Simvastatin 

(sim' va stat in)

WHY is this medicine prescribed?

Simvastatin is used together with diet, weight-loss, and exercise to reduce the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Simvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Simvastatin is also used to decrease the risk of heart attacks, strokes, and death, and to decrease the need for surgery to improve blood flow in people who have medical conditions that put them at high risk of developing heart and blood vessel problems. Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

HOW should this medicine be used?

Simvastatin comes as a tablet to take by mouth. It usually is taken once a day in the evening. Take simvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take simvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of simvastatin and gradually increase your dose, not more than once every 4 weeks.

Continue to take simvastatin even if you feel well. Do not stop taking simvastatin without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking simvastatin,

  • tell your doctor and pharmacist if you are allergic to simvastatin, any other medications, or any of the ingredients in simvastatin tablets. Ask your doctor or pharmacist for a list of the ingredients.
  • tell your doctor if you are taking antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); boceprevir (Victrelis); clarithromycin (Biaxin, in PrevPac); cyclosporine (Gengraf, Neoral, Sandimmune); danazol; erythromycin (E.E.S., E-Mycin, Erythrocin); gemfibrozil (Lopid); HIV protease inhibitors such as atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); nefazodone; telaprevir (Incivek); and telithromycin (Ketek). Your doctor will probably tell you not to take simvastatin if you are taking these medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); amlodipine (Norvasc, in Caduet, in Lotrel); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); colchicine (Colcrys); digoxin (Digitek, Lanoxicaps, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac); other cholesterol-lowering medications such as fenofibrate (Tricor) and niacin (nicotinic acid, Niacor, Niaspan); ranolazine (Ranexa); verapamil (Calan, Covera, Isoptin, Verelan); and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have liver disease. Your doctor will order blood tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably tell you not to take simvastatin if you have liver disease or if the tests show that you may be developing liver disease.
  • tell your doctor if you drink more than two alcoholic beverages per day or if you are Asian, especially if you are Chinese. Also tell your doctor if you have or have ever had an underactive thyroid gland, diabetes, seizures, low blood pressure, or kidney disease.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during your treatment with simvastatin. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking simvastatin, stop taking simvastatin and call your doctor immediately. Simvastatin can harm the fetus.
  • tell your doctor if you are breast-feeding. You should not breast-feed while you are taking simvastatin.
  • you should know that the risk that you will develop serious muscle and kidney problems during your treatment with simvastatin is higher if you are 65 years of age or older. Talk to your doctor about the risks of taking simvastatin.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking simvastatin. If you are hospitalized due to serious injury or infection, tell the doctor who treats you that you are taking simvastatin.
  • ask your doctor about the safe use of alcoholic beverages while you are taking simvastatin. Alcohol can increase the risk of serious side effects.

What SPECIAL DIETARY instructions should I follow?

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf .

Avoid drinking large quantities (more than 1 quart [approximately1 liter] a day) of grapefruit juice while taking simvastatin.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Simvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • constipation
  • stomach pain

• nausea

  • headache
  • memory loss or forgetfulness
  • confusion

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help.

  • muscle pain, tenderness, or weakness
  • dark red urine
  • decreased urination
  • lack of energy, tiredness, or weakness
  • loss of appetite
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • dark colored urine
  • fever or chills
  • flushing
  • blisters

• rash

• hives

• itching

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • difficulty breathing or swallowing
  • hoarseness
  • joint pain
  • sensitivity to light

This medication may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests during your treatment, especially if you develop symptoms of liver damage.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names
  • Zocor®
  • Juvisync® (as a combination product containing Simvastatin, Sitagliptin)
  • Simcor® (as a combination product containing Niacin, Simvastatin)
  • Vytorin® (as a combination product containing Ezetimibe, Simvastatin)
  • Also available generically

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