EMEP

Esomeprazole

Description:

Esomeprazole is the S-isomer of Omeprazole, proton pump inhibitor. Esomeprazole suppresses gastric acid secretion by specific inhibition of the H⁺/K⁺-ATPase in the gastric parietal cell. By acting specially on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.                                                                 

Composition:

Each enteric coated tablet contains Esomeprazole magnesium trihydrate INN equivalent to Esomerprazole  20 mg.

Indictaions:

¨ For the treatment of heart burn and other symptoms associated with GERD

¨ For the healing of erosive esophagitis.

¨ For maintenance of healing of erosive esophagitis

¨ In duodenal ulcer

¨ In combination with amoxycillin, clarithromycin, esomeprazole is used for the treatment of   H. pylori infection and duodenal ulcer disease to eradicate H. pylori.

Dosage & administration:

Esomeprazole tablet should be taken one hour before meal.

Recommended adult dosage schedule of Emep

* The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks treatment may be considered.

Contraindications:

Esomeprazole is contraindicated in patients who have known hypersensitivity to Esomeprazole or any component of the formulation.

Side-effects:

In general, esomeprazole is well tolerated in both short and long term use. Adverse events reported with esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth.

High risk groups:

Pregnancy: Pregnancy Category: B; There are no adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing mother: The excretion of Esomeprazole in milk has not been studied. Because Esomeprazole is likely to be excreted in human milk, 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.

Children: Not recommended.

Geriatric patients: No dosage adjustment is necessary.

Renal insufficiency: No dosage adjustment is necessary.

Hepatic insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment a dose of 20 mg of Esomeprazole should not be exceeded.

Drug Interactions:

Esomeprazole is extensively metabolized in the liver. Drug interactions studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxycillin. 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:

Protect from light. Store in a cool and dry place. Keep out of the reach of children.

Packing:

Each box contains 6x10’s tablets in Alu-Alu pack.