Primary Hypercholesterolemia: Emibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone. Emibe monotherapy ... Read more Primary Hypercholesterolemia: Emibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone. Emibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia in whom a statin is considered inappropriate or is not tolerated. Prevention of Cardiovascular Events: Emibe is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin. Homozygous Familial Hypercholesterolaemia (HoFH): Emibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). Homozygous Sitosterolemia (Phytosterolemia): Emibe is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolemia.
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.
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10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Ezetimibe is administered with statin, the dosage instructions for statin, in adolescents should be consulted. Children <10 years: Ezetimibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy. Use in hepatic impairment : No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with Ezetimibe is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score>9) liver dysfunction. Use in renal impairment : No dosage adjustment is required for renally impaired patients
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. The following adverse reactions were observed in patients treated with Emibe: Common or very common: Fatigue, gastro-intestinal disturbances, headache, myalgia. Rare: Anaphylaxis, angioedema, arthralgia, hepatitis, hypersensitivity reactions, rash. Very rare: Cholecystitis, cholelithiasis, myopathy, pancreatitis, raised creatine kinase, rhabdomyolysis, thrombocytopenia.
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.
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.
Concurrent administration of Emibe with a specific HMG-CoA reductase inhibitor should be in accordance with the product labeling for that HMG-CoA reductase inhibitor.