FORMULA:
Each Omeprazid Micropellet Capsule contains Omeprazole 20 mg as enteric coated, gastric acid resistant granules and as colouring agent titanium dioxide, quinoline yellow, indigotine, red iron oxide.

PHARMACOLOGICAL PROPERTIES:
Omeprazole is an antiulcer agent which inhibits the gastric acid secretion specifically. Omeprazole reduces the gastric acid secretion from parietal cells by inhibiting the (H+, K+, ATPase) proton pump, the enzyme catalysing the final step of gastric acid secretion. Omeprazole inhibits both stimulated and basal acid secretion irrespective of the stimulus. Inhibition of acid secretion is about 50% of maximum at 24 hours and the duration of inhibition lasts up to 72 hours.

INDICATIONS:

• Duodenal ulcer
• Gastric ulcer
• Peptic ulcers induced by NSAID’s
• Reflux esophagitis
• Gastroesophagial reflux disease
• Zollinger- Ellison syndrome
• Prophylaxis of acid aspiration during general anesthesia
• Duodenal and gastric ulcers, which are resistant to H2 receptor blockers.

CONTRAINDICATIONS:
Omeprazid is contraindicated in patients with known hypersensitivity to any component of the formulation.

DRUG INTERACTIONS and OTHER INTERACTIONS:
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolised by oxidation in the liver. Although in normal subjects no interactions with theophylline or propranolol was found, there have been clinical reports of interactions with other drugs metabolised via the cytochrome P450 system. (e.g., cyclosporine, disulfiram, benzodiazepines ).

DOSAGE and ADMINISTRATION:
Gastric ulcer and reflux esophagitis: The recommended dosage is 20 mg Omeprazid Micropellet Capsule once daily, given for 4 weeks. For the patients not fully healed after initial course and resistant to H2-receptor blockers, Omeprazid capsule has also been used in a dose of 40 mg once daily. Long- term maintenance treatment with Omeprazid Micropellet Capsule is not recommended.
Duodenal ulcer: The usual dose is 20 mg Omeprazid Micropellet Capsule once daily for 2 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 2 weeks treatment.
Peptic ulcers induced by NSAID therapy: The effectiveness of omeprazid in healing duodenal and benign gastric ulcers is not affected by concomitant NSAID treatment, usual duodenal ulcer treatment regimens are recommended.
H. pylori eradication in peptic ulcer disease: Omeprazid Micropellet Capsule is used with appropriate antimicrobial agents
Zollinger Ellison Syndrome: The recommended initial dosage is 60 mg Omeprazid Micropellet Capsule once daily. The dosage should be adjusted up to 180 mg individually and treatment continued as long as clinically indicated. With doses above 80 mg daily, the dose should be divided and given twice daily.
Prophylaxis of acid aspiration: For patients considered to be at risk of aspiration of the gastric contents during general anesthesia, the recommended dosage is 40 mg Omeprazid Micropellet Capsule (2 capsules) on the evening before the surgery, and 40 mg Omeprazid Micropellet Capsule (2 capsules) 1-4 hours before the surgery.

HOW SUPPLIED:
Omeprazid Micropellet Capsules: In blister packages of 14 capsules.