Betnesol Uses, Dosage, Side Effects, Precautions & Warnings

why betnesol injection during pregnancy
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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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