ZOCOR SIMVASTATIN

Get an overview of ZOCOR (simvastatin tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in ZOCOR can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as ZOCOR.

Drug Basics

Brand Name: ZOCOR

Generic Name: SIMVASTATIN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2018-10-05

indications & usage

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, ZOCOR® can be started simultaneously with diet.

reductions in risk of chd mortality & cardiovascular events

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, ZOCOR is indicated to:

  • Reduce the risk of total mortality by reducing CHD deaths.
  • Reduce the risk of non-fatal myocardial infarction and stroke.
  • Reduce the need for coronary and non-coronary revascularization procedures.

hyperlipidemia

ZOCOR is indicated to:

  • Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
  • Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
  • Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

adolescent patients with heterozygous familial hypercholesterolemia (hefh)

ZOCOR is indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:

  • LDL cholesterol remains ≥190 mg/dL; or
  • LDL cholesterol remains ≥160 mg/dL and
  • There is a positive family history of premature cardiovascular disease (CVD) or
  • Two or more other CVD risk factors are present in the adolescent patient.

The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.

limitations of use

ZOCOR has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

patient counseling information

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with simvastatin [see Contraindications (4) and Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking ZOCOR.

muscle pain

All patients starting therapy with ZOCOR should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing ZOCOR. Patients using the 80-mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with use of the 80-mg dose. The risk of myopathy, including rhabdomyolysis, occurring with use of ZOCOR is increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

liver enzymes

It is recommended that liver function tests be performed before the initiation of ZOCOR, and thereafter when clinically indicated. All patients treated with ZOCOR should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using ZOCOR. Discuss future pregnancy plans with your patients, and discuss when to stop taking ZOCOR if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking ZOCOR and call their healthcare professional.

breastfeeding

Women who are breastfeeding should not use ZOCOR. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

By:
MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU

For patent information: www.merck.com/product/patent/home.html

Copyright © 1999-2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0733-t-1802r066

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label

NDC 0006-0726-31

Zocor®
(Simvastatin) Tablets

5 mg

Each tablet contains 5 mg of simvastatin.

Rx only

30 Tablets

zocor 03.jpg

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 0006-0735-31

Zocor®
(Simvastatin) Tablets

10 mg

Each tablet contains 10 mg of simvastatin.

Rx only

30 Tablets

zocor 04.jpg

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

NDC 0006-0740-31

Zocor®
(Simvastatin) Tablets

20 mg

Each tablet contains 20 mg of simvastatin.

Rx only

30 Tablets

zocor 05.jpg

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

NDC 0006-0749-31

Zocor®
(Simvastatin) Tablets

40 mg

Each tablet contains 40 mg of simvastatin.

Rx only

30 Tablets

zocor 06.jpg

PRINCIPAL DISPLAY PANEL - 80 mg Tablet Bottle Label

NDC 0006-0543-31

Zocor®
(Simvastatin) Tablets

80 mg

Each tablet contains 80 mg of simvastatin.

Rx only

30 Tablets

zocor 07.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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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