OMEP Injection

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

Each vial contains lyophilized Omeprazole Sodium BP equivalent to Omeprazole 40 mg.

Packaging

Each box contains one vial of lyophilized Omeprazole Sodium powder with 1 ampoule of 10 ml Sodium Chloride 0.9% Injection, 10 ml disposable syringe, bandage and alcohol pad.

Dosage & Administration

Omep IV Injection: Indication Dose Prophylaxis of acid aspiration 40 mg 1 hour before surgery Treatment in patients where oral therapy is inappropriate e.g. in severely ill patients with reflux esophagitis, duodenal ulcer, gastric ulcer etc. 40 mg once daily Zollinger-Ellison Syndrome Recommended initial dose is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily. Method of administration: Injection: Omeprazole IV injection is obtained by adding 10 ml Sodium Chloride 0.9% to the vial containing powder. After reconstitution, the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 ml per minute. The reconstituted IV injection should be used within 4 hours if stored at room temperature. Infusion : The content of vial must be dissolved in 100 ml Sodium Chloride 0.9% injection for infusion or 100 ml 5% dextrose injection. The reconstituted solution should be used within 12 hours when omeprazole is dissolved in Sodium Chloride 0.9% injection and within 6 hours when dissolved in 5% dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug. Omep IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more.

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.