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.
Pharmacology
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
Contra-indication
Patients with known hypersensitivity to any component of the formulation.
|
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 |
|
|
|
|
Esomeprazole |
20 mg |
Twice daily for 10 days |
|
Amoxicillin |
1000 mg |
Twice daily for 10 days |
|
Clarithromycin |
500 mg |
Twice daily for 10 days |
Warning and precaution
Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy.
Side effects
Headache, flatulence, nausea, abdominal pain, diarrhea, dry mouth, dizziness /vertigo and constipation.
Use in pregnancy & lactation
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.
Use in children & adolescents
Safety and efficacy have been established for the short-term treatment of GERD in patients of 1-17 years of age.
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).
Overdose
There is no experience to data with deliberate overdose. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Esomium 20 capsule: Each box contains 7x10's capsule in blister pack.
Esomium 40 capsule: Each box contains 3x10's capsule in blister pack.
