mibe 10 mg/simvastatin 20 mg daily. In patients who have been taking simvastatin 80 mg PO chronically without evidence of muscle toxicity, do not exceed ezetimibe 10 mg/simvastatin 40 mg daily when taking lomitapide.
Children >= 10 years and Adolescents (males and postmenarchal females only)
Usual starting dose is ezetimibe 10 mg/simvastatin 10 mg or ezetimibe 10 mg/simvastatin 20 mg PO once daily in the evening (Max: ezetimibe 10 mg/simvastatin 40 mg). In a multicenter, double-blind, controlled study followed by an open-label phase, 142 males and 106 postmenarchal females aged 10—17 years were randomized to receive either ezetimibe 10 mg/simvastatin (10 mg, 20 mg, or 40 mg) or simvastatin alone (10 mg, 20 mg, or 40 mg) for 6 weeks, then ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg monotherapy for the next 27 weeks. After this time, patients received open-label ezetimibe coadministered with simvastatin (10 mg, 20 mg, or 40 mg) for 20 more weeks. Total cholesterol, LDL, Apo B, Non-HDL cholesterol, and triglycerides were all reduced more in the ezetimibe plus simvastatin group compared to the simvastatin monotherapy group. There was no effect on growth or sexual maturation in the males or females and no effect on menstrual cycle length in the females in this study.
MAXIMUM DOSAGE
Adults
10 mg/day PO ezetimibe and 40 mg/day PO simvastatin for most patients; 80 mg/day PO simvastatin for patients already taking 80 mg/day chronically without evidence of myopathy.
Geriatric
10 mg/day PO ezetimibe and 40 mg/day PO simvastatin for most patients; 80 mg/day PO simvastatin for patients already taking 80 mg/day chronically without evidence of myopathy.
Adolescents
10 mg/day PO ezetimibe and 40 mg/day PO simvastatin.
Children
>= 10 years: 10 mg/day PO ezetimibe and 40 mg/day PO simvastatin.
< 10 years: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Hepatic Impairment
Ezetimibe; simvastatin is contraindicated in patients with active hepatic disease or unexplained persistent elevations in hepatic transaminases.
Renal Impairment
CrCl >= 60 mL/min: No dosage adjustment necessary.
CrCl < 60 mL/min and chronic kidney disease: 10 mg/day PO ezetimibe and 20 mg/day PO simvastatin; higher doses should be used with caution and close monitoring.
ADMINISTRATION
Oral Administration
Administer ezetimibe; simvastatin as a single daily dose in the evening, with or without food.
Dosing should occur either >= 2 hours before or >= 4 hours after administration of an interacting bile acid sequestrant.
STORAGE
Vytorin:
- Store at controlled room temperature (between 68 and 77 degrees F)
CONTRAINDICATIONS / PRECAUTIONS
General Information
NOTE: This monograph discusses the use of the ezetimibe and simvastatin together. Consult individual drug monographs for more detailed information.
Alcoholism, cholestasis, hepatic disease, hepatic encephalopathy, hepatitis, jaundice
Ezetimibe; simvastatin is contraindicated in patients with active hepatic disease including cholestasis, hepatic encephalopathy, hepatitis, jaundice or unexplained persistent elevations in serum aminotransferase concentrations. In addition, patients should minimize alcohol intake while receiving ezetimibe; simvastatin therapy, and ezetimibe; simvastatin should be avoided in patients with alcoholism. Assess liver enzymes prior to initiati |
