Gem-20
Omeprazole Capsule

PRESENTATION
Each Gem-20 capsule contains 20 mg of Omeprazole as enteric coated gastroresistant granules.

CLINICAL PHARMACOLOGY
Omeprazole is one of a new family of agents which inhibit gastric secretion. The exact mechanism of action of Omeprazole is not certrain. The substituted benzimidazoles of Omeprazole suppresss gastric acid secretion by inhibition of the H+/K+ ATpase enzyme system at the secretory surface of the acid (proton) pump within the gastric mucosa, Omeprazole has been characterized as a gastric acid pump inhibitor, in that it blocks the final step of acid production.

Omeprazole is rapidly absorbed following oral administration and is high bound (about 95%) to plasma proteins. Omeprazole is almost completely metabolized in the liver. Fecal excretion accounts for 20%, and the remainder is excreted in the urine. The Bioavailability is highly variable and dependent on formulation (50-65%).

INDICATIONS
Gem-20 has been found to produce faster symptom relief and higher healing rates in a greater precentage of patients than either Climetidine or Ranitidine, confirming the 'therapeutic gains' achievable with Proceptin over existing therapies. Omeprazole offers significant therapeutic gains in the treatment of acid related diseases : healing rates are high in duodenal ulcer, gastric ulcer and erosive reflux esophagitis; acid production is controlled effectively in Zollinger-Ellison Syndrome, and symptom relief is prompt and sustained in all indications. Less clearcut indications where benefit might be expected but data are limited include : Prevention of stress ulceration, Prevention of the acid aspiration syndrome, and Treatment of upper gastrointestinal bleeding.

DOSAGE AND ADMINISTRATION
Gem-20 should be taken before meals. Patients with severe liver disease should not require more than 20 mg Omeprazole daily. Long-term maintenance treatment with Omeprazole is not recommended.

CONTRAINDICATIONS
Omeprazole capsule is contraindicated in patients with known hypersensitivity to any component of the formulation.

USE IN PREGNANCY AND LACTATION
As with all new drugs, omeprazole should not be given during pregnancy and lactation unless its use is considered essential.

PREDIATRIC USE
Safety and effectiveness in children have not been established.

ADVERSE EFFECTS
Side effects reported with Omeprazole in clinical studies have included nausea, constipation, flatulence, abdominal colic, parasthesia, dizziness and headache but are rare. Skin reshes, leukopenia and transient elevation of plasma activation of hepatic amino-transferases have been observed occasionally in few patients and there has been no consistent relationship with treatment.

PRECAUTIONS
Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.

WARNINGS
In long-term (2 years) studies in rats, Omeprazole produced a dose-related increase in gastric carcinoid tumors. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomach have not detected a risk from short-term exposure to Omeprazole.

DRUG INTERACTIONS
Omeprazole can delay the elimination of diazepam, phenytoin and warfarim. Monitoring of patients receiving warfarim or phenytoin is recommened and a reduction of warfarin or phenytion dose may be necessary when omeprazole is added to treatment. Omeprazole does not interfere with theophylline or propranolol metabolism.

INFORMATION TO PATIENTS
Patients should be cautioned that Gem-20 should not be opened, chewed or crushed and should be swallowed whole.

Packaging
Gem-20 Capsule : Box contains 30 capsules (3x10's) in blister strips.