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What is the most important information I should know about simvastatin?

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take simvastatin if you have liver disease or if you are breast-feeding.

Before taking simvastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, a muscle disorder, or a blood disorder:

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 while taking simvastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking simvastatin.

There are many other drugs that can interact with simvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is simvastatin?

Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Simvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

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


Precautions

Do not use this medication if you are allergic to simvastatin, if you are pregnant or breast-feeding, or if you have liver disease.

Before taking simvastatin, tell your doctor if you are allergic to any drugs, or if you have:

  • diabetes;
  • underactive thyroid;
  • kidney disease; or
  • a muscle disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take simvastatin.

FDA pregnancy category X. This medication can cause birth defects. Do not use simvastatin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

It is not known whether simvastatin passes into breast milk. Do not take simvastatin without telling your doctor if you are breast-feeding a baby.

Simvastatin is not for use in children younger than 10 years of age.

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 while taking simvastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking simvastatin.

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of simvastatin is not expected to produce life-threatening symptoms.

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

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Side-effects

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

Stop using simvastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • mild stomach pain, gas, bloating, stomach upset, heartburn;
  • nausea;
  • constipation; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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Interactions

Many drugs can interact with simvastatin. Below is just a partial list. Tell your doctor if you are using:

  • danazol (Danocrine);
  • gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);
  • niacin (Nicolar, Nicobid, Slo-Niacin, others);
  • nefazodone (Serzone);
  • cholestyramine (Questran) or colestipol (Colestid);
  • a blood thinner such as warfarin (Coumadin); or
  • amiodarone (Cordarone), diltiazem (Cartia, Cardizem, Dilacor, Tiazac), or verapamil (Verelan, Calan, Isoptin);
  • erythromycin (E-Mycin, Ery-Tab, others), clarithromycin (Biaxin), or telithromycin (Ketek);
  • an antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral);
  • drugs that weaken your immune system such as cancer medicine or steroids, cyclosporine (Neoral, Sandimmune, Gengraf), sirolimus (Rapamune), tacrolimus (Prograf), and others;
  • HIV or AIDS medication such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), lopinavir-ritonavir (Kaletra), or saquinavir (Invirase, Fortovase).

This list is not complete and there may be other drugs that can interact with simvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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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 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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