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Omeprazole Capsule contains Omeprazole
Omeprazole Capsule side effects
Side effects reported with Omeprazole in clinical studies have included nausea, diarrhoea, constipation, flatulence, abdominal colic, paresthesia, dizziness and headache but are rare. Skin rashes, leukopenia and transient elevation of plasma activation of hepatic amino-transferases have been observed occasionally in few patients and there has been no consistent relationship with treatment.
Precautions: Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.
Warning: In long-term (2 years) studies in rats, Omeprazole produced a dose related increase in gastric carcinoid tumours. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomachs have not detected a risk from short-term exposure to Omeprazole, further human data on the effects of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumours in humans receiving long-term therapy with Omeprazole.
Omeprazole can delay the elimination of Diazepam, Phenytoin and Warfarin. Monitoring of patients receiving Warfarin or Phenytoin is recommended and a reduction of Warfarin or Phenytoin dose may be necessary when Omeprazole is added to treatment. Omeprazole does not interfere with Theophylline or Propranolol metabolism.
Pregnancy: 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.
Lactation: 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 is contraindicated in patients with known hypersensitivity to any component of the formulation.
Renal Impairment: No dosage adjustment needed
Hepatic Impairment: 100 mg/day
Pediatric Use: Safety and effectiveness in children have not been established
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