debridat trimebutine Generic drug of the Therapeutic class: Gastro-Entero-Hepatology
active ingredients: Trimebutine

What is Debridat medication?

• This drug is indicated in the pains of digestive or biliary diseases.
• It corrects the associated transit disorders.

What is Debridat used for and indications?

Symptomatic treatment :

• Pain related to functional disorders of the digestive tract and bile ducts,
• Pain, transit disorders and intestinal discomfort related to intestinal functional disorders.

ANSM alert of 02/08/2017 :

• The indications are now limited to the symptomatic treatment of pain, transit disorders and intestinal discomfort related to intestinal functional disorders.

Debridat Dosage

Reconstitute the oral suspension by addition of non-carbonated mineral water to the mark on the vial.

Adult

• 1 graduation of the measuring cup of 15 ml, 3 times / day.
• Exceptionally this dosage can be increased up to 6 graduations of the measuring cup of 15 ml per day.

Child

In children under 5 years, it is recommended to use preferably Debridat Trimebutine CHILD AND NOURISHMENT 4.8 mg / ml, granulated for oral suspension in bottle, better suited to this age group.

However, the usual doses in children are:

• Up to 6 months: 1 graduation of the measuring cup of 2.5 ml, 2 to 3 times / day
• From 6 months to 1 year: 1 graduation of the measuring cup of 5 ml, 2 times / day
• From 1 to 5 years: 1 graduation of the measuring cup of 5 ml, 3 times / day
• Above 5 years: 1 graduation of the measuring cup of 10 ml, 3 times / day

about 1 graduation of the measuring cup of 5 ml per 5 kg of weight per day.

The suspension can be administered directly or mixed with a liquid.

Rinse the measuring cup carefully after use.

Debridat Contraindications

How it works Debridat

ANTISPASMODIC MUSCULOTROPE

ATC CODE: A03AA05

(A: digestive tract and metabolism)

1. The effects of trimebutine are exerted on the digestive tract on intestinal motility.
2. Trimebutine has enkephalinergic agonist properties. It stimulates intestinal motility by triggering propagated phase III waves of the migrating motor complex and inhibiting it during prior stimulation (in animals).
3. In vitro , it acts by blocking the sodium channels at a value (IC50 = 8.4 μM) and inhibits the release of a mediator of nociception (glutamate).
4. In the rat, it inhibits the animal’s reaction to rectal and colonic distension in different experimental models.

Debridat Side Effects

• The following list of adverse reactions is derived from the experience of clinical trials and data reported since marketing.
• According to the organ classification system, adverse reactions are listed below in order of frequency using the following categories: very common (≥1 / 10); frequent (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10000 to <1/1000); very rare (<1/10000); indeterminate frequency (can not be estimated based on available data).

Immune system disorders

Not known: hypersensitivity reactions (pruritus, urticaria, angioedema and exceptionally anaphylactic shock)

Skin and subcutaneous tissue disorders

Uncommon: rash

Frequency not known: generalized maculopapular rash, erythema, eczematiform reactions and exceptionally severe skin reactions including cases of generalized acute exanthematous pustulosis (PEAG), erythema multiforme, febrile toxidermia.

Debridat Interactions

Debridat Warnings and Precautions

Special warnings

• This medicine contains 3.7 g of sucrose per dose (per sachet) which must be taken into account in the daily ration in case of low sugar diet or diabetes.
• The use of this drug is not recommended in patients with intolerance to sucrose (rare hereditary disease).
• This medicine contains an azo coloring agent (E110) and may cause allergic reactions.

Precautions for use

• This form is not suitable for children under 5 years old.
• In case of diabetes, take into account the sugar content: 3.7 g of sucrose per sachet.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Effects on ability to Drive and use machines

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

PREGNANCY / BREAST FEEDING / FERTILITY

debridat pregnancy

Breastfeeding

What happens if I overdose from Debridat ?

IN CASE OF OVERDOSAGE, CONSULT YOUR DOCTOR.

What happens if you stop taking Debridat ?

If you stop taking DEBRIDAT 200 mg/100 mg film-coated tablet:

Not applicable.

What is  Forms and Composition?

Film-coated tablet 100 mg (white) and 200 mg (white):

•   Boxes of 30, in blister packs. Granules for oral suspension:   250 ml bottle (brown glass type III) containing 152.5 g of granules, with cup (polypropylene) graduated to 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml. Sachets, box of 30.
• Injection solution (IM or IV) 50 mg / 5 ml:   Ampoules (colorless glass) 5 ml, box of 25.
  

Meteospasmyl Capsules Generic drug of the Therapeutic class: Gastro-Entero – Hepatology
active ingredients: Alverine , Simeticone

What is MeteoSpasmyl drug used for and indication?

Symptomatic treatment of intestinal functional manifestations, particularly with meteorism.

Meteospasmyl Capsules Dosage

• Oral way.RESERVED FOR ADULTS1 capsule 2 to 3 times a day at the beginning of meals or at the time of pain.

Contraindications

meteospasmyl mechanism of action

Pharmacotherapeutic group: ANTISPASMODIC MUSCULOTROPE / ANTIFLATULENT

ATC Code: A03AX08 – Other Medications for Gastrointestinal Functional Disorders

• Alverine citrate is a musculotropic anti-spasmodic.
• Simeticone is a physiologically inert substance and therefore has no pharmacological activity. It acts by modifying the surface tension of the gas bubbles thus causing their coalescence.

How To Store meteospasmyl ?

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 package after EXP. The expiration date refers to the last day of that month.

PVC / Aluminum pads

• Store at a temperature not exceeding 30 ° C.

PVC / PE / PVDC-Aluminum pads

• No special storage conditions.

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.

Meteospasmyl Side Effects

Due to the presence of alverine:

• rare cases of urticaria, sometimes with laryngeal edema, shock,
• rare cases of regressive liver damage at the end of treatment.

Meteospasmyl drug Interactions

Warnings and Precautions

Liver function:

• Increases in ALT (Alanine Aminotransferase) and ASAT (Aspartate Aminotransferase)> 2 times the upper limit of normal (ULN) have been reported in patients receiving alverine / simeticone therapy. These increases may be associated with a concomitant elevation of total serum bilirubin.
•  If hepatic aminotransferases increase by> 3 times the ULN, and even more so in cases dictere, treatment with alverine / simeticone should be discontinued.

Drive and use machines

• Prevent drivers of vehicles and machinery users from the risk of drowsiness, amnesia or impaired muscle concentration or function.
• The combination with other sedative drugs should be discouraged or taken into account when driving or using machines.

If sleep time is insufficient, the risk of impaired alertness is further increased.

Meteospasmyl Capsules and Pregnancy / Breastfeeding

meteospasmyl during pregnancy

• Many data from cohort studies have not revealed the occurrence of malformative effects during benzodiazepine exposure during the course of 1
• ^first  trimester of pregnancy. However, in some case-control epidemiological studies, an increase in the occurrence of cleft lip and palate has been observed with benzodiazepines. According to these data, the incidence of cleft lip and palate in newborns would be less than 2/1000 after exposure to benzodiazepines during pregnancy while the expected rate in the general population is 1/1000.
• If benzodiazepines are taken in high doses at 2 ^nd and / or 3 ^rd trimesters of pregnancy, a decrease in fetal active movements and a variability in fetal heart rate have been described.
• Treatment with benzodiazepines at the end of pregnancy, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders resulting in low weight gain.
• These signs are reversible, but can last 1-3 weeks depending on the half-life of the prescribed benzodiazepine. At high doses, respiratory depression or apnea, and hypothermia may occur in the newborn. In addition, a neonatal withdrawal syndrome is possible, even in the absence of signs of impregnation.
• It is characterized in particular by hyperexcitability, agitation and tremulations of the newborn occurring at a distance from the delivery.
• The time of onset depends on the elimination half-life of the drug and may be important when it is long.
• Based on these data, as a precautionary measure, the use of alprazolam is not recommended during pregnancy, regardless of the term.
• When prescribing alprazolam to a woman of childbearing potential, she should be advised of the need to contact her physician if pregnancy is planned or initiated to re-assess the benefit of the treatment.
• At the end of pregnancy, if it is really necessary to start a treatment with alprazolam, avoid prescribing high doses and take into account, for surveillance of the newborn, effects previously described.

Breastfeeding

What happens if I overdose from Meteospasmyl ?

What is  Forms and Composition Meteospasmyl Capsules?

• 0.25 mg scored tablet:  Box of 30, in blister packs.

• Hospital model: Box of 100. 0.50 mg scored tablet:  Box of 30, in blister packs. Hospital model: Box of 100. Breakable tablet 1 mg:  Box of 100, in blister packs.

Excipients (common): lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, mixture of sodium docusate (85%) and sodium benzoate (15%), corn starch, magnesium stearate, aluminum erythrosine lake (cp 0 , 50 mg and 1 mg), indigo aluminum lake (cp 1 mg).

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.

nexium Generic drug of the therapeutic class: Stomach Medicines
active principles: esomeprazole

what is nexium?

• Esomeprazole reduces the production of acid in the stomach.
• In case of upset stomach (heartburn, pain due to rising stomach acid or bloating with nausea), ulcers, duodenal ulcers and in Zollinger-Ellison syndrome (rare stomach disease with many stomach complaints). Also to prevent stomach problems if you use medications that can damage the stomach.
• Works within 1 to 2 hours and about 12 hours long. The damage will begin to heal within a few days. You will then suffer less from your stomach.
• Tablets and capsules : take without chewing. Do you have difficulty swallowing? You can disintegrate the tablet into half a glass of tap water. Open the capsule and put the granules in half a glass of tap water. Stir and drink. Swallow the granules through.
• Bags: sprinkle the grains in half a glass of tap water. Stir and drink. Do not chew on grains.
• How long you should use esomeprazole depends on your condition. Sometimes you have to use it for a long time to prevent a return of your symptoms. Do you take it against stomach problems due to medication? You only have to take esomeprazole on the days when you are using the stomach-damaging medicine.
• You may become nauseous, dizzy or sleepy. You may also experience abdominal pain or headaches. Do you suffer from these side effects? Consult your doctor.
• There are interactions with other means. Ask your pharmacist if you can use esomeprazole safely with your other medicines, including medicines that you have purchased without a prescription.

what is nexium used for and indication?

Nexium Control is indicated for the short-term treatment of symptoms of gastroesophageal reflux (eg, heartburn and acid regurgitation) in adults.

Nexium Dosage

nexium 20 mg dose

1. The recommended dose is 20 mg esomeprazole (one tablet) daily.
2. Taking tablets for 2 or 3 consecutive days may be necessary to improve symptoms. The duration of treatment can be up to 2 weeks. Once the symptoms are gone, treatment should be stopped.
3. If symptoms persist after 2 weeks of continuous treatment, the patient should be advised to consult a physician.

Specific populations

Patients with renal insufficiency

• No dosage adjustment is necessary in patients with renal impairment.
• Patients with severe renal impairment should be treated with caution because of limited experience in these patients .

Patients with hepatic impairment

• No dose adjustment is required in patients with mild to moderate hepatic impairment. However, patients with severe hepatic impairment should be advised by a physician before taking Nexium Control (see Warnings and Precautions and Pharmacokinetic Properties sections ).
• Seniors (≥ 65 years old)
• No dose adjustment is required in elderly patients.

Pediatric population

There is no justified use of Nexium Control in the pediatric population under 18 years of age in the indication: “short-term treatment of symptoms of gastroesophageal reflux (eg, heartburn and acid regurgitation)”.

Administration mode

The tablets should be swallowed whole with half a glass of water. The tablets should not be chewed or chewed.

Moreover, the tablet can be disintegrated in half a glass of non-carbonated water. No other liquid should be used as the enteric coating can be dissolved. Mix the solution until the tablet is disintegrated. The solution with the granules should be ingested immediately or within 30 minutes. The glass should be rinsed with half a glass of water and the water should be ingested. The granules should not be chewed or chewed.

Contraindications

how does nexium work

Pharmacotherapeutic group: Drugs for acidity disorders, proton pump inhibitors.

ATC Code: A02B C05.

Esomeprazole is the S-isomer of omeprazole and decreases acidic gastric secretion by a specifically targeted mechanism of action. It is a specific inhibitor of the proton pump at the level of the parietal cell. Both R and S isomers of omeprazole have similar pharmacodynamic activity.

Action mechanism

• Esomeprazole is a weak base. It is concentrated and converted into an active form in the highly acidic environment of secretory canaliculi of the parietal cell, where it inhibits the enzyme H + K + -ATPase (the proton pump), basal acid secretion and stimulated acid secretion.

Pharmacodynamic effects

• After oral administration of 20 mg and 40 mg esomeprazole, the effect occurs within one hour. After repeated administration of 20 mg esomeprazole once daily for 5 days, the acid medium peak obtained after stimulation by pentagastrin decreases by 90% in the 5 ^th day, 6-7 hours after dosing.
• After 5 days of oral doses of 20 mg and 40 mg of esomeprazole, an intragastric pH greater than 4 was maintained for an average of 13 hours and 17 hours over 24 hours, respectively, in patients with symptomatic gastroesophageal reflux disease (GERD). The percentages of patients whose intragastric pH remained above 4 for at least 8, 12 and 16 hours after 20 mg of esomeprazole were 76%, 54% and 24%, respectively. With a dose of 40 mg, the corresponding percentages were 97%, 92% and 56%.
• Using the area under the curve as a parameter reflecting plasma concentration, a relationship between acid secretion inhibition and exposure has been demonstrated.
• During antisecretory treatment, serum gastrin concentration increases in response to reduced acid gastric secretion. CgA also increases because of the decrease in gastric acidity.
• An increase in the number of ECL cells in relation to the increase in serum gastrin concentrations has been observed in some long-term patients treated with esomeprazole.
• The reduction of gastric acidity, whatever the cause, especially that induced by proton pump inhibitors IPPs, increases in the stomach the number of bacteria that are normally found in the digestive tract. IPPs treatment may slightly increase the risk of gastrointestinal infections caused by germs such as Salmonella and Campylobacter and possibly by Clostridium difficile in hospitalized patients.

Clinical efficiency

• Esomeprazole 20 mg has been shown to effectively treat frequent heartburn in subjects receiving a 24-hour dose for 2 weeks. In two pivotal, randomized, double-blind, placebo-controlled, multicenter studies, 234 subjects with recent history of frequent heartburn were treated with 20 mg esomeprazole for 4 weeks.Symptoms associated with acid reflux (such as heartburn and acid regurgitation) were evaluated retrospectively over a 24-hour period. In both studies, esomeprazole 20 mg was significantly more effective than placebo on the primary endpoint, the complete resolution of heartburn defined by the absence of burns.
• The other secondary endpoints were consistent with the primary endpoint, including heartburn relief at weeks 1 and 2, the percentage of 24-hour days without heartburn at weeks 1 and 2, the mean stomach at weeks 1 and 2 and the time to first resolution and lasting resolution of heartburn over a 24-hour period and during the night, compared with placebo. Approximately 78% of subjects receiving esomeprazole 20 mg reported a first resolution of heartburn during the first week of treatment versus 52% to 58% of subjects on placebo. The time to obtain a lasting resolution of heartburn, defined by 7 consecutive days without burning of stomach since the first observation of heartburn, was significantly shorter in the group receiving 20 mg of esomeprazole (39.7% – 48.7% at day 14 vs 11.0% – 20.2% under placebo) . The median time to first resolution of nocturnal heartburn was 1 day, this value was statistically significant compared to placebo in one study (p = 0.048) and close to the significance in the other (p = 0.069). About 80% of the nights were heartburn free during all periods and 90% of the nights were heartburn-free the second week of each trial, compared to 72.4% to 78.3% for the placebo.The evaluation of the resolution of heartburn by the investigators was consistent with that of the subjects, with statistically significant differences between esomeprazole (34.7% – 41.8%) and placebo (8.0% – 11.4%). The investigators also found that esomeprazole was significantly more effective than placebo in resolving acid regurgitations (58.5% – 63.6% vs. 28.3% – 37.4% for placebo) during the evaluation. 2 weeks.
• As a result of the overall therapeutic evaluation of patients at week 2, 78.0% – 80.7% of patients receiving esomeprazole 20 mg, compared to 72.4% – 78.3% of patients receiving placebo, reported that their state of health was improved. The majority of them felt the importance of this change from Important to Extremely Important in carrying out their activities of daily living (79% – 86% at week 2).

What are the bad side effects of Nexium?

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

The main side effects are the following.

Rarely (from 1 to 10 in 100 people)

• Gastrointestinal complaints such as nausea, vomiting, abdominal pain, diarrhea, constipation and flatulence.
• Headache .
• Irritation at the injection site , especially at high doses .

Very rare (affects less than 1 in 100 people)

• Dizziness and drowsiness .
• Itching, skin rash, sweating and hair loss . If you stop this medication, these side effects will go over again.
• Blurred vision or double vision, sensory disturbances and fluid retention in the legs. If you stop this medication, these side effects will go over again.
• Confusion , depression and hallucinations in the elderly. If you stop this medication, these side effects will go over again.
• Hypersensitivity to this medication. You can then get skin rash, hives or itching. In rare cases, fever, swollen lips, tongue or face, tightness , fainting, or severe skin abnormality develop. Then discontinue use and consult your doctor. You may not use this medicine in the future. Therefore, tell the pharmacist that you are hypersensitive to esomeprazole. The pharmacy team can then ensure that you do not get this medication again.
• In the man: breast formation and impotence . These side effects will pass if you stop taking this medicine. Contact your doctor if you suffer from this.
• Complaints of the mouth and throat , such as dry mouth and throat, mouth ulcers and inflammation of the oral mucosa. You notice this with a scarlet color of the mucous membranes, painful tongue or throat. Eating and drinking can be painful because of this. Also taste changes occur. Take good care of your mouth and teeth. Consult your doctor if you continue to suffer from this
• Inflammation of the kidneys or liver and blood disorders . Tell your doctor one or more of the following symptoms: sudden severe upper abdominal pain, jaundice, unexplained bruising, extreme fatigue or sore throat with fever and blisters in the throat.
• Bone fractures or fractures in the vertebrae. Contact your doctor if you suffer from this.
• Deficiency of potassium , a specific substance in the blood. You notice this first with muscle weakness, muscle cramps or muscle pain usually first in the thighs and arms, severe fatigue, palpitations , severe abdominal complaints. If you have diarrhea or vomiting a lot, contact your doctor.
• Heart rhythm disorders. You sometimes only notice this by sudden dizziness or if you just get lost. Especially people with the congenital form of cardiac arrhythmiaprolonged QT interval are more likely. Do NOT use this medicine if you have this congenital heart rhythm disorder .

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.

nexium drug interactions

Interaction studies were performed in adults only.

nexium interactions with other medications

Since esomeprazole is an enantiomer of omeprazole, interactions reported with omeprazole should be considered.

Protease inhibitors

• An interaction between omeprazole and some protease inhibitors has been reported. The clinical importance and mechanisms of these interactions are not always known. Increased gastric pH when treated with omeprazole may alter the absorption of protease inhibitors. There are other possible mechanisms of interactions that occur via inhibition of CYP2C19.
• For atazanavir and nelfinavir, decreased plasma concentrations of these drugs have been reported when administered concomitantly with omeprazole; Concomitant administration of omeprazole and these drugs is therefore not recommended. Concomitant administration of omeprazole (40 mg, once daily) with atazanavir 300 mg / ritonavir 100 mg in healthy volunteers resulted in a substantial decrease in atazanavir plasma concentrations (a decrease in about 75% of AUC, C _max and C _min). The increase in dosage of atazanavir to 400 mg did not offset the effect of omeprazole on the plasma concentrations of atazanavir. Concomitant administration of omeprazole (20 mg once daily) and atazanavir 400 mg / ritonavir 100 mg in healthy volunteers resulted in approximately a 30% decrease in exposure to atazanavir compared with exposure observed after administration of atazanavir 300 mg / ritonavir 100 mg once daily, without omeprazole 20 mg once daily. Concomitant administration of omeprazole (40 mg once daily) decreased nelfinavir AUC, C _max,and C _min by 36 to 39%, and mean the SC,of its pharmacologically active metabolite M8. Due to the similarity of the pharmacodynamic and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration of esomeprazole and atazanavir is not recommended and co-administration of esomeprazole and nelfinavir is contraindicated (see sections Contraindications and Warnings and Precautions for Use ).
• For saquinavir (in combination with ritonavir), an increase in plasma concentration (from 80 to 100%) has been reported during concomitant treatment with omeprazole (40 mg once daily). Treatment with omeprazole 20 mg once daily did not affect exposure to darunavir (ritonavir-associated) or amprenavir (ritonavir-associated).
• Treatment with esomeprazole 20 mg once daily did not affect exposure to amprenavir (with or without ritonavir).Treatment with omeprazole 40 mg once daily did not affect exposure to lopinavir (ritonavir-associated).

methotrexate

• An increase in methotrexate concentrations has been observed in some patients when concomitant administration of methotrexate with proton pump inhibitors (PPIs). When administering high doses of methotrexate, temporary discontinuation of esomeprazole may be necessary.

tacrolimus

• Increases in serum tacrolimus have been reported with concomitant use of tacrolimus and esomeprazole.Enhanced monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be performed and the dosage of tacrolimus should be adjusted as needed.

Drugs whose absorption is pH dependent

Inhibition of gastric acid during treatment with esomeprazole and other IPPs may decrease or increase drug absorption if it is dependent on gastric pH. Absorption of oral medications such as ketoconazole, itraconazole and erlotinib may decrease during treatment with esomeprazole and absorption of digoxin may increase during treatment with esomeprazole.

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two of the ten subjects). Toxicity of digoxin has been reported rarely. However, special attention should be paid when esomeprazole is given in high doses in elderly patients.Monitoring of treatment with digoxin should therefore be strengthened.

Drugs metabolised by CYP2C19

Esomeprazole inhibits CYP2C19, the major metabolizing enzyme of esomeprazole. Therefore, when co-administered with CYP2C19-mediated drugs, such as warfarin, phenytoin, citalopram, imipramine, clomipramine, diazepam, etc., the plasma concentrations of these drugs may be increased and dose reduction may be necessary. In the case of clopidogrel, a prodrug converted to its active metabolite via CYP2C19, plasma concentrations of the active metabolite may be decreased.

warfarin

• A clinical trial has shown that when co-administered with 40 mg esomeprazole in patients treated with warfarin, clotting times remain within normal range. However, since marketing, only isolated cases of clinically significant INR elevations have been reported during concomitant treatment. Monitoring is recommended at initiation and at the end of concomitant treatment of esomeprazole with warfarin or other coumarin derivatives.

clopidogrel

• The results of studies in healthy subjects showed a pharmacokinetic (PK) / pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose followed by 75 mg daily maintenance dose) and esomeprazole (40 mg per day orally) resulting in a decrease in exposure to the active metabolite of clopidogrel by an average of 40% and a decrease in the maximum inhibition of platelet aggregation (ADP-induced) by an average of 14%.
• In a study in healthy subjects, a decrease in the exposure of approximately 40% of the active metabolite of clopidogrel was observed when taking a fixed combination of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg with clopidogrel in comparison with clopidogrel alone. However, the maximum levels of inhibition of platelet aggregation (ADP-induced) in these patients were identical in both groups.
• Contradictory data on the clinical consequences of this PK / PD interaction in terms of the occurrence of major cardiovascular events have been reported in observational and clinical studies. As a precaution, the concomitant use of esomeprazole and clopidogrel should be discouraged.

phenytoin

• Co-administration of 40 mg esomeprazole leads to a 13% increase in plasma phenytoin concentrations in epileptic patients. It is recommended to monitor the plasma concentrations of phenytoin when starting or stopping treatment with esomeprazole.

voriconazole

• Omeprazole (40 mg once daily) increased plasma concentrations of voriconazole (a CYP2C19 substrate) with C _max and AUCτ increased by 15% and 41%, respectively.

cilostazol

• Like omeprazole, esomeprazole is an inhibitor of CYP2C19. In a cross-over study, omeprazole administered at 40 mg to healthy subjects increased C _max and cilostazol AUC by 18 and 26%, respectively, and one of its active metabolites of 29 and 69% respectively.

cisapride

• In healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in a 32% increase in plasma AUC and a 31% prolongation of the elimination half-life. (t _1/2 ) without a significant increase in the plasma peak of cisapride. The slight prolongation of the QTc interval observed after administration of cisapride alone is not increased when cisapride is co-administered with esomeprazole.

diazepam

• Concomitant administration of 30 mg esomeprazole resulted in a 45% decrease in clearance of the CYP2C19-metabolized diazepam metabolite.

Drugs without clinically significant interaction

Amoxicillin and quinidine

• Esomeprazole did not show a clinically relevant effect on the pharmacokinetics of amoxicillin and quinidine.

Naproxen or rofecoxib

• Short-term studies evaluating co-administration of esomeprazole with naproxen or rofecoxib have not shown a clinically significant pharmacokinetic interaction.

Effects of other drugs on the pharmacokinetics of esomeprazole

Drugs that inhibit CYP2C19 and / or CYP3A4

Esomeprazole is metabolized by CYP2C19 and CYP3A4. Concomitant administration of esomeprazole with a CYP3A4 inhibitor, clarithromycin (500 mg twice daily), leads to a doubling of exposure (AUC) to esomeprazole.Concomitant administration of esomeprazole and a combination inhibitor of CYP2C19 and CYP3A4 may result in an increase of more than double the exposure to esomeprazole. Voriconazole, an inhibitor of CYP2C19 and CYP3A4, resulted in an increase in AUCτ of omeprazole by 280%. A systematic dose adjustment of esomeprazole is not required in either of these situations. However, dose adjustment should be considered in patients with severe hepatic impairment,

Drugs that induce CYP2C19 and / or CYP3A4

Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s Wort ( Hypericum perforatum )) can lead to decreased serum esomeprazole levels by increasing the metabolism of esomeprazole.

Nexium Warnings and Precautions

General

Patients are advised to take medical advice in case of:

• significant and unintentional weight loss, repeated vomiting, dysphagia, haematemesis or melena, and if there is suspicion or presence of a gastric ulcer, the possibility of malignancy should be excluded as treatment with esomeprazole may reduce symptoms and delay the diagnosis.

• history of gastric ulcer or digestive surgery.

• Continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more.

• jaundice or severe liver disease.

• new symptoms or recent changes in symptoms in patients over 55 years of age

Patients with persistent and relapsing disorders such as difficult digestion (dyspepsia) or heartburn (heartburn) should consult their doctor regularly. Patients over the age of 55 who take daily non-prescription medications due to difficult digestion or heartburn should inform their pharmacist or doctor. 

Patients should not take Nexium Control as a long-term preventative medicine. 

Treatment with proton pump inhibitors (PPIs) may lead to a slight increase in the risk of gastrointestinal infections, including Salmonella and Campylobacter, and possibly Clostridium difficile in hospitalized patients .

Patients should consult their physician before taking this medication if an endoscopy or urea breath test is planned. 

Association with other drugs

• The combination of esomeprazole with atazanavir is not recommended (see section Interactions with other medicinal products and other forms of interaction ). If the combination of atazanavir with a proton pump inhibitor is considered essential, close clinical monitoring is recommended, together with an increase in the dose of atazanavir 400 mg with 100 mg ritonavir. A dose of 20 mg esomeprazole should not be exceeded. 
• Esomeprazole is an inhibitor of CYP2C19. At the beginning or end of treatment with esomeprazole, the risk of interactions with drugs metabolized by CYP2C19 should be considered. An interaction between clopidogrel and esomeprazole was observed. The clinical relevance of this interaction is uncertain. Concomitant use of esomeprazole and clopidogrel should be discouraged. 
• Patients should not take another PPI or H ₂ concomitantly. 

Sucrose

• This medicine contains spheres of sugar (sucrose). It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase / isomaltase deficiency.

Interference with laboratory tests

• Increased levels of Chromogranin A (CgA) may interfere with tests performed for the exploration of neuroendocrine tumors. In order to avoid this interference, treatment with esomeprazole should be stopped for 5 days before the determination of CgA.
• Subacute cutaneous lupus erythematosus (LECS)
• Inhibitors of the proton pump are associated with very infrequent cases of LECS. If lesions develop, especially on sun-exposed skin areas, and if accompanied by arthralgia, the patient should seek medical attention promptly and the healthcare professional should consider stopping Nexium Control. The occurrence of a LECS after treatment with a proton pump inhibitor may increase the risk of LECS with other proton pump inhibitors.

Drive and use machines

Esomeprazole has a minor influence on the ability to drive or use machines. Side effects such as dizziness and visual disturbances are uncommon ( see section 4.8 ). Patients with these types of side effects should not drive or use machines.

Nexium and PREGNANCY / BREAST FEEDING / FERTILITY:

Nexium in Pregnancy

• A moderate number of data in the pregnant woman (between 300-1000 pregnancy results) showed no malformative or toxic effects for the fetus or newborn with esomeprazole. Studies in animals have not shown any direct or indirect harmful effects on reproduction (see section 5.3 ).
• As a precaution, it is best to avoid the use of Nexium Control during pregnancy.

Nexium in feeding

• It is not known whether esomeprazole / metabolites are excreted in breast milk. There is insufficient data on the effects of esomeprazole in newborns / infants. Esomeprazole should not be used during breastfeeding.

Nexium in Fertility

• Animal studies with the racemic mixture of omeprazole administered orally do not indicate an effect on fertility.

What should I do if nexium missed 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 Nexium ?

To date, experience with voluntary overdose is very limited.

The symptoms described when taking 2 80 mg are gastrointestinal symptoms and signs of fatigue.

Single doses of 80 mg esomeprazole were well tolerated.There is no known specific antidote.

Esomeprazole is highly bound to plasma proteins and therefore not easily dialyzable. In case of overdose, appropriate symptomatic treatment should be initiated.

What is  Forms and Composition Nexium?

Enteric coated film-coated tablet 20 mg (14 mm x 7 mm, pale pink, oblong, biconvex, engraved “20 mg” on one side and “A / EH” on the other side):  Boxes of 7 and 14.

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.

forlax Generic drug of the Therapeutic class: Gastro-Entero–Hepatology
active ingredients: Macrogol 4000

Important to know about FORLAX ?

• FORLAX is indicated for the treatment of constipation in adults and children over 8 years of age.
• This medicine is in the form of a powder that must be dissolved in a glass of water (at least 50 ml) and drink. Its effect usually occurs in 24 hours to 48 hours.
• The treatment of constipation with a drug must be associated with rules of lifestyle and a healthy diet.

what is forlax used for  and indication?

• Symptomatic treatment of constipation in adults and children from 8 years.
• An organic cause should be discarded before initiating treatment. FORLAX 10 g should remain a temporary treatment of constipation, lasting no more than 3 months in children, in combination with appropriate dietary measures.
• The persistence of the disorders in spite of the combined hygienic and dietary measures will have to seek out and treat an underlying pathology.

FORLAX Dosage

Oral way.

1. The dosage is 1 to 2 sachets per day, preferably in a single dose in the morning.
2. The contents of each sachet should be dissolved in a glass of water just before administration.
3. The effect of FORLAX occurs within 24 to 48 hours of administration.
4. In children, in the absence of clinical data beyond 3 months, the duration of treatment should not exceed 3 months.
5. Improvement of the intestinal transit induced by the treatment will be maintained by hygienic and dietary measures.
6. The daily dose should be adapted according to the clinical effects obtained and can range from 1 sachet every other day (especially in children) to 2 sachets per day.

Contraindications

Severe inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or toxic megacolon, associated with symptomatic stenosis,

Digestive perforation or risk of digestive perforation,

Ileus or suspected intestinal obstruction,

Painful abdominal syndromes of unknown cause

Hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients.

How it works?

Pharmacokinetic data confirm the absence of digestive resorption and biotransformation of macrogol 4000 after oral ingestion.

FORLAX Side Effects

The frequency of adverse reactions can be classified as follows:

• Very common ( > 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10 000 to <1/1000) ), very rare (<1 / 10,000), not known (can not be estimated from the available data).

In adults:

The side effects listed in the table below have been reported in clinical studies (including approximately 600 patients) and in product marketing. In general, these side effects have always been minor and transient, and mainly concerned the digestive system:

In children:

The undesirable effects listed in the table below have been reported in clinical trials involving 147 children aged 6 months to 15 years of age and when marketing the product. As with adults, these side effects have generally been minor and transient and mainly involved the digestive system:

* Diarrhea can cause perianal pain.

FORLAX Interactions

FORLAX Warnings and Precautions :

Special warnings

Medication treatment of constipation is only an adjunct to the hygienic and dietary treatment such as:

• · Enrichment of the vegetable fiber and beverage feed,
• · Adapted physical activity and re-education of the exemption.
• An organic cause must be discarded before initiating treatment.

This medicine contains macrogol (polyethylene glycol). Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) have been reported with specialties containing macrogol, .

This medicine contains sulfur dioxide and in rare cases can cause severe allergic reactions and bronchospasm.

This drug contains sorbitol. Its use is not recommended in patients with fructose intolerance (rare hereditary disease).

In case of diarrhea, patients at risk of fluid and electrolyte imbalance (eg, subject, patient with hepatic impairment or renal failure or diuretic therapy) should be monitored and electrolyte control should be considered.

Cases of inhalation have been reported during nasogastric tube administration of large volumes of polyethylene glycol and electrolytes. Children with neurological involvement with oromotor disorders are particularly exposed to this risk of inhalation.

Special precautions for use

Because FORLAX does not contain a significant amount of sugar or polyol, it can be prescribed to diabetic patients or to patients on a galactose-free diet.

Drive and use machines

Not applicable.

FORLAX and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy

• Studies in animals have not shown any direct or indirect harmful effects on reproduction.
• There is limited data (less than 300 pregnancies) on the use of Forlax in pregnant women.
• No effects during pregnancy are expected as systemic exposure to Forlax is negligible.
• Forlax can be used during pregnancy.

Breastfeeding

• There are no data on the excretion of Forlax in breast milk.
• No effects in breastfed newborns / infants are expected as the systemic exposure of the woman who is breastfeeding at Forlax is negligible. Forlax can be used while breastfeeding.

Fertility

• No fertility studies have been performed with Forlax. However, since macrogol 4000 is not absorbed significantly, no effect on fertility is expected.

What should I do if I miss a dose?

Take the dose but do not double it to make up for the dose you forgot to take.

What happens if I overdose from?

• Taking too much FORLAX can cause diarrhea, which usually disappears when treatment is stopped or the dose is reduced.
• If you have severe diarrhea or vomiting you should contact a doctor as soon as possible because you may need treatment to prevent loss of salts (electrolytes) due to fluid loss.

What is  Forms and Composition?

• Powder for oral solution (with a smell and taste of orange and grapefruit, white to whitish):   Sachets, box of 20.

• Excipients: saccharin sodium (E 954), orange grapefruit flavor (including sorbitol [E 420] and sulfur dioxide [E 220]).

^*  PEG 4000 or polyethylene glycol 4000

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.

Inexium drug >>> generic drug of the Therapeutic class: Gastro-Entero – Hepatology
active ingredients: Esomeprazole

Important to know about Inexium?

Inexium (Esomeprazole) 40 mg gastro-resistant tablet is used in the treatment of the following diseases:

• The treatment of reflux erosive esophagitis when stomach acid rises up to the esophagus and causes pain, inflammation and burns.
• Excess acid in the stomach due to Zollinger-Ellison syndrome.
• Continuation of the treatment after prevention with intravenous Inexium (Esomeprazole) of the haemorrhagic recurrence of a peptic ulcer.

Inexium indication and Uses

Inexium Dosage

adults

Gastroesophageal reflux disease (GERD):

• Treatment of erosive reflux oesophagitis 40 mg once a day for 4 weeks.
• An additional treatment of 4 weeks is recommended in patients whose esophagitis is not healed or whose symptoms persist.

Treatment of Zollinger-Ellison syndrome

The recommended starting dose is 40 mg twice daily. The dosage should be adjusted individually and treatment continued as long as clinically necessary. Based on the available clinical data, the majority of patients are controlled with doses between 80 and 160 mg deomeprazole daily. For dosages above 80 mg daily, the daily dose should be divided and given in 2 doses.

Continuing treatment after intravenous prevention of haemorrhagic recurrence of peptic ulcer

40 mg once daily for 4 weeks after intravenous prevention of haemorrhagic recurrence of peptic ulcer.

Special populations

Renal failure

• No dosage adjustment is necessary in case of renal insufficiency.
• Due to limited experience in patients with severe renal impairment, the use of dInexium (Esomeprazole) should be cautious in these patients.

Hepatic insufficiency

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. The maximum dose of 20 mg of INInexium (Esomeprazole) should not be exceeded in patients with severe hepatic impairment.

Elderly

• No dose adjustment in the elderly.

Pediatric population

• Teenagers from the age of 12

Gastroesophageal reflux disease (GERD):

• Treatment of reflux erosive oesophagitis 40 mg once a day for 4 weeks.
• An additional 4-week treatment is recommended in patients whose osteoarthritis is not healed or whose symptoms persist.

Children under 12 years

• Inexium (Esomeprazole) should not be used in children under 12 years of age in the absence of available data.
• For the dosage of patients aged 1 to 11 years, refer to the SPINE dInexium (Esomeprazole) sachet.

Administration mode

• The tablets should be swallowed whole with a drink. They must not be chewed or chewed.
• In patients who have difficulty swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquid should be used as the gastroenteric coating may be dissolved. Stir until tablets break and drink solution with granules immediately or within 30 minutes. Rinse the glass with half a glass of water and drink it. Granules should not be chewed or chewed.
• For patients who can not swallow, the tablets can be dispersed in non-aerated water and administered by gastric tube.
• It is important to make sure beforehand and thoroughly that the chosen probe and syringe are appropriate.
• For preparation and administration by gastric tube.

Contraindications

Known hypersensitivity to esomeprazole, to benzimidazole derivatives or to any of the ingredients.

•  Esomeprazole, like other proton pump inhibitors, should not be administered with atazanavir ( see section Interactions with other medicinal products and other forms of interactions ).
• Esomeprazole must not be used concomitantly with nelfinavir (see section Interactions with other medicinal products and other forms of interactions ).

How it works Inexium

Pharmacotherapeutic group: Drugs for acidity disorders, PROTON INHIBITORS, ATC code: A02B C05

• Esomeprazole is the S- isomer of omeprazole and decreases acidic gastric secretion by a specifically targeted mechanism of action. It is a specific inhibitor of the proton pump at the level of the parietal cell. Both R and S isomers of omeprazole have similar pharmacodynamic activity.

Action mechanism

• Esomeprazole is a weak base. It is concentrated and converted into an active form in the acidic environment of secretory canaliculi of parietal cells, where it inhibits the enzyme H + K + -ATPase (the proton pump), basal acid secretion and stimulated acid secretion.

Pharmacodynamic effects

• After an oral dose of 20 and 40 mg of esomeprazole, the onset of anti-secretory effect occurs within one hour. After repeated administration of 20 mg of esomeprazole once daily for 5 days, the maximum flow rate obtained after acid stimulation by pentagastrin is reduced on average by 90% in the 5 ^th day, 6 to 7 hours after dosing.
• After 5 days of oral doses of 20 mg and 40 mg of esomeprazole, an intragastric pH greater than 4 was maintained for an average of 13 and 17 hours in 24 hours in patients with symptomatic gastroesophageal reflux. The percentages of patients with pH> 4, for at least 8, 12 and 16 hours are respectively 76%, 54% and 24% with 20 mg of esomeprazole and 97%, 92% and 56% with 40 mg esomeprazole.
• Using the area under the curve (AUC) as a parameter reflecting plasma concentration, a relationship between acid gastric secretion inhibition and area under the curve (AUC) has been demonstrated.
• Healing of reflux esophagitis with esomeprazole 40 mg was achieved in approximately 78% of patients after 4 weeks of treatment and in 93% of patients after 8 weeks of treatment.
• One week of treatment with esomeprazole 20 mg twice daily with appropriate antibiotics results in eradication of Helicobacter pylori in approximately 90% of patients.
• After a week-long eradication treatment, it is not necessary to continue anti-secretory monotherapy to obtain healing and disappearance of symptoms in uncomplicated duodenal ulcer.
• In a randomized, double-blind, placebo-controlled clinical trial, patients with endoscopically-confirmed gastroduodenal ulcer bleeding (Forrest Ia, Ib, IIa, or IIb, for 9%, 43%, 38%, and 10%, respectively) were randomized to receive Inexium (Esomeprazole) solution for infusion (n = 375) or placebo (n = 389). After endoscopic hemostasis, patients received either 80 mg of esomeprazole as a 30-minute intravenous infusion followed by a continuous infusion of 8 mg / h for 72 hours, or a placebo. After the initial 72-hour period, all patients received Inexium (Esomeprazole) 40 mg orally open for 27 days to reduce acid secretion. The occurrence of haemorrhagic recurrence within 3 days was 5.9% in the group treated with Inexium (Esomeprazole), compared to 10.3% in the placebo group.
• During antisecretory treatment, serum gastrin concentration increases in response to reduced acid gastric secretion. CgA also increases because of the decrease in gastric acidity. Increased levels of CgA may interfere with test results for neuroendocrine tumors. Data from the literature indicate that treatment with a proton pump inhibitor should be stopped at least 5 days prior to CgA measurement. If the concentrations of CgA and gastrin have not normalized after 5 days, measurements should be repeated 14 days after discontinuation of esomeprazole.
• An increase in the number of ECL cells in relation to the increase in serum gastrin concentrations was observed in both children and adults treated with esomeprazole in the long term. The results are considered to have no clinical significance.
• During long-term treatment with anti-secretory drugs, gastric glandular cysts have been reported with a slightly increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion: they are benign and appear reversible.
• The reduction of gastric acid secretion whatever the cause, especially that induced by proton pump inhibitors (PPIs) increases in the stomach the amount of bacteria normally present in the digestive tract. PPI treatment may slightly increase the risk of gastrointestinal infections caused by germs such as Salmonella and Campylobacterand possibly due to Clostridium difficile in hospitalized patients.

Clinical efficiency

• In two studies versus ranitidine, used as an active comparator, improved efficacy with Inexium (Esomeprazole) has been demonstrated in the healing of gastric ulcers in patients treated with NSAIDs, including selective COX-2 inhibitors.
• In two placebo-controlled studies, used as a comparator, improved efficacy with Inexium (Esomeprazole) has been demonstrated in the prevention of peptic ulcers in patients treated with NSAIDs (age> 60 years and / or history of ulcer), including selective COX-2.

Pediatric population

• In a study in a pediatric population (children younger than 1 year to 17 years) with GERD receiving long-term PPI treatment, 61% of children had low levels of ECL cell hyperplasia without significance. clinically known and without development of atrophic gastritis or carcinoid tumors.

Inexium Side Effects

– This is most often:

• diarrhea
• vomiting
• abdominal pain
• rash, Quincke’s edema.

– Also reported a few cases of:

• Digestive manifestations: As with other broad-spectrum antibiotics, rare cases of enterocolitis with bloody diarrhea have been reported as well as rare cases of pseudomembranous colitis
• Hepatobiliary manifestations: moderate elevation of ASAT and ALAT transaminases
• allergic reactions: rash, itching, hives, anaphylactic shock

cutaneous manifestations: various eruptions, localized bullous eruption, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis

• headache,
• feelings of dizziness
• renal manifestations: mild increase in creatinine
•  haematological manifestations: decreased hemoglobin, thrombocytopenia, neutropenia and eosinophilia, exceptional agranulocytosis.

Inexium Interactions

Effects of esomeprazole on the pharmacokinetics of other drugs

Protease inhibitors

• Interactions between omeprazole and some protease inhibitors have been reported. The clinical significance and mechanism of these interactions are not always known. The increase in gastric pH observed with omeprazole treatment may alter the absorption of protease inhibitors. There are other mechanisms of interactions that occur via inhibition of CYP 2C19.
• For atazanavir and nelfinavir, decreased plasma concentrations have been reported when combined with omeprazole; Concomitant administration of omeprazole and these drugs is therefore not recommended. Omeprazole (40 mg once daily) administered in combination with atazanavir 300 mg with ritonavir 100 mg in healthy volunteers resulted in a substantial decrease in plasma levels of atazanavir (approximately a 75% decrease ASC, Cmax and Cmin). The increase in dosage of atazanavir to 400 mg did not offset the effect of omeprazole on the plasma concentrations of atazanavir.
• The combination of omeprazole (20 mg once daily) with atazanavir 400 mg / ritonavir 100 mg in healthy volunteers decreased the exposure to atazanavir by approximately 30% compared to the exposure observed with Atazanavir 300 mg / ritonavir 100 mg once daily administered alone.
• The association of omeprazole (40 mg once daily), decreased by 36-39% the mean AUC, C max and C _min of nelfinavir and 75-92% of the mean AUC, C _maxand C _min of its pharmacologically active metabolite M8.
• Due to the similarity of the pharmacodynamic and pharmacokinetic effects of omeprazole and esomeprazole, concomitant administration of esomeprazole and atazanavir is not recommended (see Warnings and Precautions for Use section ) .   and concomitant administration of esomeprazole and nelfinavir is contraindicated.
• For saquinavir (in combination with ritonavir), an increase in plasma concentration (80-100%) has been reported in association with omeprazole (40 mg once daily).
•  Treatment with omeprazole 20 mg once daily did not affect exposure to darunavir (ritonavir-associated) or amprenavir (ritonavir-associated).
• Treatment with esomeprazole 20 mg once daily did not affect exposure to amprenavir (with or without ritonavir).
•  Treatment with omeprazole 40 mg once daily did not affect exposure to lopinavir (ritonavir-associated).

methotrexate

• An increase in methotrexate concentrations has been observed in some patients when concomitant administration of methotrexate with proton pump inhibitors (PPIs). When administering high doses of methotrexate, temporary discontinuation of esomeprazole may be necessary.

tacrolimus

• An increase in serum tacrolimus concentrations has been observed when co-administered with esomeprazole. Enhanced monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be performed, and the dosage of tacrolimus should be adjusted if necessary.

Drugs whose absorption is pH dependent

• Inhibition of acidity e gastric during treatment with esomeprazole and other PPIs might decrease or increase the absorption of drugs if it is dependent on the gastric pH.
• As with other drugs that decrease intragastric acidity, the absorption of certain drugs, such as ketoconazole, itraconazole and erlotinib, may be decreased while the absorption of drugs such as digoxin may increase during treatment by esomeprazole.
• Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two of the ten subjects).
• The toxicity of digoxin has been reported rarely. However, special attention should be paid when esomeprazole is given in high doses in elderly patients. Therapeutic monitoring of digoxin should be strengthened.

Drugs metabolised by CYP2C19

• Esomeprazole inhibits CYP2C19, the major metabolizing enzyme of esomeprazole. Therefore, when co-administered with drugs metabolized by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin, etc., the plasma concentrations of these drugs may be increased and dose reduction may be necessary.
• This should be particularly taken into account when esomeprazole is prescribed for on-demand treatment.

diazepam

• Concomitant administration of 30 mg esomeprazole results in a 45% decrease in the clearance of diazepam metabolized by CYP2C19.

phenytoin

• Co-administration of 40 mg esomeprazole leads to a 13% increase in plasma phenytoin concentrations in epileptic patients. It is recommended to monitor the plasma concentrations of phenytoin when starting or stopping treatment with esomeprazole.

voriconazole

• Omeprazole (for the 40 mg dose once daily) resulted in increased plasma concentrations of voriconazole (a CYP2C19 substrate), with Cmax and AUC t   increased by 15 and 41% respectively.

cilostazol

• Like omeprazole, esomeprazole is an inhibitor of CYP2C19. In a crossover study, omeprazole, administered at a healthy dose of 40 mg, increased cilax and cilostazol AUC by 18% and 26%, respectively, and one of its active metabolites. 29% and 69% respectively.

cisapride

• In healthy volunteers, concomitant administration of 40 mg esomeprazole and cisapride results in a 32% increase in plasma AUC and a 31% prolongation of half-life. elimination (t1 / 2) without a significant increase in the plasma peak of cisapride.
• The slight prolongation of QTc observed after cisapride alone is not increased when concomitant administration of cisapride with esomeprazole. (see section Warnings and precautions for use ).

warfarin

• A clinical trial has shown that during the administration of 40 mg esomeprazole in patients treated with warfarin, clotting times remain within normal range. However, since marketing, a few clinically significant cases of INR elevation have been reported during concomitant treatment.
•  Monitoring is recommended at initiation and at the end of concomitant treatment of esomeprazole with warfarin or other coumarin derivatives.

clopidogrel

• The results of studies in healthy subjects showed a pharmacokinetic (PK) / pharmacodynamic (PD) interaction between clopidogrel (loading dose 300 mg / maintenance dose 75 mg daily) and esomeprazole (40 mg / day orally), resulting in approximately 40% decrease in exposure to the active metabolite of clopidogrel and approximately 14% decrease in maximal inhibition of platelet aggregation (ADP-induced).
• In a study in healthy subjects, a decrease in the exposure of approximately 40% of the active metabolite of clopidogrel was observed when taking a fixed combination of esomeprazole 20 mg and acetylsalicylic acid (ASA). mg with clopidogrel in comparison with clopidogrel alone. However, the maximum levels of inhibition of platelet aggregation (ADP-induced) in these patients were identical in the clopidogrel group and the clopidogrel + fixed combination group (esomeprazole + acetylsalicylic acid).
• Conflicting data on the clinical consequences of a PK / PD interaction of esomeprazole in terms of major cardiovascular events were observed from both observational and clinical studies. As a precaution, concomitant use of clopidogrel should be discouraged.

Drugs studied without clinically significant interaction

Amoxicillin and quinidine

• Esomeprazole has no clinically significant effect on the pharmacokinetics of amoxicillin, or quinidine.

Naproxen or rofecoxib

• Short-term studies evaluating co-administration of esomeprazole with naproxen or rofecoxib have not shown a clinically significant pharmacokinetic interaction.

Effects of other drugs on the pharmacokinetics of esomeprazole

Drugs that inhibit CYP2C19 and / or CYP3A4

• Esomeprazole is metabolized by CYP2C19 and CYP3A4.
• Co-administration of esomeprazole with a CYP3A4 inhibitor, clarithromycin (500 mg twice daily), leads to a doubling of the area under the curve (AUC) of esomeprazole.
• Concomitant administration of esomeprazole and a combination inhibitor of CYP2C19 and CYP3A4 may result in an increase of more than twice the Cmax and AUC of esomeprazole.
• Voriconazole, an inhibitor of CYP2C19 and CYP3A4, resulted in an increase in AUC t of omeprazole by 280%.
• Systematic dose adjustment of esomeprazole is not required in either of these situations.
• However, dose adjustment should be considered in patients with severe hepatic impairment, and if long-term therapy is indicated.

Drugs that induce CYP2C19 and / or CYP3A4

• Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s wort) may lead to decreased serum esomeprazole levels by increasing the metabolism of esomeprazole.

Pediatric population

• Interaction studies have only been performed in adults.

Inexium Warnings and Precautions

In the presence of any of the following alarm symptoms (such as significant and involuntary weight loss, repeated vomiting, dysphagia, hematemesis or melena) or if there is suspicion or presence of a gastric ulcer, the possibility of a malignant lesion should be excluded as Inexium (Esomeprazole) may reduce symptoms and delay the diagnosis.

Long-term use

• Patients receiving maintenance treatment (and, more specifically, those treated for more than one year) should be followed regularly.

On demand processing

• Patients with on-demand treatment should be advised of the need to contact their doctor if their symptoms change.

Eradication of Helicobacter pylori

• In the case of prescription of lesomeprazole for eradication of Helicobacter pylori , the possible drug interactions of all components of the treatment should be taken into consideration.
• Clarithromycin is a potent inhibitor of CYP3A4 and therefore contraindications and clarithromycin interactions should be considered when treatment with concomitant use of drugs that are metabolised by CYP3A4, such as cisapride.

Gastrointestinal infections

• IPP treatment may slightly increase the risk of gastrointestinal infections caused by germs such as Salmonellaand Campylobacter .

Absorption of vitamin B12

• Like all drugs aimed at decreasing the secretion of gastric acids, lesomeprazole can decrease the absorption of vitamin B12 (cyanocobalamin) due to hypohydrochloride or lachlorhydria. This should be taken into account during long-term treatment in patients with a reduced vitamin B12 reserve or risk factors leading to decreased absorption of vitamin B12.

hypomagnesemia

• Severe hypomagnesemic cases have been reported in patients treated with proton pump inhibitors (PPIs) such as esomeprazole for at least three months, and in most cases for one year. Hypomagnesemia can manifest itself in serious clinical signs such as fatigue, tetany, delirious flushes, convulsions, dizziness, ventricular arrhythmia, but it can start insidiously and go unnoticed. In most patients, hypomagnesemia improved after magnesium supplementation and discontinuation of PPI.
• In patients requiring prolonged therapy or when PPIs are combined with digoxin or with drugs that may induce hypomagnesaemia (eg diuretics), blood magnesium levels should be considered by health professionals before starting treatment with IPP and regularly during treatment.

Risk of fractures

• Proton pump inhibitors, particularly if they are used in high doses over a prolonged period (> 1 year), may moderately increase the risk of hip, wrist and vertebral fractures, mainly in elderly or elderly patients.
• in the presence of other identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10-40%. This increase may be due in part to other risk factors.
• Patients at risk of osteoporosis should be managed according to the recommendations in force and receive appropriate vitamin D and calcium intake.

Subacute cutaneous lupus erythematosus (LECS)

• Inhibitors of the proton pump are associated with very occasional cases of LECS. If lesions develop, especially on the skin areas exposed to the sun, and if they are accompanied by arthralgia, the patient must consult a doctor quickly and the health professional must consider stopping Inexium (Esomeprazole).
• The occurrence of LECS after treatment with a proton pump inhibitor may increase the risk of LECS with other proton pump inhibitors.

Association with other medicines

• The combination of lesomeprazole with latazanavir is not recommended (see section 4.5). If the combination of latazanavir with a proton pump inhibitor is considered essential, close clinical monitoring is recommended, together with an increase in the dose of 400 mg datazanavir with 100 mg ritonavir; a maximum dose of 20 mg deomeprazole should not be exceeded.
• Lesomeprazole is an inhibitor of CYP2C19. At the beginning or end of treatment with omeprazole, the risk of interactions with drugs metabolized by CYP2C19 should be considered. An interaction between clopidogrel and lesomeprazole has been observed (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, the concomitant use of deomeprazole and clopidogrel should be discouraged.
• If deomeprazole treatment is prescribed on demand, the impact on interactions with other drugs should be taken into account due to fluctuations in plasma concentrations of lesomeprazole.

Sucrose

• This medicine contains sucrose. This medicine is contraindicated in patients with fructose intolerance, glucose or galactose malabsorption syndrome or sucrase-isomaltase deficiency.

Drive and use machines

• Esomeprazole has a minor influence on the ability to drive and use machines. Side effects such as dizziness (uncommon) and blurred vision (rare) have been reported .
• Affected patients should not drive or use machinery.

PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

• Due to the expected benefit, the use of cefpodoxime may be considered during pregnancy if needed, despite insufficient clinical and animal data.

Breast-feeding

• The passage into breast milk is low and the amounts ingested are well below therapeutic doses. As a result, breastfeeding is possible when taking this antibiotic.
• However, discontinue breastfeeding (or medication) if diarrhea, candidiasis or rash occurs in infants.

What should I do if I miss a dose?

• Take it as soon as possible. However, if you are near the time of taking the next dose, do not take the dose you have forgotten, but continue your treatment normally.
• Do not take a double dose to make up for the dose you forgot to take.

What is  Forms and Composition?

• 20 mg gastro-resistant film-coated tablet (oblong, biconvex, engraved “20 mg” on one side and “A / EH” on the other side, light pink):   Boxes of 7, 14 and 28, under platelets.
• Hospital model: Box of 50, under pads. 40 mg gastroresistant film-coated tablet (oblong, biconvex, engraved “40 mg” on one side and “A / EI” on the other side, pink):   Boxes of 14 and 28, under blisters. Hospital model: Box of 50, under pads.

• Excipients (common): glycerol monostearate (40-55), hydroxypropylcellulose, hypromellose, red-brown iron oxide E 172, yellow iron oxide E 172 (cp at 20 mg only), magnesium stearate, methacrylic acid copolymer and ethyl acrylate (1: 1) 30% dispersion, microcrystalline cellulose, synthetic paraffin, macrogol 6000, polysorbate 80, crospovidone, sodium stearyl fumarate, neutral microgranules (sucrose and corn starch), talc, titanium E 171, triethyl citrate.
• Excipient (s) with known effect: sucrose (28 mg / day to 20 mg, 30 mg / day to 40 mg).

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.

Ogast Generic drug of the Therapeutic class: Gastro-Entero–Hepatology
active ingredients: Lansoprazole

Important to know about Ogast ?

Your doctor may prescribe Ogast for the following indications:

• Treatment of duodenal ulcer and gastric ulcer.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of reflux oesophagitis.
• Treatment of heartburn and acid regurgitation.
• Treatment of infections caused by Helicobacter pylori bacteria when prescribed in combination with antibiotic therapy
• Treatment or prevention of duodenal ulcer or gastric ulcer in patients requiring continuous NSAID treatment (NSAID therapy is prescribed for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Ogast for a different indication or at a different dose than indicated in this leaflet. Follow your doctor’s instructions for taking your medicine.

WHAT IS Ogast Indications?

Ogast Dosage

• Swallow the capsule with a glass of water. If you find that the capsules are hard to swallow, your doctor may advise you on other ways to take the medicine. Do not crush or crush the capsules or their contents as this will alter their properties.
  • If you take OGAST once a day, try taking it at the same time each day. You can get better results if you take OGAST as soon as you get up in the morning.
  • If you take OGAST twice a day, take the first dose in the morning and the second dose in the evening.
• The dosage of OGAST depends on your condition. The usual OGAST dosages for adults are shown below. Your doctor may sometimes prescribe a different dosage and will tell you the duration of the treatment.
  • Treatment of heartburn and acid regurgitation: one capsule of 15 mg or 30 mg daily for 4 weeks. If symptoms persist, talk to your doctor. If your symptoms are not alleviated within 4 weeks, contact your doctor.
  • Treatment of duodenal ulcer: one 30 mg capsule each day for 2 weeks.
  • Treatment of gastric ulcer: one 30 mg capsule each day for 4 weeks.
  • Treatment of inflammation of the esophagus (reflux esophagitis): one 30 mg capsule each day for 4 weeks.
  • Long-term prevention of reflux esophagitis: one 15 mg capsule daily; Your doctor may adjust the dosage to one 30 mg capsule daily.
  • Treatment of Helicobacter pylori infection : The usual dosage is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. The treatment is to be taken every day generally for 7 days.

The recommended antibiotic combinations are:

• OGAST 30 mg with clarithromycin 250-500 mg and amoxicillin 1000 mg.
• OGAST 30 mg with clarithromycin 250 mg and metronidazole 400-500 mg.

If you are being treated for an ulcer infection, it is unlikely that it will reappear if the infection is treated successfully. For your medicine to work as well as possible, stick to the set times and do not miss a shot.

Treatment of duodenal ulcer or gastric ulcer in patients requiring treatment with NSAIDs (non-steroidal anti-inflammatory drugs) continuously: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal ulcer or gastric ulcer in patients requiring NSAID treatment (non-steroidal anti-inflammatory drugs) continuously: one 15 mg capsule daily; Your doctor may adjust the dosage to one 30 mg capsule daily.

Zollinger-Ellison Syndrome: The recommended starting dose is two 30 mg capsules per day to begin with, and depending on your response to OGAST, your doctor may decide to adjust the dose.

USE IN CHILDREN:

1. OGAST should not be given in children.
2. Always take the dose recommended by your doctor. If uncertain, consult your doctor.

Ogast Contraindications

How it works Ogast?

Pharmacotherapeutic group: INHIBITORS OF THE PROTON PUMP ,

ATC Code: A02BC03 .

• Lansoprazole is an inhibitor of the gastric proton pump.
• It makes it possible to inhibit the last stage of formation of gastric acid by inhibiting the activity of the H ⁺ / K ⁺ ATPase proton pump at the parietal cells of the stomach. Inhibition is reversible and dose-dependent. Its effects are exerted at the same time on the secretions of basal and stimulated gastric acid.
• Lansoprazole concentrates in parietal cells and becomes active in their acid environment and reacts with the sulfohydric group of the H ⁺ / K ⁺ ATPase proton pump resulting in inhibition of enzyme activity.

Effect on gastric acid secretion :

• Lansoprazole is a specific proton pump inhibitor of parietal cells. A single oral dose of lansoprazole inhibits pentagastrin-stimulated gastric acid secretion by approximately 80%. After repeated daily administration for a period of seven days, approximately 90% of the gastric secretion is inhibited.
• It has a similar effect on basal gastric acid secretion. Single oral administration of 30 mg reduces basal secretion by approximately 70%; patients’ symptoms are thus improved at the first dose.
• After 8 days of repeated administration, the reduction is approximately 85%. Rapid symptomatic relief is achieved with one capsule (30 mg) daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer or reflux esophagitis within 4 weeks.
• By reducing gastric acidity, lansoprazole creates an environment in which the appropriate antibiotics can be effective againstH. pylori .

Ogast Side Effects

Common side effects (may affect up to 1 in 10 people):

1. · Headache, dizziness,
2. · Diarrhea, constipation, stomach pain, nausea, vomiting, flatulence, dryness or mouth / throat pain,
3. · Extensive skin rash, itching,
4. · Disruption of liver function (liver),
5. · Fatigue,
6. · Benign polyps of the stomach.

Uncommon side effects (may affect up to 1 in 100 people):

1. · Depression,
2. · Muscle or joint pain,
3. · Fluid retention or dime,
4. · Changes in the blood count

Rare side effects (may affect up to 1 in 1000 people):

1. · Fever,
2. · Agitation, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo,
3. · Taste alteration, loss of appetite, inflammation of the tongue (glossitis),
4. · Skin reactions, such as burning or tingling, hematoma, redness and sweating,
5. · Photosensitivity,
6. · Hair loss,
7. · Tingling (paresthesia), tremors,
8. · Anemia (pallor),
9. · Kidney problems,
10. · Pancreatitis,
11. · Hepatitis (which may be manifested by a yellowing of the skin or eyes),
12. · Swelling of breasts in men, impotence,
13. · Candidiasis (infection of the skin or mucous membranes due to fungi),
14. · Angioedema; contact your doctor immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty swallowing, hives, or difficulty breathing.

Very rare side effects (may affect up to 1 in 10,000 people):

1. · Severe hypersensitivity including shock. Symptoms of hypersensitivity may include fever, extensive rash, dementia, and sometimes a drop in blood pressure.
2. · Inflammation of the mouth (stomatitis),
3. · Colitis (intestinal inflammation),
4. · Changes in the levels of sodium, cholesterol and triglycerides in the blood,
5. · Very severe skin reactions with redness, bullous appearance, severe inflammation and desquamation,
6. · Very rarely OGAST can cause a decrease in the number of white blood cells that can alter the resistance to infections. If an infection appears with symptoms such as fever and severe deterioration of your condition, or fever with symptoms of local infection, such as sore throat / pharynx / mouth or urinary problems, consult your doctor immediately. A blood test will be performed to monitor a possible decrease in white blood cells (agranulocytosis).

Frequency unknown

· If you take OGAST for more than 3 months, it is possible that the level of magnesium in your blood will decrease. Low levels of magnesium can lead to fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. If you experience any of these symptoms, please inform your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may decide to have regular blood tests to monitor your magnesium levels.

· Rash, possibly with joint pain.

Ogast Interactions

Effects of lansoprazole on other medicines

Drugs with pH-dependent absorption

Lansoprazole may interfere with the absorption of other drugs, for which gastric pH is a determining factor in their oral bioavailability.

HIV Protease Inhibitors:

• Concomitant administration of lansoprazole and HIV protease inhibitors, for which absorption is pH-dependent (atazanavir, nelfinavir), is not recommended as this may significantly reduce their bioavailability (see section 5.2). caution and precautions for use ).

Ketoconazole and itraconazole:

• The absorption of ketoconazole and itraconazole in the gastrointestinal tract is increased in the presence of gastric acid. Administration of lansoprazole may induce concentrations below the therapeutic threshold of ketoconazole and itraconazole and the combination should be avoided.

Digoxin:

• The combination of lansoprazole and digoxin may result in increased plasma concentration of digoxin. Plasma digoxin concentrations should therefore be monitored and the dose of digoxin adjusted if necessary at the beginning and end of lansoprazole treatment.

methotrexate

• Concomitant use of high doses of methotrexate may increase and prolong blood levels of methotrexate and / or its metabolites that may lead to methotrexate toxicity. Therefore, in situations where high doses of methotrexate are used, temporary discontinuation of lansoprazole should be considered.

warfarin

• The combination of 60 mg lansoprazole and warfarin did not affect the pharmacokinetics of warfarin or INR. However, some cases of increased INR and prothrombin time have been reported with concomitant administration of warfarin and PPI. An increase in INR and prothrombin time can cause bleeding, potentially fatal. Therefore, in patients treated concurrently with lansoprazole and warfarin, monitoring of INR and prothrombin time is recommended, particularly at the start and end of concomitant therapy.

Drugs metabolized by cytochrome P450 enzymes

• Lansoprazole may increase the plasma concentrations of drugs metabolized by CYP3A4. Caution is advised when lansoprazole is combined with drugs that are metabolized by this enzyme and have a low therapeutic margin.

Theophylline:

• Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect. The patient should be monitored with concomitant administration of lansoprazole and theophylline.

Tacrolimus:

• Concomitant administration of lansoprazole increases plasma concentrations of tacrolimus (a substrate of CYP3A and P-gp). Taking lansoprazole increases the average rate of tacrolimus up to 81%. Monitoring plasma concentrations of tacrolimus is recommended at the beginning or end of lansoprazole therapy.

Drug transported by P-glycoprotein

• Inhibition of P-glycoprotein (P-gp) by lansoprazole was observed in vitro . Clinical relevance is unknown.
• Effects of other drugs on lansoprazole

Drugs inhibiting CYP2C19

Fluvoxamine:

• A dose reduction may be considered when lansoprazole is combined with fluvoxamine, a CYP2C19 inhibitor. Plasma concentrations of lansoprazole are increased up to 4 times normal.

Drugs inducing CYP2C19 and CYP3A4

• Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St. John’s wort ( Hypericum perforatum) can significantly reduce plasma concentrations of lansoprazole.

Other

1. Sucralfate / Anti-acids:
2. Sucralfate and antacids may decrease the bioavailability of lansoprazole. Therefore, lansoprazole should be taken at least 1 hour after taking these medications.
3. No clinically significant interactions between lansoprazole and nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interaction studies have been performed.

Warnings and Precautions

• As with all other anti-ulcer treatments, the possibility of malignant gastric tumor should be ruled out when treating gastric ulcer with lansoprazole because it may mask the symptoms and delay the diagnosis.
• Cases of severe hypomagnesemia have been reported in patients treated with proton pump inhibitors (PPIs) such as lansoprazole for at least three months and in most cases for one year. Hypomagnesaemia may be manifested by severe clinical signs such as fatigue, tetany, delirious flushes, convulsions, dizziness, ventricular arrhythmia, but it may start insidiously and go unnoticed.In most patients, hypomagnesemia is improved after magnesium supplementation and stopping the PPI.
• In patients requiring prolonged treatment or in combination of PPIs with digoxin or with drugs that may induce hypomagnesaemia (eg diuretics), blood magnesium levels should be considered by health professionals before start treatment with IPP and then regularly during treatment.
• Lansoprazole should be used with caution in patients with severe or moderate hepatic impairment (see sections Dosage and Administration and Pharmacokinetics ).
• A decrease in gastric acidity due to lansoprazole may increase the levels of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slight increase in the risk of gastrointestinal infections, particularly due to Salmonella and Campylobacter.
• In patients with peptic ulcer disease, the possibility of H. pylori infection as an etiological factor should be considered.
• If lansoprazole is used in combination with antibiotics for the treatment of eradication of H. pylori , then the conditions of use of these antibiotics should also be followed.
• Due to limited safety data for patients on maintenance treatment for more than one year, regular monitoring of the treatment and a thorough benefit-risk assessment should be performed regularly in these patients.
• Very rare cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and / or persistent diarrhea, discontinuation of treatment should be considered.
• Treatment for the prevention of peptic ulceration in patients requiring continuous NSAID treatment should be limited to high-risk patients (eg, history of gastrointestinal bleeding, perforation or ulcer, advanced age, drug combination known to increase probability occurrence of adverse events of the upper gastrointestinal tract [example: corticosteroids or anticoagulants], presence of a serious factor of co-morbidity or prolonged use of NSAIDs at the maximum recommended doses).
• Proton pump inhibitors, particularly if used in high doses over a prolonged period (> 1 year), may moderately increase the risk of fracture of the hip, wrist and vertebrae, mainly in patients aged or in the presence of other identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10-40%. This increase may be due in part to other risk factors. Patients at risk for osteoporosis should be managed according to the recommendations in force, and receive appropriate vitamin D and calcium intake.
• Due to the presence of sucrose, this drug is contraindicated in cases of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare hereditary metabolic diseases).

Drive and use machines

Adverse reactions such as dizziness, vertigo, visual disturbances and drowsiness may occur. Under these conditions, the ability to react can be decreased.

PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

1. There are no data on the use of lansoprazole in pregnant women. Studies in animals have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, childbirth or postnatal development.
2. Therefore, the use of lansoprazole is not recommended during pregnancy.

feeding

1. It is not known if lansoprazole is excreted in breast milk. Studies in animals have shown the excretion of lansoprazole in milk.
2. A decision should be made either to continue / interrupt breastfeeding or to continue / discontinue lansoprazole treatment, taking into account the benefit of breastfeeding for the benefit of treatment for the woman.

Fertility

1. No data on the effect of lansoprazole on human fertility is available. Lansoprazole did not affect fertility in male and female rats.

What should I do if I miss a dose?

• If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. If this is the case, do not take the missed dose, and normally take the other capsules. Do not take a double dose to make up for the dose you forgot to take.

What happens if I overdose from Ogast ?

The effects of lansoprazole overdosage in humans are not known (although the acute toxicity is likely to be low), and therefore no treatment behavior can be specified. However, daily doses up to 180 mg lansoprazole orally and up to 90 mg lansoprazole intravenously have been administered in clinical trials without significant adverse effects.

Please refer to the section Adverse Reactions for possible symptoms of lansoprazole overdosage.

In the case of a suspected overdose, the patient should be monitored. Lansoprazole is not significantly removed by hemodialysis. If necessary, gastric lavage, charcoal use and symptomatic treatment are recommended.

What is  Forms and Composition?

• Each capsule contains 30 mg lansoprazole.
• Excipients with known effect: Each capsule contains 59.8 mg of sucrose.
• For the full list of excipients, see section 6.1.

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.

motilium tablet >> Generic drug of the Therapeutic class: Gastro-Entero – Hepatology
active ingredients: Domperidone

what is motilium?

• Domperidone stimulates the movement of the stomach and intestines. It ensures that food goes faster from the stomach to the intestine. It helps migraines to make painkillers work faster. With breastfeeding, domperidone causes you to make more breast milk.
• In case of nausea and vomiting, upset stomach, migraine and problems with breastfeeding. Sometimes also with certain forms of low blood pressure .
• Tablets and drink: works within 15 to 30 minutes. The effect lasts 6 to 8 hours. Use this medicine 15 to 30 minutes before a meal.

• Shake the drink well before measuring the dose .
• Migraine attack: use domperidone at the same time as the painkiller .
• Use domperidone as short as possible, no longer than 1 week. If you use it longer, you are more likely to have cardiac arrhythmia.
• You may experience a dry mouth. This may result in earlier holes in your teeth. Brush and floss than extra good.

what is motilium used for and indication?

Motilium (Domperidone) is indicated for the relief of symptoms such as nausea and vomiting.

Motilium Dosage

• Motilium (Domperidone) should be used at the lowest effective dose for the shortest time needed to control nausea and vomiting.
• It is recommended to take Motilium (Domperidone) before meals. If the medicine is taken after meals, its absorption is somewhat delayed.
• Patients should strive to take each dose on time. If a scheduled dose is missed, this dose should not be taken and the usual regimen should be continued. The dose should not be doubled to compensate for an omitted dose.
• Usually, the maximum duration of treatment should not exceed one week.

Adults and adolescents (from 12 years and 35 kg)

• One 10 mg tablet, up to 3 times daily, the maximum dose being 30 mg per day.

Newborns, infants, children (under 12 years) and adolescents under 35 kg

• Given the need for an exact dosage, the tablet form is not suitable for children and adolescents weighing less than 35 kg. In these patients, it is recommended to use the oral suspension form.

Hepatic insufficiency

• Motilium (Domperidone) is contraindicated in patients with moderate or severe hepatic impairment.
• A change in dose is not necessary, however, in patients with mild hepatic impairment.

Renal failure

• Since the elimination half-life of domperidone is prolonged in cases of severe renal insufficiency, in cases of repeated administration, the frequency of administration of Motilium (Domperidone) should be reduced to one or two doses per day depending on degree of severity of renal failure. A dose reduction may be necessary.

Contraindications

CONTRA-INDICATE:

• Motilium is against-indicated in the following cases:
  •  Known hypersensitivity to domperidone or to any of the excipients of MOTILIUM.
  • Prolactin-bearing pituitary tumor (prolactinoma).
•  MOTILIUM should not be used when stimulation of gastric motricity can be harmful:
  • gastrointestinal bleeding, mechanical obstruction or perforation.
•  The effervescent granules contain sucrose and may be unsuitable in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
• Use in patients at risk of phenylketonuria: the effervescent granules contain aspartame. Do not use it in patients at risk of phenylketonuria.
•  Use in hepatic disorders: domperidone is highly metabolized in the liver, MOTILIUM must not be used in patients with hepatic disorders.
•  Use during breast-feeding: the total quantity of domperidone excreted in breast milk is estimated to be less than 7 μg per day at the maximum recommended dosage. The toxicity to newborns is unknown. Therefore, MOTILIUM should not be used during breast-feeding.

NOT RECOMMENDED :

Pregnancy:

• There are few post-marketing data from the use of domperidone in pregnant women.
•  A study in rats showed a toxic effect on reproduction at high dose, toxic to the mother.
• The possible risk in humans is unknown. Therefore,
• MOTILIUM should only be used during pregnancy when the expected therapeutic benefit justifies it.

how motilium works?

• Domperidone is a dopamine antagonist with antiemetic properties that does not readily cross theblood-brain barrier. In domperidone users , particularly in adults, extrapyramidal disorders are very rare, but domperidone causes release of prolactin from the pituitary gland.
• Its antiemetic effect appears to be due to a combination of peripheral effects (gastric motility) and antagonism of dopaminergic receptors in the chemoreceptor stimulation zone, located outside the blood-brain barrier , in the area postrema.
• Studies in animals, as well as low concentrations found in the brain, indicate a predominant peripheral effect of domperidone on dopamine receptors.
• Studies in humans have shown that per os domperidone increases the tone of the lower esophageal sphincter, improves antroduodenal motility and accelerates gastric emptying. There is no effect on gastric secretion.
• In accordance with ICH-E14, a thorough study of the QT interval has been performed.
• This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects at a dose of 10 or 20 mg domperidone administered 4 times daily up to a maximum daily dose of 80 mg.
• This study demonstrated a maximum difference in the QTc interval between domperidone and placebo (using the least squares method for variation from baseline) of 3.4 ms with 20 mg of domperidone administered 4 times per day on Day 4. Bilateral 90% CI (1.0 to 5.9 ms) did not exceed 10 ms.
• No clinically relevant effect on QTc interval was observed in this study when domperidone was administered until
• However, two previous studies of drug interactions have shown some QTc prolongation when domperidone is administered as monotherapy (10 mg 4 times daily).
• The largest mean difference in time-adjusted QTcF interval between domperidone and placebo was 5.4 ms (95% CI -1.7 to 12.4) and 7, respectively. 5 ms (95% CI: 0.6 to 14.4).

What are the side effects of motilium?

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

The main side effects are the following.

Rarely (from 1 to 10 in 100 people)

• Transient intestinal cramps , these usually disappear after some time. These cramps are the result of the stimulating effect of domperidone on the intestines.
• Dry mouth. As a result, holes in your teeth may develop earlier. Therefore, polish and floss extra well if you notice that you suffer from a dry mouth. Have the dentist check your teeth more often if you use this medicine for several weeks.

Very rare (affects less than 1 in 100 people)

• Breast formation in men and swelling of mammary glands in women. Milk can also flow from the breasts and the menstruation can become disrupted. These symptoms disappear within a few days after stopping domperidone.
• Hypersensitivity to this agent. You will notice this by skin rashes and hives. Do not use this medicine any more. Severe hypersensitivity can be seen from chest tightnessor a swollen face. Then go immediately to a doctor. In both cases you should not use this medicine in the future. Therefore, tell the pharmacy that you are hypersensitive to domperidone. The pharmacy team can then ensure that you do not get the product again.
• Movement disorders , these are also called extrapyramidal phenomena. They are disorders in the control of the muscles. Symptoms may resemble the symptoms of Parkinson’s disease: stiff muscles, tremors, difficulty walking or talking, restlessness, sudden muscle twitches. If you notice this warning to your doctor.
• An increased risk of cardiac arrhythmia . You may suffer from sudden dizziness or briefly become unconscious. This is especially important for people with a certain heart rhythm disorder , namely the congenital prolonged QT interval . Do NOT use this medicine if you have this cardiac arrhythmia . Consult with your doctor. You may be able to switch to another means.
• Domperidone is removed from the body through the liver. If you have a reduced liver function , you should therefore not use this medication. Consult with your doctor about this.
• Diarrhea. Have you been using this medicine for several weeks and you still suffer from diarrhea after a few weeks? Consult your doctor.
• Headache , dizziness, general feeling of weakness, anxiety and sleepiness. Will you continue to suffer from it after a few days? Then contact your doctor.
• Less sense in lovemaking. If you have problems with this, talk to your doctor.

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.

motilium drug interactions

If antacid or antisecretory drugs are also prescribed, they should not be taken at the same time as Motilium (Domperidone) (domperidone base). Thus, they will have to be taken after the meal and not before.

Association with levodopa

• Although a dose adjustment of levodopa is not considered necessary, an increase in plasma concentration (30-40% maximum) has been observed when domperidone is taken concomitantly with levodopa.
• The main metabolic pathway of domperidone involves CYP3A4. In vitro data suggest that concomitant administration of drugs that significantly inhibit CYP3A4 may result in increased plasma concentrations of domperidone.
• Increased risk of QT prolongation due to pharmacodynamic and / or pharmacokinetic interactions.

Associations contraindicated

Drugs that prolong the QTc interval (risk of torsades de pointes)

•  Class IA antiarrhythmics (eg, disopyramide, hydroquinidine, quinidine)
•  Class III antiarrhythmic drugs (eg amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
•  Certain antipsychotics (eg haloperidol, pimozide, sertindole)
•  Certain antidepressants (eg citalopram, escitalopram)
•  Certain antibiotics (eg erythromycin, levofloxacin, moxifloxacin, spiramycin)
•  Some antifungals (eg fluconazole, pentamidine)
•  Some antimalarial drugs (especially halofantrine, lumefantrine)
•  Some digestive drugs (eg cisapride, dolasetron, prucalopride)
•  Some antihistamines (eg mequitazine, mizolastine)
•  Certain anticancer drugs (eg toremifene, vandetanib, vincamine)
•  Some other drugs (eg, bepridil, diphémanil, methadone)

(see Contraindications section ).

Strong inhibitors of CYP3A4 (regardless of their QT prolongation effects), ie:

•  Anti-proteases (eg ritonavir, saquinavir and telaprevir)
• Systemic azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole)
• Some macrolide antibiotics (eg, clarithromycin and telithromycin)

(see Contraindications section ).

Associations advised against

• Moderate inhibitors of CYP3A4 , ie diltiazem , verapamil and some macrolides.

Associations subject to precautions for use

• Caution should be exercised with drugs that induce bradycardia and hypokalemia, and with the following macrolides that prolong the QT interval: azithromycin and roxithromycin (clarithromycin is contraindicated because it is a potent inhibitor of CYP3A4).
• The list of substances mentioned above is representative and not exhaustive.

Warnings and Precautions

motilium warning

Renal failure

The elimination half-life of domperidone is prolonged in severe renal impairment. Therefore, in case of repeated administrations, the frequency of administration of domperidone should be reduced to one or two doses per day depending on the degree of severity of the renal failure. A dose reduction may be necessary.

Cardiovascular effects

• Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. In post-marketing surveillance, very rare cases of QT prolongation and torsades de pointes have been reported in patients treated with domperidone. These cases involve patients with risk factors, electrolyte abnormalities and associated treatments that may have been contributing factors.
• Epidemiological studies have shown that domperidone is associated with an increased risk of serious ventricular arrhythmias or sudden death (see section 4.8 ). A higher risk was observed in patients over 60 years of age, patients treated with daily doses greater than 30 mg and patients treated concurrently with drugs that prolong the QT interval or CYP3A4 inhibitors.
• Domperidone should be used at the lowest effective dose in adults and children.
• Domperidone is contraindicated in patients with known prolongation of cardiac conduction intervals, including QTc interval, patients with significant electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia, or patients with underlying cardiac conditions such as congestive heart failure due to the increased risk of ventricular arrhythmias. Electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesaemia) and bradycardia are known to increase proarrhythmic risk.
• Domperidone treatment should be discontinued if signs or symptoms that may be associated with cardiac arrhythmia occur and patients should consult their physician.
• Patients should be asked to report any heart symptoms immediately.

Pediatric population

• Although neurological side effects are rare (see section  4.8 ), the risk of neurological side effects is higher in young children, as their metabolic functions and blood-brain barrier are not fully developed during the first few years. month of life. It is therefore recommended that the dose be precisely determined and strictly followed in the newborn, infant and child (see section  Dosage and method of administration ).
• Overdose may cause extrapyramidal disorders in children, but other etiologies should also be considered.

Precautions for use

• The film-coated tablets contain lactose and may be unsuitable in patients with lactose intolerance, galactosemia or glucose or galactose malabsorption.

Drive and use machines

• Drowsiness and dizziness have been observed following the use of domperidone.
• As a result, patients should be informed that they should not drive or use machinery, or engage in other activities requiring vigilance and coordination, until they know what effect Motilium (Domperidone) is having on them.

Pregnancy / Breastfeeding

motilium during pregnancy

• There is little postmarketing data on the use of domperidone in pregnant women. A study in rats showed a toxic effect on reproduction in case of high dose, toxic for the mother. The potential risk in humans is unknown.
• Therefore, Motilium (Domperidone) should be used during pregnancy only when the expected therapeutic benefit justifies it.

feeding

• Domperidone is excreted in human breast milk and breastfed children receive less than 0.1% of the weight adjusted maternal dose. The occurrence of adverse effects, particularly cardiac effects, can not be ruled out after exposure via breast milk.
• A decision should be made to stop breastfeeding or to discontinue / abstain from domperidone treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
• Caution should be exercised when risk factors for QTc prolongation are present in breastfed infants.

What happens if I overdose from Motilium ?

sYMPTOMS

• Cases of overdose have been reported mainly in infants and children. Symptoms of overdose may include agitation, disturbances of consciousness, convulsions, disorientation, somnolence, and extrapyramidal reactions.

Treatment

• There is no specific antidote for domperidone. In case of overdose, standard symptomatic treatment should be given immediately. ECG monitoring is recommended because of the possibility of QT prolongation.
• Gastric lavage and administration of activated charcoal may be helpful. Close medical supervision and symptomatic treatment are recommended.
• Anticholinergic or antiparkinson drugs may be useful in controlling extrapyramidal disorders.

What is  Composition ?

• Core: Lactose, Corn starch, Microcrystalline cellulose (E460), Potato starch, Povidone (E1201), Magnesium stearate (E572), Cottonseed oil, Sodium lauryl sulfate (E487), Film coating: Sodium lauryl sulfate (E487), Hypromellose (E464)
• Core: Lactose, Corn starch, Microcrystalline cellulose (E460), Potato starch, Povidone (E1201), Magnesium stearate (E572), Cottonseed oil, Sodium lauryl sulfate (E487), Film coating: Sodium lauryl sulfate (E47), Hypromellose (E464)

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.