Esomium20

Composition

Esomium 20 capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP 22.27 mg equivalent to Esomeprazole 20 mg in enteric coated pellets.

Esomium 40 capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP 44.54 mg equivalent to Esomeprazole 40 mg in enteric coated pellets.

Description Esomeprazole is a proton pump inhibitor that suppresses gastric acid

+ + secretion by specific inhibition of the H /K -ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole reduces gastric acidity by blocking the final step in acid production.

Indication

  • Treatment of Gastroesophageal Reflux Disease (GERD)
  • Healing of erosive esophagitis
  • Maintenance of healing of erosive esophagitis
  • Symptomatic relief of Gastroesophageal Reflux Disease (GERD)
  • Risk reduction of NSAID associated gastric ulcer
  • H. pylori eradication (Triple therapy)
  • Zollinger-Ellison Syndrome

Dosage and Administration

Gastroesophageal Reflux Diseases (GERD)

Healing of erosive esophagitis

20 mg or 40 mg

Once daily for 4 to 8 weeks

Maintenance of healing of erosive esophagitis

20 mg

Once daily

Symptomatic relief of Gastroesophageal Reflux Disease (GERD)

20 mg

Once daily for 4 weeks

Risk reduction of NSAID associated gastric ulcers

20 mg

Once daily for upto 6 months

  1. eradication (Triple therapy)

 

Esomeprazole

20 mg

Twice daily for 10 days

Amoxicillin

1000 mg

Twice daily for 10 days

Clarithromycin

500 mg

Twice daily for 10 days

Side effect

Headache, flatulence, nausea, abdominal pain, diarrhea, dry mouth, dizziness /vertigo and constipation.

Use in special group

Pregnancy: Pregnancy category of Esomeprazole is C. This drug should be used during pregnancy only if clearly needed.

Lactation: The excretion of Esomeprazole in breast milk has not been studied. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and efficacy have been established for the short-term treatment of GERD in patients of 1-17 years of age.

Contraindication

Patients with known hypersensitivity to any component of the formulation.

Precaution

Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy.

Drug Interaction

Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g.Ketoconazole, Iron salts and Digoxin).

Storage

Keep out of the reach of children. Keep below 30°C, protect from light.

Commercial Pack

Esomium 20 capsule: Each box contains 7x10’s capsule in blister pack.

Esomium 40 capsule: Each box contains 3x10’s capsule in blister pack.