Eprazol 40mg

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Generic : Esomeprazole
Therapeutic : Esomeprazole

EPRAZOL

Esomeprazole

Composition :

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

Eprazol 40 Capsule: Each capsule contains Esomeprazole 40 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 in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks 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 nce 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 C. There are no adequate and well-controlled studies with Esomeprazole in Pregnant women.

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 30oC. Keep out of the reach of children.

Commercial Pack :

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

Eprazol 40 Capsule: Each box contains 5 x 6 capsules, in Alu-Alu blister pack.



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