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ZOCOR
SIMVASTATIN - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

SIMVASTATIN - ORAL

(SIM-vuh-stat-in)

COMMON BRAND NAME(S): Zocor

Uses

Simvastatin is an enzyme blocker (HMG-CoA reductase inhibitor), also known as a "statin". It is used along with a proper diet to help lower cholesterol and fats (triglycerides) in the blood. In general, this drug is prescribed after non-drug treatment options have not been fully successful at lowering cholesterol (e.g., diet change, increase in exercise, weight loss if overweight). Reducing cholesterol and triglycerides help prevent strokes and heart attacks. Simvastatin is used in adults and children (10 years of age and older). Young girls must have had their menstrual periods for at least one year before starting this medication.

How To Use

Take this medication by mouth usually once daily in the evening, with or without food. Certain medical conditions (e.g., familial hypercholesterolemia) may require more frequent dosage instructions as directed by your doctor. Dosage is based on your medical condition, response to therapy, and use of certain interacting medicines. Many of the drugs listed in the Drug Interactions section may increase the chances of muscle injury when used with simvastatin. Consult your doctor or pharmacist for more details. Limit the amount of grapefruit or grapefruit juice you may eat or drink (less than 1 quart a day) while being treated with this medication, unless specifically directed otherwise. Grapefruit juice may increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take simvastatin at least 1 hour before or at least 2 hours after these medications. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take up to 4 weeks before the full benefit of this drug takes effect. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.

Side Effects

Stomach upset may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly. This drug may infrequently cause muscle damage (which can rarely lead to a very serious, possibly fatal, condition called rhabdomyolysis). Stop taking this drug and tell your doctor immediately if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, stomach/abdominal pain, persistent nausea, change in the amount of urine. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), diabetes (poorly controlled), alcohol use, any allergies (especially to other "statins"). The rare development of severe muscle damage (see Side Effects) can infrequently lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially muscle damage. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control measures to prevent pregnancy while taking this drug since simvastatin may cause fetal harm. It is not known if this drug passes into breast milk. Because of the potential risk of undesirable effects on a nursing infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Drug Interactions

See also the How To Use section. This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: certain azole antifungals (e.g., itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (e.g., ritonavir, amprenavir, lopinavir), certain macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin), mibefradil, nefazodone, telithromycin. If you are currently using any of these medications, tell your doctor or pharmacist before starting simvastatin. Use caution if the following drugs are combined with simvastatin because serious side effects such as muscle injury (myopathy) infrequently could occur: fibrates (e.g., gemfibrozil, fenofibrate), high-dose niacin (1 gram or more per day). Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), cholestyramine, colestipol, digoxin, other drugs which affect certain liver enzymes (CYP 3A4 substrates, inhibitors, and inducers such as amiodarone, cyclosporine, diltiazem, verapamil, rifampin, St. John's wort, carbamazepine). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

Do not share this medication with others. Laboratory and/or medical tests (e.g., blood cholesterol levels, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. For best results, this medication should be used along with exercise, a low-cholesterol/low-fat diet, and a weight loss program if you are overweight. Also to help reduce your risk of heart attacks and strokes, check your blood pressure regularly, seek medical treatment if your blood pressure is high, and stop smoking. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store between 41 and 86 degrees F (5 and 30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.