TABLE OF CONTENTS
Brand Names: Flolipid, Zocor
Primary Use: Antihyperlipidemic Agent, reduces elevated LDL levels
Drug Classes: Antihyperlipidemic Agents, HMG-CoA Reductase Inhibitors (statins), Metabolic Agents
Generic Drug Synonyms and Salts: Simvastatin
Related Drugs: Atorvastatin, Rosuvastatin, Pravastatin Sodium, Lovastatin, Pitavastatin, Ezetimibe; Simvastatin
Schedule: Rx (Prescription required)
FDA Established Pharmacologic Class (EPC): HMG-CoA Reductase Inhibitor
Initial FDA approval date: 12/23/1991
Simvastatin (Flolipid or Zocor) belongs to a class of drugs called statins and is currently the 10th most prescribed drug in America. It is prescribed by a doctor to lower cholesterol in people who have been diagnosed with high cholesterol (high levels of LDL cholesterol in the blood). Doctors diagnose high cholesterol through a simple blood test. Cholesterol (and triglycerides) are fats that are made in your body. While some cholesterol is necessary for the body, too much cholesterol is dangerous to your health. Cholesterol, specifically, is made in the liver. Lowering “bad” cholesterol and triglycerides and raising “good” cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks This drug can also lower the risk for heart attack or stroke in patients with diabetes.
Note: Some research has shown a possible relationship between the use of statins and the risk of diabetes, however, the risk of developing diabetes from the use of statins is very small.
Simvastatin is available under the following different brand names: Flolipid, Zocor.
| Estimated number of prescriptions in the United States (2018) | 48,007,043 |
| Top drug rank for 2021 | #10 |
| Average total drug cost | $31.38 (USD) |
| Average out-of-pocket cost | $5.43 (USD) |
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, ZOCOR1
can be started simultaneously with diet.
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular diseases, ZOCOR is indicated to:
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:
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.
ZOCOR has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).
Simvastatin (Zocor) is available in tablet form in the strengths indicated below.
| Tablet Strength | Identifying Features |
| 10 mg of Zocor | “MSD 735” on one side and plain on the other |
| 20 mg of Zocor | “MSD 740” on one side and plain on the other. |
| 40 mg of Zocor | “MSD 749” on one side and plain on the other |
| 80 mg of Zocor | “543” on one side and “80” on the other |
No. 8146 — Tablets ZOCOR 10 mg are peach, oval, film-coated tablets, coded MSD 735 on one side and plain on the other. They are supplied as follows:
No. 8147 — Tablets ZOCOR 20 mg are tan, oval, film-coated tablets, coded MSD 740 on one side and plain on the other. They are supplied as follows:
No. 8148 — Tablets ZOCOR 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other. They are supplied as follows:
No. 6577 — Tablets ZOCOR 80 mg are brick red, capsule-shaped, film-coated tablets, coded 543 on one side and 80 on the other. They are supplied as follows:
Store at controlled room temperature 20 -25°C (68 -77°F).
The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, ZOCOR can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
Usual dosage range: 5-40 mg orally once/day
Initial: 10-20 mg orally once/day in the evening
Patients at high CHD risk: Start 40 mg/day
Children under 10 years: Safety and efficacy not established
Recommended dose: 40 mg orally once/day in the evening
See limitations for 80 mg/day, listed below
Adolescents aged 10-17 years
5-40 mg PO qDay in the evening
Moderate reduction of LDL-C desired: 5-10 mg PO qDay in the evening; adjust dose to achieve goal
Reduction of >40% of LDL-C desired: 40 mg PO qDay in the evening; adjust dose to achieve goal
Presence of CHD or at high risk for cardiovascular events, including patients with diabetes, PVD, history of stroke or other cerebrovascular disease: 40 mg PO qDay in the evening adjunct to diet therapy (initiate simultaneously); adjust dose to achieve goal
ACC/AHA Cholesterol Guideline Recommendations (2013) for adults ≥21 years
Severe renal impairment (CrCl less than 30 mL/min): 5 mg once/day initially
Co-administration with dronedarone, verapamil, or diltiazem: Do not exceed 10 mg/day
Co-administration with amiodarone, amlodipine, or ranolazine: Do not exceed 20 mg/day
Co-administration with lomitapide: Reduce dose by 50%, and do not exceed 20 mg/day (or 40 mg/day in those previously tolerating 80 mg/day) when initiating lomitapide
People of Chinese descent taking lipid-modifying doses of niacin (i.e., 1 g/day or more): Increased risk of myopathy with 40 mg/day; consider lower dose
People of Asian descent should not receive 80 mg co-administered with lipid-modifying doses of niacin-containing products
Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter
Simvastatin is generally well tolerated. Possible side effects may include any of the following and the side effects experienced may be transitory (clears up after a few days) or may remain. Consult your doctor immediately if you experiencing serious side effects. Note the list below is not exhaustive.
Common side effects of simvastatin include:
Less common side effects of simvastatin include:
Postmarketing side effects of simvastatin reported include:
Adverse reactions associated with Simvastatin therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, and pancreatitis.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use
Do not take Zocor if you are allergic to simvastatin or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Non-serious and reversible cognitive side effects may occur.
Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake.
Heavy alcohol use, history of liver disease, renal failure.
Monitor LFTs before initiating treatment and thereafter when clinically indicated; reports of fatal and nonfatal hepatic failure in people taking statins .
Discontinue if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
Increases in HbA1c and fasting serum glucose levels reported with simvastatin.
Severe electrolyte, endocrine, or metabolic disorders.
Grapefruit juice increases simvastatin systemic exposure; avoid large quantities of grapefruit juice (i.e., 1 quart/day or more).
Simvastatin and myopathy risk:
Your pharmacist will be aware of potential interactions between Simvastatin and any other medications you use. It’s wise to double-check with your pharmacist and always read package inserts and check the drugs you currently use for possible interactions. If in doubt, revert to your pharmacist with a list of all your medication. It’s a great idea if you own a smartphone to add all your medications to an app on your phone. This can be a lifesaver.
This drug has severe interactions with at least 32 different drugs.
This drug has serious interactions with at least 79 different drugs.
This drug has moderate interactions with at least 79 different drugs.
Simvastatin is not indicated for use in pregnant or breastfeeding women.
Contraindicated in women who are or may become pregnant
Lipid lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development
Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy
There are no adequate and well-controlled studies of use with statins during pregnancy; however, there are rare reports of congenital anomalies in infants exposed to statins in utero
Unknown if simvastatin excreted in human milk; because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not breastfeed
A decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother
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