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.

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

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.

Before taking this medicine, 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.

Some medicines can cause unwanted or dangerous effects when used with simvastatin. Your doctor may need to change your treatment plan if you use certain antibiotics or antifungal medicines, hepatitis C medication, heart medication, or medicines to treat HIV/AIDS.

Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking this medicine

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

The following drugs can increase your risk of serious muscle problems if you take them together with simvastatin. These drugs should not be used while you are taking this medicine:

• cyclosporine;

• danazol;

• gemfibrozil;

• nefazodone;

• an antibiotic--clarithromycin, erythromycin, telithromycin;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• hepatitis C medications--boceprevir, telaprevir; or

• HIV/AIDS medication--atazanavir, cobicistat (Stribild, Tybost), darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

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

• lomitapide; or

• heart medication--amiodarone, amlodipine, diltiazem, dronedarone, ranolazine, 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.

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).

FDA pregnancy category X. This medicine 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 this medicine.

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 medicine 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 while taking simvastatin?

Grapefruit and grapefruit juice may interact with simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

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.

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.

Also call your doctor at once if you have:

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

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

Common simvastatin side effects may include:

• headache;

• constipation, nausea, stomach pain; 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 for Prevention of Cardiovascular Disease:

Usual dosage range: 5 to 40 mg orally once a day in the evening

Patients with CHD or at high risk of CHD:
Initial dose: 10 to 20 mg orally once a day in the evening started simultaneously with diet and exercise

Patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vascular disease, history of stroke or other cerebrovascular disease:
Initial dose: 40 mg orally once a day in the evening

Comments:
-Therapy should be individualized according to patient response.
-Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
-Due to the increased risk of myopathy (including rhabdomyolysis), particularly during the first year of treatment, use of the 80 mg dose should be restricted to patients who have been taking 80 mg for 12 months or more without evidence of muscle toxicity.

Usual Adult Dose for Cardiovascular Risk Reduction:

Usual dosage range: 5 to 40 mg orally once a day in the evening

Patients with CHD or at high risk of CHD:
Initial dose: 10 to 20 mg orally once a day in the evening started simultaneously with diet and exercise

Patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vascular disease, history of stroke or other cerebrovascular disease:
Initial dose: 40 mg orally once a day in the evening

Comments:
-Therapy should be individualized according to patient response.
-Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
-Due to the increased risk of myopathy (including rhabdomyolysis), particularly during the first year of treatment, use of the 80 mg dose should be restricted to patients who have been taking 80 mg for 12 months or more without evidence of muscle toxicity.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Recommended dose: 40 mg orally once a day in the evening

Comments:
-Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

Less than 10 years: Not recommended

10 years or older:
Initial dose: 10 mg orally once a day in the evening
Maintenance dose: 10 to 40 mg orally once a day in the evening
Maximum dose: 40 mg orally once a day in the evening

Comments:
-Doses should be individualized according to the goal of therapy.
-Dose adjustments should be made at intervals of 4 weeks or more.
-Prior to treatment initiation patients should be placed on a standard cholesterol lowering diet, which should continue during treatment.

Approved indication:
-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 postmenarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
1. LDL cholesterol remains 190 mg/dL or greater; or
2. LDL cholesterol remains 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors are present in the adolescent patient. The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C less than 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.

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, especially:

• delavirdine;

• fenofibrate; or

• fluconazole.

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.