COMPOSITION
Omrazol 40 Capsule: Each capsule contains Omeprazole BP 40 mg as enteric coated pellets.
PHARMACOLOGY
Omrazol (Omeprazole), the substituted benzimidazole, is an inhibitor of gastric acid secretion. Omeprazole inhibits the secretion of gastric acid by blocking the H+/K+ATPase (hydrogen-potassium-adenosine triphosphatase) enzyme system, the so –called “proton pump” of the gastric parietal cell.
INDICATION
Benign gastric and duodenal ulcer, heart burn, NSAID-associated complications, peptic ulcer associated with Helicobacter pylori, gastro-esophageal reflux disease, Zollinger-Ellison syndrome, prevention of acid aspiration syndrome, acid related dyspepsia and other hyper acidic complications.
DOSE AND ADMINISTRATION
Adults
Omrazol (Omeprazole) should be taken before meal.
Benign gastric and duodenal ulcers: 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration; in severe or recurrent cases increase to 40 mg daily; maintenance for recurrent duodenal ulcer, 20 mg once daily; prevention of relapse in duodenal ulcer : 10 to 20 mg once daily if symptoms return.
Heart burn: 20 mg once daily for 14 days.
NSAID-associated complications: NSAID-associated duodenal or gastric ulcer & gastro duodenal erosions, 20 mg once daily for 4 weeks, followed by a further 4 weeks if not fully healed; prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers, gastro duodenal lesions, or dyspeptic symptoms who require continued NSAID treatment, 20 mg once daily.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, followed by a further 4-8 weeks if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease refractory to other treatment; may be continued at 20 mg once daily.
Maintenance therapy: 10-20 mg once daily.
DOSE AND ADMINISTRATION
Zollinger-Ellison syndrome: Initially 60 mg (40+20 mg) once daily; usual range 20-120 mg daily (above 80 mg in 2 divided doses).
Gastric acid reduction during general anesthesia (prophylaxis of acid aspiration): 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Acid related dyspepsia: 10-20 mg once daily for 2-4 weeks according to response.
Use in children
Child over 2 years : Severe ulcerating reflux esophagitis, 0.7-1.4 mg/kg daily for 4-12 weeks; maximum 40 mg daily (to be initiated by hospital physician under close supervision).
Elderly
Dose adjustment is not required in the elderly. Impaired renal or hepatic function: Dose adjustment is not required in renal impairment. Patients with severe liver disease should not require more than 20 mg Omeprazole daily. Or, as directed by physician.
CONTRAINDICATION
Omrazol (Omeprazole) is contraindicated in patients with known hypersensitivity to any component of the product.
WARNING AND PRECAUTION
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 EFFECTS
Omrazol (Omeprazole) is well tolerated. But nausea, diarrhea, constipation, flatulence, abdominal pain, dizziness, headache, skin rashes may occur rarely.
USE IN PREGNANCY AND LACTATION
There are no adequate or well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the risk to the fetus. Omeprazole is excreted in breast milk. So a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
DRUG INTERACTIONS
Omrazol (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.
OVERDOSE
Oral doses up to 400 mg have not resulted in severe symptoms.
STORAGE
Store in a cool and dry place below 300 C. Protecte from light & moisture. Keep all medicines out of reach of children.
PACKING
Omrazol 20 Capsule: Each box contains 10×10’s capsules in alu-alu blister strips.
Omrazol 40 Capsule: Each box contains 5×4’s capsules in alu-alu blister strips.
