Generic

Esomeprazole Magnesium Trihydrate

Indications

• Gastro-esophageal Reflux Disease (GERD) is treated with esomeprazole MUPS tablets (GERD).
• NSAID-related stomach ulcer risk is reduced.
• Eradication of Helicobacter pylori (Triple therapy).
• Idiopathic hypersecretion and Zollinger-Ellison syndrome

Pharmacology

Esomeprazole is a proton pump inhibitor that inhibits the H+/K+ ATPase in the gastric parietal cell, suppressing gastric acid output. The first single optical isomer of a proton pump inhibitor, esomeprazole (S-isomer of omeprazole), provides superior acid control than racemic proton pump inhibitors.

Dosage 

Erosive esophagitis-

• Adult (≥18 years): 40 mg once daily for 4 weeks.
• Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.

Maintenance of healing of erosive esophagitis-

• Adult (≥18 years): 20 mg once daily.
• Children & adolescents (12-18 years): 20 mg once daily.

Risk reduction in NSAID associated gastric ulcer-

• Adult (≥18 years): 20 mg once daily for 4-8 weeks.

H. pylori eradication (Esomeprazole MUPS tablet with 1000 mg Amoxicillin and 500 mg Clarithromycin)-

• Adult (≥18 years): 20 mg twice daily for 7 days.
• Children & adolescents (12-18 years): 20 mg twice daily for 7 days.

Zollinger-Ellison syndrome and idiopathic hypersecretion-

• Adult (≥18 years): 40-80 mg twice daily.

Children 1-11 years:

• Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
• Maintenance of healing of erosive esophagitis: 10 mg once daily

Children below the age of 1 year: Esomeprazole MUPS tablet is not approved for use in children younger than 1 year.

Administration

Interaction

Esomeprazole is broadly metabolized within the liver by CYP2C19 and CYP3A4. In vitro and in vivo thinks about have shown that Esomeprazole isn't likely to restrain CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically significant intuitive with drugs metabolized by these CYP proteins would be anticipated. Medicate interaction thinks about have appeared that Esomeprazole does not have any clinically noteworthy intuitive with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. Esomeprazole may possibly meddled with CYP2C19, the major Esomeprazole metabolizing chemical. Co-administration of Esomeprazole 30 mg anddiazepam, a CYP2C19 substrate has brought about in a 45% diminish in clearance of diazepam. Expanded plasma levels of diazepam have been watched 12 hours after dosing and onwards. Esomeprazole hinders gastric corrosive discharge. Hence, Esomeprazole may meddled with the retention of drugs where gastric pH is an imperative determinant of bioavailability (e.g., ketoconazole, press salts a

Co-administration of verbal contraceptives, diazepam, phenytoin, or quinidine don't appear to alter the pharmacokinetic profile of Esomeprazole. Combination Treatment with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increments within the plasma levels of esomeprazole and 14-hydroxyclarithromycin.

Contraindications

In patients who have a history of hypersensitivity to any of the formulations, esomeprazole is not recommended.

Side Effects

Headache, diarrhoea, nausea, flatulence, abdominal pain, constipation, and dry mouth are the most common side effects reported with Esomeprazole. When compared to short-term treatment, there is no difference in the categories of linked adverse events noticed with maintenance treatment up to 12 months.

Pregnancy & Lactation

Caution is advised by the manufacturer. Esomeprazole or its metabolites are not known to occur in human breast milk.

Precautions & Warnings

If the patient has severe liver failure and renal impairment, esomeprazole should be administered with caution. Proton pump inhibitors, such as Esomeprazole, may marginally increase the risk of hip, wrist, and spine fractures, especially when used for more than a year.

Therapeutic Class

Inhibitor of the proton pump.

Storage Conditions

Protect from light and store in a cool, dry area below 25°C. Keep out of children's reach.

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.