Composition:
Orpra 20 capsule: Each capsule contains omeprazole BP 20 mg as enteric coated Pellets.

Pharmacology:
Omeprazole is a substituted benzimidazole, is an inhibitor of gastric acid secretion. Omeprazole inhibits secretion of gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (commonly known as ‘proton pump’) in the gastric parietal cell. It is effective for the treatment of gastric and duodenal ulcers and particularly for erosive reflux esophagitis. Orally administered Orpra is absorbed rapidly but to a variable extent. Following absorption Orpra is almost completely metabolized and rapidly eliminated mostly in the urine. Although the elimination half-life from plasma is short, being reported to be 0.5 to 1.5 hours, its duration of action with regard to inhibition of acid secretion is much longer and it is suggested that its distribution to the tissues particularly to the gastric parietal cells accounts for this action. Orpra is highly bound (about 95%) to plasma proteins.

Indication:

• Benign gastric and duodenal ulcers including those complicating NSAID therapy
• Erosive reflux esophagitis
• Hypersecretion disorder of gastric acid
• Zollinger-Ellison syndrome

Dosage and Administration:

• Benign gastric and duodenal ulcers including those complication NSAID therapy: 20 mg daily for 4 weeks in duodenal ulcer or 8 weeks in gastric ulcer, in severe cases the dose may be increased to 40 mg daily; long-term use is not recommended.
• Healing of reflux esophagitis: 20 mg daily for 4 weeks, followed by a further 4-8 weeks if not fully healed: 40 mg daily has been given for 8 weeks in reflux esophagitis refractory to other treatment; may be continued at 20 mg daily.
• Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (above 80 mg in 2 divided doses). Larger doses of up to 180 mg daily in divided doses may be used or as prescribed by the physicians.

Contraindication:
There are no known contraindications to the use of Omeprazole.

Precaution and Warning:
Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Omeprazole is instituted as treatment may alleviate symptoms and delay diagnosis.

Side Effect:
Omeprazole is well tolerated. Nausea, diarrhea, abdominal colic, paresthesia, dizziness, and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

Use in Pregnancy and Lactation:
Avoid in pregnancy unless there is no safer alternative. Breastfeeding should be discontinued if the use of Omeprazole is considered essential.

Drug Interaction:
Omeprazole can delay the elimination of diazepam, phenytoin, and warfarin, reduction of warfarin or phenytoin dose may be necessary when omeprazole is added to treatment. There is no evidence of an interaction with theophylline, propranolol, or antacids.

Storage:
Store below 30°C, in a cool & dry place. Keep away from light. Keep out of the reach of children.

Pack Size:
Orpra 20 Capsule: Each box contains 10 x 10 capsules in Alu-Alu blister pack.