Simvastatin

Pronunciation

Generic Name: simvastatin (SIM va sta tin)
Brand Names: Zocor

What is simvastatin?

Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." It reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Simvastatin is used to lower cholesterol and triglycerides (types of fat) in the blood.

Simvastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors

This medicine is used in adults and children who are at least 10 years old.

Simvastatin may also be used for purposes not listed in this medication guide.

Important information

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Never take simvastatin in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

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Many other drugs can interact with simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Before taking simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

Simvastatin can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not consume grapefruit products while taking this medication.

Before taking this medicine

You should not take simvastatin if you are allergic to it, if you have liver disease, or if you are pregnant or breast-feeding.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid). You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose simvastatin while also taking medication that contains niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

Some medicines can cause unwanted or dangerous effects when used with simvastatin. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cyclosporine;

  • danazol;

  • gemfibrozil;

  • nefazodone;

  • the antibiotics clarithromycin, erythromycin, and telithromycin;

  • the antifungal medications itraconazole, ketoconazole, and posaconazole;

  • the hepatitis C medications boceprevir and telaprevir; or

  • the HIV/AIDS medications atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, and tipranavir.

Before you start taking simvastatin, tell your doctor if you are already using any of these other medicines:

  • amiodarone;

  • diltiazem;

  • amlodipine;

  • ranolazine; or

  • verapamil.

To make sure simvastatin is safe for you, tell your doctor if you have:

  • history of liver disease;

  • history of kidney disease;

  • diabetes;

  • a thyroid disorder; or

  • if you drink more than 2 alcoholic beverages daily.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking simvastatin.

See also: Pregnancy and breastfeeding warnings (in more detail)

Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking this medicine.

How should I take simvastatin?

Take simvastatin exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Taking too much of this medication may cause serious or life-threatening side effects.

Simvastatin is usually taken at bedtime or with an evening meal. If you take simvastatin more than once daily, take it with meals. Your doctor may occasionally change your dose to make sure you get the best results.

While using simvastatin, you may need frequent blood tests at your doctor's office.

You may need to take simvastatin on a long-term basis for the treatment of high cholesterol. You may need to stop using this medicine for a short time if you have surgery or a medical emergency. Do not stop taking this medication unless your doctor tells you to.

Simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not consume grapefruit products while taking this medication.

Avoid eating foods that are high in fat or cholesterol. Simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Simvastatin side effects

Get emergency medical help if you have any of these signs of an allergic reaction to simvastatin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using simvastatin and call your doctor at once if you have:

  • unexplained muscle pain, tenderness, or weakness;

  • confusion, memory problems;

  • fever, unusual tiredness, and dark colored urine;

  • pain or burning when you urinate;

  • swelling, weight gain, little or no urinating;

  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious simvastatin side effects may include:

  • headache;

  • joint pain, mild muscle pain;

  • constipation, stomach pain or indigestion, mild nausea;

  • mild skin rash;

  • sleep problems (insomnia); or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Simvastatin dosing information

Usual Adult Dose of Simvastatin for Hyperlipidemia:

Initial dose: 10 to 20 mg orally once a day in the evening.
Maintenance dose: 5 to 40 mg orally 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 is 40 mg orally once a day.

Usual Adult Dose for Cardiovascular Risk Reduction:

Initial dose: 10 to 20 mg orally once a day in the evening.
Maintenance dose: 5 to 40 mg orally 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 is 40 mg orally once a day.

Usual Adult Dose of Simvastatin for Homozygous Familial Hypercholesterolemia:

Children and Adolescents:

Heterozygous familial hypercholesterolemia:
Adolescents 10 to 17 years: 10 mg once daily in the evening
May increase dose in intervals of 4 weeks or more to a maximum of 40 mg/day

Hyperlipidemia: Limited data in 32 children (less than 17 years of age) enrolled in compassionate use study:
Children less than 10 years: 5 mg once daily in the evening increasing to 10 mg once daily after 4 weeks and to 20 mg once daily after 8 weeks as tolerated.
Children greater than or equal to 10 years: 10 mg once daily in the evening increasing to 20 mg once daily after 6 weeks and to 40 mg once daily after 12 weeks as tolerated.

Note: A lower, conservative dosing regimen may be necessary in patient populations predisposed to myopathy including patients of Chinese descent or those concurrently receiving other lipid-lowering agents (e.g., niacin, fibric acid derivatives), amiodarone, amlodipine, ranolazine, or verapamil.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

10 to 17 years:
Initial dose: 10 mg orally once a day in the evening.
Maintenance dose: 10 to 40 mg/day (the maximum recommended dose is 40 mg/day). Dosage increases should be done at intervals of 4 weeks or more.

What other drugs will affect simvastatin?

Many drugs can interact with simvastatin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with simvastatin, especially:

  • colchicine;

  • digoxin, digitalis;

  • a blood thinner such as warfarin, Coumadin;

  • fenofibric acid or fenofibrate;

  • antifungal medications such as fluconazole or voriconazole;

  • other medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  • drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as sirolimus or tacrolimus; or

  • any other "statin" medication such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or other medication that contains simvastatin (Simcor, Vytorin).

This list is not complete and many other drugs can interact with simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about simvastatin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use simvastatin only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 15.03. Revision Date: 2013-01-11, 12:13:45 PM.

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