OMESAFE Capsule

Therapeutic Class

Antacids, Antireflux Agents & Antiulcerants

Chemical Composition

Each Capsule contains :

Omeprazole BP 20 mg (As enteric coated granules)

Packaging

10 x 10's / Box

Dosage & Administration

Duodenal ulcer, Benign gastric ulcer: 20mg/day 4-8 weeks Max daily dose :40mg. NSAID-associated duodenal or gastric ulcer and gastroduodenal erosions :20mg once daily for 4 weeks. Gastro-Oesophageal Reflux Disease: 20mg/day 4-8 weeks. Increase to 40mg/day for 8 weeks if symptoms persist. Maintenance dose : 20mg/day. Zollinger-EIIison Syndrome :Start at 60mg once daily. Usual range 20-120mg/day (above 80mg in 2 divided doses). Prophylaxis of acid aspiration during anaesthesia 40mg on the preceding evening then 40 mg 2-6 hours prior to surgery. Acid Related Dyspepsia: 10-20mg/day for 2-4 weeks.

Contraindications

Hypersensitivity, neonates, lactation

Warning & Precautions

Exclude the presence of gastric malignancy. Impaired renal and hepatic functions. Paediatrics : Not recommended. Pregnancy: Safety not established. Lactation: Safety not established. Elderly: No special problem

Side Effects

Nausea, constipation and flatulence, diarrhoea, skin rash, headache. Increased risk of enteric infections due to reduced acid secretion.

Drug Interaction

Diazepam: Half life of diazepam is increased. Phenytoin: Increased plasma concentration of phenytoin Oral anticoagulants: May prolong the elimination of warfarin. Cyclosporine, Disulfiram : Omeprazole interferes with metabolism of these drugs Ketoconazole, Ampicillin esters, Iron salts: Omeprazole may interfere with absorption of these drugs where gastric pH is a determinant factor for their bioavailability. Interaction with food: Absorption may be delayed.