Eprazol-20 mg

Generic : Esomeprazole
Therapeutic : Esomeprazole

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Composition :

Eprazol  20  Capsule:  Each  capsule  contains  Esomeprazole  20  mg  as Esomeprazole Magnesium Trihydrate USP in enteric coated pellets.

Description :

Esomeprazole is the s-isomer of Omeprazole. It is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase inthe gastric parietal cell. By acting specifically on the proton pump, Esomeprazoleblocks the final step in acid production, thus reducing gastric acidity.

Indications :

•                 Gastro-esophageal reflux disease (in the presence of erosive reflux esophagitis)
•                 Symptomatic treatment of Gastro-esophageal reflux disease (in the absence
•                 of esophagitis)
•                 NSAID associated gastric ulcer
•                 Duodenal ulcer associated with Helicobacter pylori
•                 Zollinger-Ellison syndrome

Dosage and Administration :

Esomeprazole should be taken one hour before meal. According to disease pattern, the recommended dosage & administration:

•                 Gastro-esophageal reflux disease (in the presence of erosive reflux  esophagitis),
• 40 mg once daily for 4 weeks, continued for further 4 weeks if not fully healed or symptoms persist
•                 Symptomatic treatment of Gastro-esophageal reflux disease (in the absence of
• esophagitis), 20 mg once daily for up to 4 weeks, then 20 mg daily when required
•                 NSAID associated gastric ulcer, 20 mg once daily for 4-8 weeks
•                 Duodenal ulcer associated with Helicobacter pylori

 Zollinger-Ellison syndrome, initially 40 mg twice daily, adjusted according to response; usual range 80-160 mg daily

Usual pediatric dose for Gastro-esophageal reflux disease: Short-term treatment: 1-11 years old: 10 mg once daily for up to 8 weeks, 12-17 years old: 20-40 mg once daily for up to 8 weeks

Side effects :

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

Use in special group :

Pregnancy: Pregnancy category of Esomeprazole is B. 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.

Contraindications :

Patients with known hypersensitivity to any component of the formulation.

Precautions :

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 away from light and store below 30C. Keep out of the reach of children.

Commercial Pack :

Eprazol 20 Capsule: Each box contains 6 x 10 capsules, in Alu-Alu blister pack.

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