Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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VYTORIN 10mg/10mg |
| Manufacturer |
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Merck/Schering-Plough |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor. |
| Generic Name |
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Ezetimibe 10mg + simvastatin 10mg; tabs. |
| Also |
• VYTORIN 10mg/20mg
• VYTORIN 10mg/40mg
• VYTORIN 10mg/80mg
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| Indications |
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Adjunct to diet in primary hypercholesterolemia (heterozygous familial and non-familial) or mixed hyperlipidemia: to reduce elevated total-C, LDL-C, apo B, TG and non-HDL-C, and to increase HDL-C. Adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia are not available: to reduce elevated total-C and LDL-C. |
| Children |
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Not recommended. |
| Adults |
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Take once daily in the PM. ≥17yrs: Initially 10mg/20mg; for LDL-C reduction >55%: may start at 10mg/40mg; monitor lipids after 2 wks then periodically. Homozygous familial hypercholesterolemia: 10mg/40mg or 10mg/80mg. Concomitant cyclosporine, danazol: max 10mg/10mg. Concomitant amiodarone, verapamil: max 10mg/20mg. Severe renal insufficiency (CrCl≤30mL/min), or concomitant cyclosporine, danazol: avoid unless simvastatin ≥5mg/day tolerated, monitor closely. |
| Contraindications |
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Active liver disease. Unexplained persistant elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Moderate to severe hepatic impairment: not recommended. Monitor liver function at baseline, then as needed; test before increasing dose to 10mg/80mg per day, then after 3 months, and semiannually for 1st year; discontinue if AST or ALT levels of ≥3XULN persist. History of liver disease. Substantial alcohol consumption. Discontinue if myopathy or elevated creatine kinase >10XULN levels occur. Severe renal insufficiency. |
| Interactions |
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Suspend Vytorin if itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin must be used (due to increased risk of myopathy); avoid other potent CYP3A4 inhibitors (eg, HIV protease inhibitors, cyclosporine, nefazodone, grapefruit juice >1 quart daily). Avoid fibrates. Caution with niacin. Separate dosing of bile acid sequestrants (give ≥2hrs before or ≥4hrs after). Monitor digoxin, cyclosporine, oral anticoagulants. Others (see doses). |
| Adverse Reactions |
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Headache, myalgia, pain in extremity, myopathy, rhabdomyolysis, elevated serum transaminases. |
| How Supplied |
Tabs (10mg/10mg, 10mg/20mg)—30, 90, 1000, 10000
10mg/40mg, 10mg/80mg—30, 90, 500 |
| Additional Resources |
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• Related Prescribing Note |
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