OMEPRAZOLE Capsule

Omeprazole is a proton pump inhibitor indicated for:

- Treatment in adults of duodenal and gastric ulcer

- Treatment in adults and children of gastroesophageal reflux disease (GERD) and maintenance of healing of erosive esophagitis

- Helicobacter Pylori eradication in peptic ulcer disease

- Zollinger-Ellison syndrome

Dosage and Administration

These capsules should be taken before eating and should be swallowed whole. Antacids may concomitantly be used.

Short term treatment of active duodenal ulcer

20mg once daily.

Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

Gastric Ulcer

40mg once daily for 4-8 weeks.

Gastroesophageal Reflux Disease (GERD)

No esophageal lesions: 20mg daily for up to 4 weeks.

With erosive esophagitis and accompanying symptoms due to GERD is 20mg daily for 4-8 weeks.

H.pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

Triple therapy (Omeprazole/clarithromycin/amoxicillin) - omeprazole 20mg + clarithromycin50mg + amoxicillin 1000mg each given trice daily for 10 days.

In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20mg once daily is recommended for ulcer healing and symptom relief.

Pathological Hypersecretory Conditions

The dosage varies with the individual patient.

The recommended adult oral starting dose is 60mg once daily.

Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.

Doses up to 120 mg 3 times daily have been administered.

Daily dosage of greater than 80mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

In patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation.

Hypersensitivity reactions include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis and urticaria.

Adults: Most common adverse reactions in adults are headache, abdominal pain, nausea, diarrhoea, vomiting, and flatulence

Pediatric patients (1-6 years of age): Safety profile similar to that in adults, except that respiratory system events and fever were the most frequent reported reactions in pediatric studies.

See the package insert about the details below:

- atazanavir and nelfinavir

- saquinavir

- drugs for which gastric pH affects bioavailability (e.g. ketoconazole, iron salts, erlotinib, ampicillin esters, and digoxin)

- clopidogrel

- cilostazol

- drugs metabolized by CYP450 (e.g. diazepam, warfarin, phenytoin, cyclosporine, disulfiram, benzodiazepines)

- warfarin

- inhibitor of CYP2C19 and 3A4 (e.g. voriconazole)

- tacrolimus

- methotrexate

- Symptomatic response does not preclude the presence of gastric malignancy

- Atrophic gastritis has been noted with long-term therapy

- PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhoea

- Avoid concomitant t use of omeprazole with clopidogrel

- Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine

- Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.

- Avoid concomitant use of Miracid with St. John’s Wort of Rifampin due to the potential reduction in omeprazole concentrations.

- Increase in intragastric pH may result in hypergastrinemia and increased Chromogranin

A levels which may interfere with diagnostic investigations for neuroendocrine tumors.

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after rapid disappearance from plasma, omeprazole can be found within the gastric mucosa for a day or more.