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Drug Notebook

Generic Name: simvastatin

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Zocor
A statin - treats Hyperlipidemia
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FDA Alerts

Special Alerts:

[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of ezetimibe with simvastatin (Vytorin) and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.

FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2 and http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm.

[Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin (Zocor) is used with amiodarone (Cordarone, Pacerone ). This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin, http://www.fda.gov/cder/drug/infopage/simvastatin_amiodarone/default.htm, http://www.fda.gov/cder/drug/InfoSheets/HCP/simvastatin_amiodaroneHCP.htm, http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=simvastatin and http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=amiodarone&x=10&y=11.

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simvastatin
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(SIM va stah tin)

Drug Interactions

Simvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity.

Specific Drugs and Foods

Drug or Food Interaction Comments
Amiodarone

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Increased risk of myopathy and/or rhabdomyolysis, particularly when used with higher dosages of simvastatin

 If used concomitantly, simvastatin dosage should not exceed 20 mg daily
Anticoagulants, oral (e.g., warfarin) Possible increased PT. Bleeding observed with other statins Closely monitor PT until stabilized if simvastatin is initiated or dosage is adjusted in patients receiving a coumarin anticoagulant. Thereafter, monitor PT at intervals usually recommended for patients receiving coumarin anticoagulants
Antileukotrienes (e.g., zileuton) Possible inhibition of CYP3A4 Concomitant use generally should be avoided or undertaken with caution
Azole antifungals (i.e., itraconazole, ketoconazole) Inhibition of CYP3A4-dependent metabolism of simvastatin, resulting in decreased elimination of simvastatin and increased risk of myopathy and/or rhabdomyolysis Concomitant use generally should be avoided. If concomitant use is unavoidable, suspend simvastatin therapy during the course of treatment with antifungal. Avoid concomitant use of simvastatin with other CYP3A4 inhibitors unless benefits of combined therapy outweigh risks
Cyclosporine Inhibition of CYP3A4-dependent metabolism of simvastatin, resulting in decreased elimination of simvastatin and increased risk of myopathy and/or rhabdomyolysis If used concomitantly, initiate simvastatin at 5 mg daily; simvastatin dosage should not exceed 10 mg daily
Danazol Increased risk of myopathy and/or rhabdomyolysis, particularly when used with higher dosages of simvastatin If used concomitantly, initiate simvastatin at 5 mg daily; simvastatin dosage should not exceed 10 mg daily
Digoxin Possible increased plasma digoxin concentrations Monitor patients receiving digoxin when simvastatin is initiated
Diltiazem Possible increased plasma simvastatin concentrations
Fibric acid derivatives

Increased risk of myopathy and/or rhabdomyolysis

Fenofibrate: Pharmacokinetic interaction unlikely

Gemfibrozil: Increased peak plasma concentration and AUC of simvastatin acid

 Use concomitantly with caution. Concomitant use with gemfibrozil generally should be avoided unless benefits of combined therapy outweigh risks; if used concomitantly, simvastatin dosage should not exceed 10 mg daily
Fluvoxamine Possible inhibition of CYP3A4 Concomitant use generally should be avoided or undertaken with caution
Glyburide Possible increased bioavailability of glyburide
Grapefruit juice Inhibition of CYP3A4-dependent metabolism of simvastatin, resulting in decreased elimination of simvastatin and increased risk of myopathy and/or rhabdomyolysis Concomitant use should be discouraged, or simvastatin dosage reduced accordingly; consumption of large quantities (>1 quart daily) of grapefruit juice should be avoided
HIV protease inhibitors Inhibition of CYP3A4-dependent metabolism of simvastatin, resulting in decreased elimination of simvastatin and increased risk of myopathy and/or rhabdomyolysis Concomitant use generally should be avoided unless benefits of combined therapy outweigh increased risk
Macrolide anti-infectives (i.e., clarithromycin, erythromycin) Inhibition of CYP3A4-dependent metabolism of simvastatin, resulting in decreased elimination of simvastatin and increased risk of myopathy and/or rhabdomyolysis Concomitant use generally should be avoided. If concomitant use is unavoidable, suspend simvastatin therapy during the course of treatment with the anti-infective. Avoid concomitant use of simvastatin with other CYP3A4 inhibitors unless benefits of combined therapy outweigh risks
Metronidazole Possible inhibition of CYP3A4 Concomitant use generally should be avoided or undertaken with caution
Nefazodone Inhibition of simvastatin metabolism via CYP3A4, resulting in increased risk of myopathy and/or rhabdomyolysis Concomitant use generally should be avoided
Niacin Increased risk of myopathy and/or rhabdomyolysis Concomitant use with antilipemic dosages (≥1 g daily) of niacin generally should be employed with caution; weigh benefits against risks of concomitant therapy
Telithromycin Inhibition of CYP3A4-dependent metabolism of simvastatin, resulting in decreased elimination of simvastatin and increased risk of myopathy and/or rhabdomyolysis Concomitant use generally should be avoided. If concomitant use is unavoidable, suspend simvastatin therapy during the course of treatment with the anti-infective. Avoid concomitant use of simvastatin with other CYP3A4 inhibitors unless benefits of combined therapy outweigh risks
Troleandomycin Possible inhibition of CYP3A4 Concomitant use generally should be avoided or undertaken with caution
Verapamil Increased plasma simvastatin concentrations. Increased risk of myopathy and/or rhabdomyolysis, particularly when used with higher dosages of simvastatin Concomitant use generally should be avoided; if used concomitantly, simvastatin dosage should not exceed 20 mg daily
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Uses Dosage and Administration Cautions Drug Interactions Pharmacokinetics Stability Actions Advice to Patients Preparations
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Centers
·As a Drug
Angina
Arteriosclerosis
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Coronary Heart Disease (CAD)
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High Cholesterol
Hyperlipidemia
Hyperlipoproteinemia Type III
Hyperlipoproteinemia Type IV
Metabolic Syndrome X
Mixed Hyperlipidemia
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