Composition
Each vial contains:
Omeprazole equivalent to 40mg
Description
Omeprazole is a substituted benzimidazole that suppresses gastric acid secretion by specific inhibition of the H'/K' ATP ase enzyme system (proton pump) at the secretory surface of the gastric parietal cell thus blocking the final step of acid production.
Indications
It is indicated for disorders associated with hypersecretion of gastric acid such as benign gastric ulcers, duodenal ulcers , gastroesophageal reflux disease and Zollinger-Ellison syndrome.
Contraindications
Hypersensitivity to the components of the formulation.
Warnings and Precautions
DRUG INTERACTIONS
Drugs metabolised in the liver:
Omeprazole can prolong the elimination of diazepam , warfarin and phenytoin which are metabolised by oxidation in the liver.
Hence , at the time of concomitant administration , dosage adjustment should be done after careful monitoring of the patient.
Ketoconazole, ampicillin esters and iron salts : Because of its profound and long lasting inhibition of gastric acid secretion, omeprazole may interfere with the absorption of those drugs where gastric PH
is an important determinant of their bioavailability.
PREGNANCY
There are no adequate or well controlled studies of omeprazole in pregnancy. Hence a decision should be made by taking into account the benefits offered and the potential risk involved.
NURSING MOTHERS
It is not known whether omeprazole is secreted in breast milk. But becasue of the potential for adverse effects , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to mother.
PAEDIATRIC USE
Safety and effectiveness has not been established.
OTHERS
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Side Effects
Nausea , headache , diarrhoea , constipation and flatulence are reported but occur rarely. These events are mild and transient and there has been no consistent relationship with treatment.
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