Gastril-20 Capsule : Each capsule contains Omeprazole BP 20 mg as enteric-coated pellets.
Gastril IV Injection: Each vial contains lyophilized Omeprazole Sodium BP equivalent to Omeprazole 40 mg.
Omeprazole is a specific inhibitor of the gastric proton pump (H+/K+ ATPase) in the parietal cell. It inhibits acid secretion by binding to the H+/K+ ATPase enzyme.
Gastril 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.
Gastril 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.
Dosage & Administration:
Gastril Capsule :
Gastril 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.
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.
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.
Gastril IV Injection :
|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:
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 as a maximum rate of 4 ml per minute. The reconstituted IV injection should be used within 4 hours if stored at room temperature.
Omeprazole is contraindicated in patients who have known hypersensitivity to Omeprazole or any component of the formulation.
Warning & Precaution:
Impaired renal function : In such cases, dosage adjustment is not required.
Impaired hepatic function : As bioavailability and half-life is increased in patient with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg.
The elderly : Dosage adjustment is not required in the elderly.
Gastril 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.
Pregnancy and Lactation:
There are no adequate and well-controlled studies on the use of Omeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Omeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.
Omeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. There is no evidence of an interaction with theophylline, propranolol or antacid.
Symptoms were transient, and no serious clinical outcome has been reported with Omeprazole overdose. No specific antidote for Omeprazole overdose is known. Omeprazole is extensively bound with protein and is, therefore, not readily dialyzable. In the event of overdose, treatment should be symptomatic and supportive.
Gastril -20 Capsule : Box containing 100’s capsules in alu-alu blister pack.
Gastril IV Injection : Box containing one vial with 1 ampoule of 10 ml Sodium Chloride 0.9% Injection and 10 ml disposable syringe.