OMESAFE Capsule

Therapeutic Class

Antacids, Antireflux Agents & Antiulcerants

Indications

Duodenal ulcer, Benign gastric ulcer: 20mg/day 8 weeks Max daily dose :40mg NSAID-associated duodenal or gastric ucler 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.

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-Ellison 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 Pregnancy Lactation Elderly

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.