Homozygous Familial Hypercholesterolemia (HoFH) The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Cholesterol absorption inhibitor
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.
Hyperlipidaemias;Homozygous familial sitosterolaemia: Adult: 10mg once daily.
Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetimibe increased cholesterol in the gallbladder bile. Coadministration of Ezetimibe with fibrates is not therefore recommended until use in patients is studied.
Hypersensitivity; moderate to severe liver disease or unexplained serum transaminase elevation. Children <10 yr, lactation. Renal or mild hepatic impairment. Monitor LFTs. Immediately discontinue ezetimibe & any HMG-CoA reductase inhibitor or fibrate if myopathy is diagnosed or suspected. Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy.
Abdominal discomfort, headache, dizziness, sinusitis, pharyngitis; diarrhoea, chest pain, arthralgia, myalgia, resp infection & fatigue.
There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. No relevant published information exists on the use of ezetimibe during breastfeeding. Because of a concern with disruption of infant lipid metabolism, ezetimibe is best avoided during breastfeeding. An alternate drug is preferred, especially while nursing a newborn or preterm infant. Ezetimibe treatment in combination with a statin (e.g., atorvastatin, simvastatin) should be avoided in nursing mothers.
In clinical studies, administration of Ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolaemia for up to 56 days, was generally well tolerated. In animals, no toxicity was observed after single oral doses of 5000 mg/kg of Ezetimibe in rats and mice and 3000 mg/kg in dogs. A few cases of overdosage with Ezetimibe have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
To be dispensed only by or on the prescription of registered physician. Keep out of the reach of children. Store below 30°C. Keep in a cool & dry place. in order to protect from light and moisture
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