Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. 10 mg PO once daily. The effects of ezetimibe coadministered with simvastatin compared to simvastatin monotherapy were evaluated in 142 boys and 106 postmenarchal girls, aged 10—17 years, with heterozygous familial hypercholesterolemia. Contains Nonbinding Recommendations Draft Guidance on Ezetimibe This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) Ezetimibe (Zetia) is an expensive drug used to lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet. Vytorin is a combination of ezetimibe and simvastatin that is used for treating high levels of cholesterol in the blood. Vytorin reduces total cholesterol and low density lipoprotein (LDL or bad ) cholesterol while it increases high density lipoprotein (HDL or good ) cholesterol. ezetimibe Ezetrol (UK), Zetia Pharmacologic class: Cholesterol absorption inhibitor Therapeutic class: Antihyperlipidemic Pregnancy risk category C Action Inhibits cholesterol absorption in the intestine, decreasing intestinal delivery of cholesterol to the liver and increasing systemic cholesterol clearance. Net effect is decreased serum. Usual starting dose is ezetimibe 10 mg/simvastatin 10 mg or ezetimibe 10 mg/simvastatin 20 mg PO once daily in the evening. May initiate at ezetimibe 10 mg/simvastatin 40 mg PO once daily in the evening for patients requiring a larger reduction in LDL-C (greater than 55%). LIPTRUZET ® (ezetimibe and atorvastatin) Tablets for Oral Use. DESCRIPTION. LIPTRUZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. Abstract Serum aminotransferase elevations are a commonly known adverse effect of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy. However, hepatotoxic events have not been widely published with ezetimibe or the combination ZETIA ® (ezetimibe) Tablet, for Oral Administration. DESCRIPTION. ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols.