when you follow the recommendations and especially the diet low in salt, sugar and high protein (see also the paragraph “Warnings and precautions”).

It may nevertheless result, depending on the dose and the duration of the treatment, more or less troublesome effects.

The most common side effects are:

  1. · A modification of some results of your analyzes (salt, sugar, potassium) that may require a diet or a complementary treatment.
  2. · An appearance of bruises.
  3. · Elevated blood pressure, water retention and salt may lead to heart failure.
  4. · Mood disorders (excitement, euphoria), sleep disorders (insomnia).
  5. · A set of disorders called Cushing’s syndrome recognizable by weight gain, swelling and redness of the face, excessive growth of hair.
  6. · Bone fragility (osteoporosis, fractures, vertebral compression in particular).
  7. · Painful disorders of bone at the hip larticulation (osteonecrosis).

Other, much rarer effects have been observed:

  1. · Insufficient production of hormones by the gland located above the kidneys (adrenal gland).
  2. · Stunting in children
  3. · Rule disorders.
  4. · Muscle weakness, tendon rupture especially if SOLUPRED 5 mg, effervescent tablet is associated with certain antibiotics (fluoroquinolones).
  5. · Digestive disorders: digestive ulcer, bleeding and digestive perforations,
  6. · Inflammation of the pancreas especially among child.
  7. · A weakening of the skin, a delay of cicatrization, of lacné.
  8. · Disorientation in time and space (confusion), convulsion, depressive state at the end of treatment.
  9. · Vision problems that may lead to loss of vision: blurred vision, some forms of glaucoma (increased fluid pressure) and cataracts (opacification of the lens), chorioretinopathies (retinal disease).
  10. · Endocrine disorders (hormonal disorders): occurrence of seizures related to the presence of pheochromocytoma (tumor of the adrenal glands) and can put your life in danger.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information on the safety of the medicine.

Solupred Interactions

Hypokalaemic drugs

  • Hypokalemia is a factor favoring the development of cardiac arrhythmias (torsades de pointes, in particular) and increasing the toxicity of certain drugs, for example digoxin. As a result, medications that can lead to hypokalemia are involved in a large number of interactions.
  • These are hypokalaemic diuretics, alone or in combination, stimulant laxatives, glucocorticoids, tetracosactide and amphotericin B (route IV).

Associations advised against

(See section Warnings and precautions for use )

Attenuated live vaccines

  • Risk of widespread, life-threatening vaccine disease.

Acetylsalicylic acid

  • Increased hemorrhagic risk.
  • Combination not recommended with anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose and / or ≥ 3 g daily).

Associations subject to precautions for use

Oral anticoagulants

  • Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and that of the coagulation factors. Hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or in prolonged treatment greater than 10 days. When the association is justified, reinforce the monitoring: biological control on the 8th day, then every 15 days during the corticotherapy and after its stop.

Other hypokalaemic drugs (diuretics with or without hypokalemia, stimulant laxatives, IV amphotericin B, tetracosactide)

  • Increased risk of hypokalemia. Monitoring of serum potassium with, if necessary, correction.

Enzymatic inducing anticonvulsants: carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone

  • Decreased plasma concentrations and corticosteroid efficacy by increased hepatic metabolism by the inducer; the consequences are particularly important for addisoners treated with hydrocortisone and for transplantation. Clinical and biological surveillance; adjustment of corticosteroid dosage during treatment with the inducer and after discontinuation.

Digital

  • Hypokalemia favoring the toxic effects of digitalis. Correct any hypokalemia beforehand and perform clinical, electrolytic and electrocardiographic monitoring.

Insulin, metformin, sulphonylureas

  • Increased blood glucose with sometimes ketoacidosis by decreasing glucocorticoid tolerance due to corticosteroids. Prevent the patient and strengthen the self-monitoring glycemic and urinary, especially at the beginning of treatment. If necessary, adjust the dosage of the antidiabetic during treatment with corticosteroids and after discontinuation.

Isoniazid

  • Described for prednisolone: ​​decreased plasma concentrations of isoniazid. Invoked mechanism: increased hepatic metabolism of isoniazid and decreased glucocorticoid. Clinical and biological surveillance.

Drugs that may give torsades de pointes: class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide), certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, cyamemazine, sulpiride, sultopride) , amisulpride, tiapride, pimozide, haloperidol, droperidol, veralipride), bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, lumefantrine, methadone, mizolastine, moxifloxacin, pentamidine, spiramycin IV, vincamine IV)

  • Higher risk of ventricular arrhythmias, especially torsades de pointes. Correct all hypokalemia before administering the product and perform clinical, electrolytic and electrocardiographic monitoring.

Rifampicin

  • Decreased plasma concentrations and efficacy of corticosteroids by increasing their hepatic metabolism with rifampicin; the consequences are particularly important for addisoners treated with hydrocortisone and for transplantation. Clinical and biological surveillance; Adjustment of corticosteroid dosage during rifampicin treatment and after discontinuation.

Gastrointestinal Topicals, Antacids and Charcoal (described for prednisolone, dexamethasone)

  • Decreased digestive absorption of glucocorticoids. Take topical gastrointestinal and antacid drugs away from glucocorticoids (more than 2 hours if possible).

Associations to consider

Antihypertensives

  • Decreased antihypertensive effect (water-soluble retention of corticosteroids).

Fluoroquinolones

  • Possible increase in the risk of tendonopathy or even tendon rupture (exceptional), particularly in patients receiving prolonged corticosteroid therapy.

Acetylsalicylic acid

  • Increased hemorrhagic risk.
  • To be taken into account with analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day).

Nonsteroidal anti-inflammatory drugs

  • Increased risk of ulceration and gastrointestinal bleeding.

Ciclosporin

  • Increased effects of prednisolone: ​​Cushingoid appearance, reduced carbohydrate tolerance (decreased clearance of prednisolone).

Warnings and Precautions

Special warnings

  1. In case of peptic ulcer, corticosteroid therapy is not contraindicated if anti-ulcer treatment is associated.
  2. In the case of an ulcerative history, corticosteroid therapy may be prescribed, with clinical monitoring and, if necessary, after fibroscopy.
  3. Corticosteroid therapy can promote the occurrence of various infectious complications due in particular to bacteria, yeasts and parasites. The occurrence of a malignant yellowing is a significant risk. All subjects from an endemic area (tropical, subtropical, southern Europe) should have parasitological examination of the stool and systematic eradication before corticosteroid therapy.
  4. Evidence of an infection may be masked by corticosteroid therapy.
  5. It is important, before the start of treatment, to rule out any possibility of visceral foci, especially tuberculosis, and to monitor, during treatment, the appearance of infectious pathologies.
  6. In case of old tuberculosis, prophylactic anti-tuberculosis treatment is necessary, if there are significant radiological sequelae and if one can not ensure that a good 6-month rifampicin treatment has been given.
  7. The use of corticosteroids requires particularly appropriate monitoring, especially in elderly patients and in cases of ulcerative colitis (risk of perforation), recent intestinal anastomoses, renal failure, hepatic insufficiency, osteoporosis, myasthenia gravis.
  8. Oral or injectable corticosteroids can promote the appearance of tendonopathy, or even tendon rupture (exceptional). This risk is increased when co-prescribed with fluoroquinolones and in dialysis patients with secondary hyperparathyroidism or renal transplantation.
  9. This medicinal product is not recommended in combination with a live attenuated vaccine or with anti-inflammatory doses of acetylsalicylic acid.
  10. This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Precautions for use

In case of long-term corticosteroid treatment:

  1. A diet low in fast-absorbing and high-protein sugars must be associated, because of the hyperglycemic effect and the protein catabolism with negativization of the nitrogen balance.
  2. Hydrosoduced retention is usual, partly responsible for a possible rise in blood pressure. This medicine contains sodium. This medicine contains 1.05 mmol (or 24 mg) of sodium per tablet. To be taken into account in patients on a strict sodium diet.
  3. Sodium intake will be reduced for daily dosages above 15 or 20 mg prednisone equivalent and moderate in long-term low-dose treatments.
  4. Potassium supplementation is warranted only for high-dose, long-term treatment or when there is a risk of rhythm disturbance or combination with hypokalaemic treatment.
  5. The patient must always have a calcium and vitamin D intake.
  6. When corticosteroid therapy is essential, diabetes and high blood pressure are not contraindications, but treatment can lead to imbalance. Their management needs to be re-evaluated.
  7. Patients should avoid contact with individuals with chickenpox or measles.
  8. Attention is drawn to athletes, this specialty containing an active ingredient that can induce a positive reaction tests conducted during anti-doping controls.

Drive and use machines

Not applicable.

 PREGNANCY / BREAST FEEDING / FERTILITY

solupred and pregnancy

  • This medication will only be used during pregnancy if necessary. If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue this treatment.

feeding

  • Breastfeeding should be avoided during treatment because of passage into breast milk.
  • Ask your doctor or pharmacist for advice before taking any medicine.

What happens if I overdose from Solupred ?

Not applicable.

What is  Forms and Composition ?

FORMS and PRESENTATIONS

Effervescent tablet 5 mg:   Bottle of 30. Effervescent tablet 20 mg:   Bottle of 20. Orodispersible 5 mg tablet:   Box of 30, in blister packs. Hospital model: Box of 50, in blister packs. 20 mg Orodispersible Tablet:  Box of 20, in blister packs. Hospital model: Box of 50, in blister packs. Oral solution 1 mg / ml:   50 ml bottle with child safety cap and dosing syringe (4 graduations: 0.5 ml, 1 ml, 1.5 ml, 2 ml).

COMPOSITION
Effervescent tablet : p cp
prednisolone 5 mg
or 20 mg
(as metasulfobenzoate sodium: 7.86 mg / cd at 5 mg, 32.416 mg / cp at 20 mg)

Excipients:

  • 5 mg Cp: tartaric acid, citric acid anhydrous, sodium bicarbonate, lithium benzoate, sucrose.
  • Cp 20 mg: tartaric acid, citric acid anhydrous, sodium bicarbonate, lithium benzoate, lemon natural flavor (maltodextrin, vegetable gum, sorbitol, lemon essential oil, citral, citronellal), sodium saccharin, silicone antifoam emulsion .

Excipients with known effect :

  • Cp at 5 mg: sodium (24 mg / cp), sucrose.
  • Cp at 20 mg: sodium (50.8 mg / cp), sorbitol.
Orodispersible tablet: p cp
prednisolone 5 mg
or 20 mg
(as metasulfobenzoate sodium: 7.86 mg / cp at 5 mg, 31.44 mg / cp at 20 mg)
  • Excipients (common): dispersion of 30% polyacrylate (Eudragit NE 30 D), hydrophobic colloidal silica (Aerosil R972), mannitol (granule), mannitol (powder), crospovidone, aspartame, magnesium stearate.
  • Excipient with known effect: aspartame.
Drinkable solution : p ml
prednisolone 1 mg
(as metasulfobenzoate sodium: 1.57 mg / ml)
  • Excipients: sodium cyclamate, glycerol, sorbic acid, sodium saccharinate, sorbitol (E420), sucrose, ethanol, purified water. Aroma: apricot (ethyl alcohol, vanillin, benzoic aldehyde, isoamyl acetate, diacetyl, ionone, allyl caproate, gamma undelactone, gamma nonalactone, levisticum tincture, essential oils of lemon, orange, bergamot, coriander , neroli, chamomile, cinnamon, nutmeg).
  • Excipients with known effect: sucrose, sorbitol (E420), ethanol.

1 ml of solution contains 30 mg of alcohol, 200 mg of sucrose and 150 mg of sorbitol (E420).

Alcoholic title: 4% (v / v).

NOT’s

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general information:

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Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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