Not for use in active liver disease or in patients with high levels of liver function tests.
You should not consume large amounts of alcohol or have a history of liver disease.
Liver function should be monitored before initiation and periodically during therapy.
May require reduced doses in impaired kidney function.
Can also cause severe muscles aches which are a symptom of a more serious disorder (rhabdomyolysis) in which the muscle fibers break down. If this disorder progresses, decreases in kidney function may also occur. This risk is increased with concurrent use of drugs that increase simvastatin levels.
DRUG INTERACTIONS
Azole antifungals, ciprofloxacin, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil. cyclosporine, clofibrate, fenofibrate, gemfibrozil, levothyroxine, digoxin, ethinyl estradiol, cholestyramine, and niacin.
This drug is metabolized by a specific set of liver enzymes (cytochrome P450 enzymes, 3A4). Several other drugs interfere with these liver enzymes, and thus may increase or decrease the clearance of simvastatin from the body, potentially increasing the risk of side effects or decreasing effectiveness.
When these drugs are given in combination with simvastatin, dosage adjustments may be needed. As these are too numerous to list, you should always check with your doctor or pharmacist prior to starting a new medication, herbal, or nonprescription product.
FOOD INTERACTIONS
Grapefruit juice. Avoid excessive intake of alcohol.
HERBAL INTERACTIONS
St. John’s wort
PREGNANCY AND BREAST-FEEDING CAUTIONS
FDA Pregnancy Risk Category X. Simvastatin should not be used during breast-feeding.
SPECIAL INFORMATION
Before initiation of therapy, patients should be placed on a standard cholesterol-lowering diet for six weeks and the diet should be continued during drug therapy. Report any signs of muscle pain, tenderness, or weakness to doctor.
