VYTORIN(ezetimibe/simvastatin)Tablets
ezetimibe/simvastatin
Drug Summary
CLASSES
HMG-CoA Reductase Inhibitors/Statins and Other Lipid Modifying Agent Combinations
DEA CLASS
Rx
DESCRIPTION
Oral antilipemic combination of a potent cholesterol absorption inhibitor (ezetimibe) and HMG-CoA reductase inhibitor (simvastatin); results in synergistic cholesterol-lowering effects; 10—80 mg of simvastatin with ezetimibe achieves LDL reductions of approximately > 51%
Used for primary hypercholesterolemia or mixed hyperlipidemia; also effective for homozygous familial hypercholesterolemia
Myopathy, including rhabdomyolysis, is greater in patients receiving 80 mg/day of simvastatin compared to lower doses or other statin therapies; therefore, 10/80 mg dose is restricted to patients who have taken 10/80 mg/day chronically (e.g. >= 12 months) without evidence of myopathy
COMMON BRAND NAMES
Vytorin
HOW SUPPLIED
Vytorin Oral Tab: 10-10mg, 10-20mg, 10-40mg, 10-80mg
DOSAGE & INDICATIONS
For use as an adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and nonfamilial) hypercholesterolemia or mixed hyperlipoproteinemia AND for reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Oral dosage
Adults
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%). The recommended dosage for patients with homozygous familial hypercholesterolemia is ezetimibe 10 mg/simvastatin 40 mg once daily in the evening. After initiation or titration of doses, lipid levels may be analyzed after 2 or more weeks. Adjust dosage, as needed to achieve the target LDL and lipid goals based on the NCEP guidelines. The usual dosage range for Vytorin is ezetimibe 10 mg/simvastatin 10 mg to Vytorin ezetimibe 10 mg/simvastatin 40 mg PO, given once daily in the evening. NOTE: The ezetimibe 10 mg/simvastatin 80 mg dose should only be used in patients who have taken ezetimibe 10 mg/simvastatin 80 mg chronically (e.g. >= 12 months) without evidence of myopathy. Patients who are taking ezetimibe 10 mg/simvastatin 40 mg and are unable to reach their target LDL-C goal should be switched to an alternative agent and not be titrated to ezetimibe 10 mg/simvastatin 80 mg. Also, Chinese patients taking lipid-modifying doses of niacin-containing products should receive doses lower than 80 mg/day.
Adults taking diltiazem or verapamil
Ezetimibe 10 mg/simvastatin 10 mg PO once daily in the evening. Due to the risk of developing myopathy and/or rhabdomyolysis, do not exceed ezetimibe 10 mg/simvastatin 10 mg daily.
Adults taking amiodarone, amlodipine, or ranolazine
Ezetimibe 10 mg/simvastatin 20 mg PO once daily in the evening. Due to the risk of developing myopathy and/or rhabdomyolysis, do not exceed ezetimibe 10 mg/simvastatin 20 mg daily.
Adults with homozygous familial hypercholesterolemia taking lomitapide
Ezetimibe 10 mg/simvastatin 20 mg PO once daily in the evening. Due to the risk of developing myopathy and/or rhabdomyolysis, do not exceed ezeti |
