Omeprazole capsule

OMEPRAZOLE Capsule

COMPOSITION
Each capsule contains Omeprazole pellet equivalent to Omeprazole 20 mg.

PHARMACOLOGY
Omeprazole is an antisecretory agent, benzimidazole derivate which suppress gastric acid secretion by specific inhibition of H+/K+ ATP-ase enzyme (proton pump) at the secretory surface of the parietal gastric cells at pH below 4. Omeprazole which is bonding with proton (H+) will change rapidly into sulfonamide an active inhibitor proton pump.
The oral administration of Omeprazole inhibits the gastric acid secretory and pentagastric stimulation.

INDICATION

• Short-term treatment of duodenal ulcer and duodenal ulcer that are not responsive to H2 receptor antagonist.
• Short-term treatment of gastric ulcer.
• Treatment of erosive/ulcerative esophagistis reflux which has been diagnosed by endoscopy.
• Long-term treatment of Zollinger Ellison syndrome.

CONTRAINDICATION

Patient wich is known hypersensitive to Omeprazole.

DOSAGE AND ADMINISTRATION

Adults :

The recommended dose is 20 to 40 mg once daily swallowed with adequate water.

• Patient with duodenal ulcer symptom : therapy and treatment within 2 weeks. If the initial phase of therapy doesn't achieve completely healing, the patients may require an additional 2 weeks of therapy.
• Patient with gastric ulcer syndrome or erosive/ulcerative esophagistis reflux may require therapy and treatment within 4 weeks. Some patients may require an additional 4 weeks of therapy.
• In patient which is difficult to achieve completely healing with another therapy, may requires 40 mg Omeprazole daily and healing will occur within 4 weeks (patient with duodenal ulcer) or 8 weeks (patient with gastric ulcer or erosive/ulcerative esophagistis reflux).
• Patient with Zollinger Ellison syndrome :
• Usual starting dose : 20 - 160 mg once daily, dosage should be adjusted to individual patient needs and should be administered as long as clinically indicated. Doses above 80 mg should be divided and given twice daily.
• Omeprazole capsules should be taken before meal.
• Capsule should not be opened, chewed, or crushed and should be whole swallowed.

No dosage adjustment is necessary for patients with renal impairment, hepatic dysfunction or for the elderly.

Children :

There is no experience with Omeprazole in children.

ADVERSE REACTION

Generally Omeprazole can be tolerated well. High dosage and long-term treatment of Omeprazole may stimulate ECL cells (enterochromaffin-like cells).

It should be monitored to bacterial overgrowth.

WARNING AND PRECAUTION

• It should take into account the sustained effect of hypochlorhydria and hypergastrinemia if long-term therapy of Omeprazole is administered.
• If the daily dose is greater than 80 mg, it should be divided and given twice daily.
• Omeprazole should not be administered during pregnancy or lactation unless the use of drugs is considered essential.

DRUG INTERACTION

• Omeprazole can prolong the elimination of drugs metabolized via cytochrom P-450 in the liver such as Diazepam, Warfarin, and Phenytoin. Patient should be monitored when also taken Warfarin, and Phenytoin therapy, and decrease the dose of Warfarin and Phenytoin if it is possible.
• There is no evidence interaction between Omeprazole with Propanolol and Thephylline.
• Omeprazole may reduce the absorption of drugs if their absorption depend on gastric acid such as Ketoconazole, Ampicillin esters, and Iron salts.

STORAGE

Store at room temperature (below 30 C).

PRESENTATION

Box, 3 strips @ 10 capsules.

Source : Enclosed brochure of Novell Pharmaceutical Laboratories Bogor-Indonesia