Class: Gastrointestinal System
Dosage Form: Capsules
Description: Proton pump inhibitor for the treatment of peptic ulcer
Omeprazole……………20 and 40mg
Pepzol (Omeprazole) is the first H+, K+ adenosine triphosphate antagonist available for clinical use.
Pepzol inhibits the gastric (H+, K+) ATP as membrane-bound proton pump in the parietal cell that is the final step in the secretion of gastric acid, in a highly selective and dose-related mechanism of action.
Pepzol inhibits basal as well as stimulated gastric secretion irrespective of the stimulus without any effect on acetylcholine or histamine receptors. Pepsin and intrinsic factor secretion are also unaffected.
The action of Pepzol is of rapid onset and persists for 24 to 72 hours.
Control of gastric acid secretion is achieved with once daily dosing.
Pepzol is indicated in duodenal or gastric ulcers with or without bleeding complications and resistant to conventional therapy (H2-receptor antagonists).
A known hypersensitivity to omeprazole.
Since omeprazole is metabolised via cytochrome P-450, inhibition of hepatic metabolism of certain drugs may be of of potential importance. Monitoring of patients receiving warfarin is recommended, and a reduction of dose of warfarin may be necessary. The clearance of diazepam is reduced by about 50%. Omeprazole has only minor effects on the elimination of single oral dose of phenytoin. No interaction with propranolol, theophylline of concomitant administered antacid has been found.
Omeprazole is well tolerated. Rarely, transient and mild nausea, headache, diarrhea, constipation or flatulence may occur.
Dosage and Administration:
1.Gastric ulcer or reflux oesophagitis:
- 20 – 40 mg once daily in the morning for 4-8 weeks
- Patients who may not have completed healing after four weeks of treatment, may receive an additional four weeks of therapy
2. Duodenal ulcer:
- 20 – 40 mg once daily in the morning for 2-4 weeks
- Patients who may not have completed healing after two weeks of treatment, may receive an additional two weeks of therapy
3. Zollinger-Ellison Syndrome:
- The recommended initial dose is 60 – 80 mg daily
- Daily doses of 20 -120 mg may be given
- Doses above 80 mg daily should be divided into two doses
- The dose should be adjusted individually and treatment should be continued as long as clinically indicated
- Dose adjustment in patients with impaired renal or liver function is not required
- No dose adjustment is necessary in the elderly
- There is no experience with omeprazole in children
Single oral doses of up to 160 mg daily have been well tolerated. There is no information available on the effect of overdosage in man.
Pregnancy and Lactation:
As with all new drugs, omeprazole should not be given during pregnancy and lactation unless it is considered essential.
The possibility of malignancy should be excluded.
Box of 14 capsules.
To be stored at temperature 25°C, away from light and humidity.