Omepak

Omepak

Omepak Capsules
Composition:
Each capsule contains:
Omeprazole 10, 20or40 mg.
Properties:
Omeprazole belongs to a new class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic properties, but 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 the gastric mucosa, omeprazole has been characterized as a proton -pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related & leads to inhibition of both basal & stimulated acid secretion irrespective of the stimulus.
After oral administration, the onset of the antisecretory effect of omeprazole occurs within one hour, with the maximum effect occurring within two hours.
Inhibition of secretion is about 50% of maximum at 24 hours & the duration of inhibition lasts up to 72 hours. The antisecretory effect thus lasts far longer than would be expected from the very short plasma half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme.
Single daily oral doses of omeprazole ranging from a dose of 10mg to 40mg have produced 100% inhibition of 24 hour intragastric acidity in some patients.
Absorption is rapid, with peak plasma level of omeprazole occurring within 0.5 to 3.5 hours.
Absolute bioavailability (compared to intravenous administration )is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour. Protein binding is approximately 95%.
Indications & Dosage:
Peptic ulcer & reflux oesophagitis: 20-40 mg as a single daily dose for 4-8 weeks.
Zollinger- Ellison syndrome: 60-80 mg & up to 180mg daily in divided doses for long term treatment.
Acid related dyspepsia & heartburn: 10-20 mg once daily for 2- 4 weeks according to response.
For maintenance of management of peptic ulcer: 10 mg once daily.
For prevention of relapse of peptic ulcer: 10 mg once daily.
Side effects:
Omepak is well tolerated and treatment of patients with Zollinger - Ellison syndrome with doses of 180- 360 mg/day for up to 4 years has not caused significant side effects.
Nausea, diarrhea, abdominal colic, paraesthesia, dizziness & headache have been stated to be generally mild, transient & do not require a reduction in dosage. ______________
_____ Contraindications:
Hypersensitivity to omeprazole.
_____ Precautions:
It must be taken before meals and the capsule shouldn’t be opened, chewed, or crushed.
Drug interactions:
- Since Omepak interacts with cytochrome P450 in vitro, inhibition of hepatic metab.plism of certain drugs may be important.
- Although the clearance of diazepam is reduced by about 50%, Omepak has only minor effects on the elimination of single oral doses of phenytoin. It also increases the anticoagulant activity of warfarin.
Use during pregnancy & lactation:
- Omepak is used during pregnancy only if the potential benefit justifies the potential risk to the
fetus. -
- Because of the potential serious adverse reactions in nursing mothers from Omepak, a decision should be made whether to discontinue nursing orto discontinue the drug, taking into account the importance of the drug to the mother.
Storage:
Keep at temp. not exceeding 30 C, away from heat, light and moisture.
Keep medicine out of reach of children. I I
Presentation: j
Boxofl4capsules(lOmg).
Box of 7 or 14 capsules (20mg).
Boxof7orl4capsules(4Omg).
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Produced by ii
SEDICO Pharmaceutical Co.
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