Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor: Jay W. Marks, MD
GENERIC NAME: ezetimibe/simvastatin
BRAND NAME: Vytorin
DRUG CLASS AND MECHANISM: Vytorin is a combination of ezetimibe
(Zetia) and simvastatin (Zocor) 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. The ezetimibe component of Vytorin
lowers blood cholesterol by blocking the absorption of cholesterol, including
dietary cholesterol, from the intestine. It does not affect the absorption of
triglycerides. The simvastatin component of Vytorin belongs to a class of drugs
called HMG-CoA reductase inhibitors, commonly called "statins." Statins reduce
cholesterol by blocking an enzyme in the liver (HMG-CoA reductase) that produces
cholesterol. Statins lower total and LDL cholesterol in the blood as well as
triglycerides. They also increase HDL cholesterol.
LDL cholesterol is believed to be an important cause of coronary artery
disease. Lowering LDL cholesterol levels slows and may even reverse coronary
artery disease. Raising HDL cholesterol levels also may slow coronary artery
disease. The FDA approved Vytorin in July 2004.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Tablets of 10/10, 10/20, 10/40, and 10/80 mg
(ezetimibe/simvastatin)
STORAGE: Vytorin should be stored at room temperature, 20°-25°C (68°-77°F).
PRESCRIBED FOR: Vytorin is used for reducing total cholesterol, LDL
cholesterol and triglycerides, and increasing HDL cholesterol.
DOSING: The recommended dose range of Vytorin is 10/10 mg to 10/80 mg,
and it is administered once daily in the evening with or with out food. Therapy
is usually initiated with 10/20 mg daily, but individuals who need more than a 55%
reduction in LDL cholesterol can be started on 10/40 mg daily.
DRUG INTERACTIONS: Vytorin contains simvastatin (Zocor), and numerous drugs block the
elimination of simvastatin by the liver. Decreased elimination of simvastatin
could increase the levels of simvastatin in the body and increase the risk of
muscle toxicity from simvastatin. Vytorin should not be combined with drugs that
decrease its elimination. Examples of these drugs include
erythromycin
(E-Mycin), ketoconazole (Nizoral), itraconazole (Sporanox), clarithromycin
(Biaxin), telithromycin (Ketek),
cyclosporine (Sandimmune), nefazodone
(Serzone), and HIV protease inhibitors such as indinavir (Crixivan) and
ritonavir (Norvir). Large quantities of grape fruit juice (>1 quart daily) also
will increase blood levels of simvastatin.
Amiodarone (Cordarone), verapamil (Calan Verelan, Isoptin),
danazol (Danocrine),
cyclosporine (Gengraf,
Neoral), niacin (Niacor, Niaspan, Slo-Niacin), gemfibrozil (Lopid) and
fenofibrate (Tricor) also may increase the risk of muscle toxicity when combined
with simvastatin. Patients taking amiodarone or verapamil should not exceed
10/20 mg of Vytorin. Patients taking danazol or cyclosporine should not exceed
10/10 mg of Vytorin.
Simvastatin increases the effect of warfarin (Coumadin) and the blood
concentration of digoxin (Lanoxin). Patients taking simvastatin and warfarin or
digoxin should be monitored carefully.
Cholestyramine (Questran) decreases the absorption of ezetimibe (Zetia). Administer Vytorin 2
hours before or at least 4 hours after cholestyramine administration.
PREGNANCY: Vytorin should not be taken during
pregnancy because the
developing fetus requires cholesterol for development and Vytorin, due to the
simvastatin component, reduces the production of cholesterol. Vytorin should
only be administered to women of child bearing age if they are not likely to
become pregnant.
NURSING MOTHERS: Because of the risk of adverse effects to the developing
infant, Vytorin should not be administered to
nursing mothers.
SIDE EFFECTS: The most common side effects of Vytorin are headache, nausea,
vomiting, diarrhea, muscle pain, and
abnormal liver tests. Hypersensitivity
reactions have also been reported. The most serious potential side effects are
liver damage and muscle inflammation or breakdown.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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