Esovir 20 Capsule : Each capsule contains Esomeprazole USP 20 mg as enteric coated pellets.
Esovir is indicated for the treatment of heartburn, erosive esophagitis, gastro-esophageal reflux disease, peptic ulcer, duodenal ulcer, NSAID-associated gastric ulcer, Zollinger-Ellison syndrome.
Esomeprazole is contraindicated in those patients who have known hypersensitivity to any components of the formulation.
Pregnancy Category B
Teratology studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Esomeprazole. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Because Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Most common side effects in adult use (>18 years) (incidence>1%) : Headache, diarrhea, nausea, flatulence, abdominal pain, constipation and dry mouth.
Most common side effects in paediatric use (1-17 years) (incidence>1%) : Headache, diarrhea, abdominal pain, nausea and somnolence.
Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia. When using in combination with antibiotic, refer to the prescribing information of the respective antibiotics.
Esomeprazole appears to be a selective inhibitor of the cytochrome p450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Esomeprazole on the oral combined contraceptive pill. Physiological Changes similar to those found with omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.
Store at room temperature and protected from light. Keep all medicines out of reach of children.
Esovir 20 Capsule : Each box contains 60 capsules in Alu-Alu blister pack.