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Vytorin Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
Mechanism of Action
Vytorin Indications
Indications
Adjunct to diet to reduce LDL-C: in adults with primary hyperlipidemia; in adults and pediatric patients with heterozygous familial hypercholesterolemia (HeFH). Adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin, when used as a component of Vytorin: see full labeling.
Vytorin Dosage and Administration
Adults and Children
<10yrs with HeFH, or other types of hyperlipidemia: not established. Take once daily in the PM. ≥10yrs: usually 10mg/10mg to 10mg/40mg daily; max: 10mg/40mg once daily. Restrict 10mg/80mg daily dose to adults who are taking chronically (≥12mos) without evidence of muscle toxicity. For patients that require a high-intensity statin or unable to achieve their LDL-C goal while using Vytorin 10/40mg daily: switch to alternative LDL-C lowering therapy. Moderate to severe renal impairment: max 10mg/20mg daily; caution and monitor closely. Concomitant lomitapide: reduce Vytorin dose by 50%; max 10mg/20mg daily (or 10mg/40mg daily for those previously taken 10mg/80mg daily chronically). Concomitant verapamil, diltiazem, dronedarone: max 10mg/10mg daily. Concomitant amiodarone, amlodipine, ranolazine: max 10mg/20mg daily. Concomitant bile acid sequestrants: give Vytorin either ≥2hrs before or ≥4hrs after bile acid sequestrant administration.
Vytorin Contraindications
Contraindications
Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, nelfinavir, ritonavir, darunavir/ritonavir, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing agents), gemfibrozil, cyclosporine, danazol. Active liver failure or decompensated cirrhosis.
Vytorin Boxed Warnings
Not Applicable
Vytorin Warnings/Precautions
Warnings/Precautions
Increased risk of myopathy/rhabdomyolysis with simvastatin 80mg doses including predisposing factors (eg, age ≥65yrs, female gender, uncontrolled hypothyroidism, renal impairment). Discontinue if markedly elevated CPK (>10×ULN) levels occur or myopathy diagnosed or suspected. Temporarily withhold if acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis occurs. Discontinue if immune-mediated necrotizing myopathy is suspected. Monitor liver function tests prior to initiation and repeat as clinically indicated. Discontinue promptly if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. History of liver disease. Substantial alcohol consumption. Moderate to severe renal impairment. Chinese patients (may be at higher risk for myopathy): monitor. Elderly. Pregnancy: discontinue therapy if occurs. Nursing mothers: not recommended.
Vytorin Pharmacokinetics
See Literature
Vytorin Interactions
Interactions
See Contraindications, Adults and Children. Avoid concomitant grapefruit juice. Caution with fenofibrates, lomitapide (in HoFH patients), colchicine, amiodarone, dronedarone, verapamil, diltiazem, amlodipine, or ranolazine. Antagonized by cholestyramine. Concomitant lipid-modifying doses (≥1g/day) of niacin: not recommended in Chinese patients. Increased risk of rhabdomyolysis with concomitant daptomycin: suspend Vytorin temporarily. Monitor digoxin, coumarin anticoagulants.
Vytorin Adverse Reactions
Adverse Reactions
Vytorin Clinical Trials
See Literature
Vytorin Note
Not Applicable
Vytorin Patient Counseling
See Literature
