Simvastatin

Pronunciation

Generic Name: simvastatin (SIM-va-STAT-in)
Brand Name: Zocor

Simvastatin is used for:

Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL) ("good") cholesterol levels. It is used along with an appropriate diet. It is used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to reduce the need for medical procedures to open blocked blood vessels. It is also used in certain patients to reduce the risk of heart attack, stroke, blood vessel blockage, or chest pain caused by angina. It may also be used for other conditions as determined by your doctor.

Simvastatin is an HMG-CoA reductase inhibitor, also known as a "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use simvastatin if:

  • you are allergic to any ingredient in simvastatin
  • you have liver problems or unexplained abnormal liver function tests
  • you are pregnant, may become pregnant, or are breast-feeding
  • you take boceprevir, clarithromycin, cobicistat, cyclosporine, danazol, erythromycin, gemfibrozil, an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

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Before using simvastatin:

Some medical conditions may interact with simvastatin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have low blood pressure, kidney problems, diabetes, low thyroid function, muscle problems or a family history of muscle problems, or serious metabolism, hormonal, or electrolyte problems
  • if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse
  • if you are scheduled for major surgery or have recently had major surgery or a serious injury, or if you have a serious infection
  • if you have had an organ transplant and are taking medicine to suppress a rejection reaction

Some MEDICINES MAY INTERACT with simvastatin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), boceprevir, cobicistat, colchicine, cyclosporine, danazol, diltiazem, dronedarone, fibrates (eg, gemfibrozil, clofibrate, fenofibrate), HIV protease inhibitors (eg, ritonavir), lomitapide, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, niacin, ranolazine, telaprevir, telithromycin , or verapamil because they may increase the risk of muscle or kidney problems
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by simvastatin

This may not be a complete list of all interactions that may occur. Ask your health care provider if simvastatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use simvastatin:

Use simvastatin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take simvastatin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
  • Eating grapefruit or drinking grapefruit juice may increase the amount of simvastatin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking simvastatin.
  • Continue to take simvastatin even if you feel well. Do not miss any doses.
  • If you miss a dose of simvastatin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use simvastatin.

Important safety information:

  • Simvastatin may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking simvastatin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with simvastatin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking simvastatin. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • Follow the diet and exercise program given to you by your health care provider.
  • Tell your doctor or dentist that you take simvastatin before you receive any medical or dental care, emergency care, or surgery. Simvastatin may need to be stopped for a few days before certain types of surgery.
  • Women who are able to become pregnant should use effective birth control while taking simvastatin. Check with your doctor if you have questions about using birth control.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Muscle problems (myopathy) may occur with simvastatin. The risk of muscle problems may be greater in people who take higher doses of simvastatin, in people older than 64 years old, in females, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking simvastatin.
  • Diabetes patients - Simvastatin may increase your blood sugar levels. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.
  • Lab tests, including blood cholesterol levels, liver function, and creatine phosphokinase (CPK) blood levels, may be performed while you use simvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use simvastatin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Simvastatin should be used with extreme caution in CHILDREN younger than 10 years old and in those who have not reached puberty; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use simvastatin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if simvastatin is found in breast milk. Do not breast-feed while taking simvastatin.

Possible side effects of simvastatin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; headache; mild stomach pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; confusion; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain; loss of appetite; memory problems; muscle pain, tenderness, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea or stomach or back pain; shortness of breath; trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of simvastatin:

Store simvastatin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep simvastatin out of the reach of children and away from pets.

General information:

  • If you have any questions about simvastatin, please talk with your doctor, pharmacist, or other health care provider.
  • Simvastatin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take simvastatin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about simvastatin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to simvastatin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using simvastatin.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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