OMEP – 20 Capsule

Therapeutic Class

Antacids, Antireflux Agents & Antiulcerants

Indications

Omep Capsule: Omep is indicated for short and long term treatment of duodenal ulcer, gastric ulcer, resistant ulcer, NSAIDs-induced peptic ulcer and gastroduodenal erosions, erosive reflux esophagitis, refractory reflux esophagitis, acid reflux disease, acid related dyspepsia, Zollinger-Ellison syndrome. Omep IV Injection: Prophylaxis of acid aspiration. Treatment in patients where oral therapy is inappropriate e.g. in severely ill patients with reflux esophagitis, duodenal ulcer, gastric ulcer etc. Zollinger-Ellison syndrome.

Chemical Composition

Omeprazole BP 20 mg

Packaging

Box containing 100 capsules in alu-alu blister pack.

Dosage & Administration

Omep Capsule: Omep capsule should be taken before meal. Duodenal ulcer: 20 mg once daily for 4 weeks. In severe cases 40 mg once daily for 4 weeks. Gastric ulcer: 20 mg once daily for 8 weeks. In severe cases 40 mg once daily for 8 weeks. Resistant ulcer: 40 mg daily for 4 weeks. For long term therapy, the maintenance dose is 40 mg daily. Maintenance of recurrent duodenal ulcer: 20 mg once daily. NSAIDs induced peptic ulcer and gastroduodenal 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 NSAIDs associated gastroduodenal lesions that require continued NSAIDs treatment, 20 mg once daily. Gastro Esophageal Reflux Disease (GERD) : Adult: 20 mg once daily for 4 weeks, continued for further 4-8 weeks if not fully healed. Children aged 1-16 years: Body weight 10 Kg to <20 Kg: 10 mg once daily for 4-8 weeks & 20 Kg: 20 mg once daily for 4-8 weeks. Refractory reflux esophagitis: 40 mg once daily for 8 weeks, may be continued at 20 mg once daily. Acid reflux disease: For long term management, 10 mg daily, increasing to 20 mg once daily if symptoms return. Acid related dyspepsia: 10-20 mg once daily for 2-4 weeks according to response. Zollinger-Ellision Syndrome: 60 mg once daily adjusted individually and continued as long as necessary. Most patients will be effectively controlled with 20-120 mg daily. Dosage above 80 mg should be divided and given twice daily.

Contraindications

Omeprazole is contraindicated in patients who have known hypersensitivity to Omeprazole or any component of the formulation.

Side Effects

Omep is generally well tolerated. Nausea, diarrhoea, flatulence, abdominal pain, constipation, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

Drug Interaction

Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. There is no evidence of an interaction with theophylline, propranolol or antacid