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Sunday, 16 October 2016 03:56

Onepro

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Onepro

(Esomeprazole)

Presentation

Onepro 20 tablet: Each delayed release tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.

Onepro 40 tablet: Each delayed release tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 40 mg.

 

Description

Esomeprazole (Onepro) 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, Onepro blocks the final step in acid production, thus reducing gastric acidity.

 

 

Indications and Usage

Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

Maintenance of Healing of Erosive Esophagitis

Symptomatic Gastroesophageal Reflux Disease

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Zollinger-Ellison Syndrome

Acid Related Dyspepsia

Duodenal and Gastric Ulcer

 

Dosage and Administration

Tablet: The recommended adult dosages are outlined in the table below. Onepro delayed release tablet/capsule should be swallowed whole and taken at least one hour before eating.

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 of treatment may be considered.

**If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

 

Use in Pregnancy and Lactation

In Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

 

In Lactation: The excretion of Esomeprazole in milk has not been studied. As 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.

 

Side-effects

In general, Esomeprazole was well tolerated in both short- and long-term clinical trials. The most frequently occurring adverse events (≥1%) are headache and diarrhea. Nausea, flatulence, abdominal pain, constipation and dry mouth occurred at similar rates among patients taking Esomeprazole.

 

Contraindications

Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

 

Precautions

Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Esomeprazole is an enantiomer.

 

Drug Interactions

Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with Phenytoin, Warfarin, Quinidine, Clarithromycin or Amoxicillin.  Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, Ketoconazole, Iron salts and Digoxin). Coadministration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.

 

Commercial Pack

Onepro 20 tablet: Each box contains 6 Alu-Alu blister strips of 10 tablets.

Onepro 40 tablet: Each box contains 3 Alu-Alu blister strips of 10 tablets.

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