Ezetimibe
Ezetimibe localises at the brush border of the small intestine and inhibits absorption of cholesterol via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This results in decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and increased clearance of cholesterol from the blood.
The recommended dose of Ezetimibe is 10 mg once daily. Ezetimibe can be administered with or without food.
Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Emibe increased cholesterol in the gallbladder bile. Coadministration of Emibe with fibrates is not therefore recommended until use in patients is studied.
Hypersensitivity to any component of this medication. The combination of Ezetimibe with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.
Clinical studies of Emibe (administered alone or with an HMG-CoA reductase inhibitor) demonstrated that Emibe was generally well tolerated. The overall incidence of adverse events reported with Emibe was similar to that reported with placebo, and the discontinuation rate due to adverse events was also similar for Emibe and placebo.
There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus
Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy. Renal and hepatic impairment. Pregnancy and lactation.
No cases of overdosage with Emibe have been reported. Administration of Emibe,50 mg/day, to 15 subjects for up to 14 days was generally well tolerated. In the event ofan overdose, symptomatic and supportive measures should be employed.
Ezetimibe
Store in a cool & dry place protected from light and moisture. Keep out of reach of children.
Pediatric Use-10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Emibe is administered with statin, the dosage instructions for statin, in adolescents should be consulted.Children < 10 years: Emibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.
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