Zocor
Active Ingredients: Simvastatin
Representative Names: Zocor
Available Product Images:

What are simvastatin tablets?
What should my health care professional know before I take simvastatin?
How should I take this medicine?
What if I miss a dose?
What drug(s) may interact with simvastatin?
What side effects may I notice from taking simvastatin?
What should I watch for while taking simvastatin?
Where can I keep my medicine?

What are simvastatin tablets? (Back to top)
SIMVASTATIN (Zocor®) blocks the body's ability to make cholesterol. Simvastatin can help lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet. Generic simvastatin tablets are not yet available.

What should my health care professional know before I take simvastatin? (Back to top)
They need to know if you have any of these conditions:
• an alcohol problem
• any hormone disorder (such as diabetes, under-active thyroid)
• blood salt imbalance
• infection
• kidney disease
• liver disease
• low blood pressure
• muscle disorder or condition
• recent surgery
• seizures (convulsions)
• severe injury
• an unusual or allergic reaction to simvastatin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

TABLETS ZOCOR® (SIMVASTATIN)

DESCRIPTION
ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding b-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.

Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1a,3a,7b,8b(2S*,4S*),-8ab]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57.

Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.

Tablets ZOCOR for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxides, lactose, magnesium stearate, starch, talc, titanium dioxide and other ingredients. Butylated hydroxyanisole is added as a preservative.

How should I take this medicine? (Back to top)
Take simvastatin tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If you take the tablets once a day, it is best to take your dose in the evening hours (like with the evening meal) or at bedtime. You may take this medicine with or without food. Do not take simvastatin with grapefruit juice; orange juice may be used instead. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose? (Back to top)
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with simvastatin? (Back to top)
Do not take Simvastatin with any of the following:
• amprenavir
• atazanavir
• clarithromycin
• delavirdine
• erythromycin
• grapefruit juice
• indinavir
• itraconazole
• ketoconazole
• lopinavir; ritonavir
• mibefradil
• nefazodone
• nelfinavir
• ritonavir
• saquinavir
• went yeast

Simvastatin may also interact with the following medications:
• alcohol
• amiodarone
• barbiturates (examples: phenobarbital, butalbital, primidone)
• bosentan
• carbamazepine
• cyclosporine
• digoxin
• diltiazem
• efavirenz
• fluconazole
• medicines to lower cholesterol or triglycerides (examples: fenofibrate, gemfibrozil, niacin)
• medicine used to stop early pregnancy (mifepristone, RU-486)
• nicardipine
• oxcarbazepine
• phenytoin
• rifampin, rifabutin, or rifapentine
• St. John's Wort
• telithromycin
• troleandomycin
• verapamil
• voriconazole
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking simvastatin? (Back to top)
Side effects that you should report to your prescriber or health care professional as soon as possible:
Rare or uncommon:
• dark yellow or brown urine
• decreased urination, difficulty passing urine
• fever
• muscle pain, tenderness, cramps, or weakness
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• skin rash, itching
• unusual tiredness or weakness
• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• constipation
• headache
• upset stomach, indigestion, gas, heartburn

Uses of Zocor
ZOCOR is a prescription drug that is indicated as an addition to diet for many patients with high cholesterol when diet and exercise are inadequate. For patients with coronary heart disease (CHD) and high cholesterol, ZOCOR is indicated as an addition to diet to reduce the risk of death by reducing coronary death; to reduce the risk of heart attack; to reduce the risk for undergoing cardiac procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty); and to reduce the risk of stroke or transient ischemic attack (TIA).

When Zocor should not be used
Some people should not take ZOCOR. Discuss this with your doctor.

ZOCOR should not be used by patients who are allergic to any of its ingredients. In addition to the active ingredient simvastatin, each tablet contains the following inactive ingredients: cellulose, lactose, magnesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylated hydroxyanisole is added as a preservative.

Patients with liver problems: ZOCOR should not be used by patients with active liver disease or repeated blood test results indicating possible liver problems. (See WARNINGS.)

Women who are or may become pregnant: Pregnant women should not take ZOCOR because it may harm the fetus. Women of childbearing age should not take ZOCOR unless it is highly unlikely that they will become pregnant. If a woman does become pregnant while on ZOCOR, she should stop taking the drug and talk to her doctor at once.

Women who are breast-feeding should not take ZOCOR.

Patients who are also taking the prescription drug Posicor (mibefradil) should not take ZOCOR.

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Warnings
Liver: About 1% of patients who took ZOCOR in clinical trials developed elevated levels of some liver enzymes. Patients who had these increases usually had no symptoms. Elevated liver enzymes usually returned to normal levels when therapy with ZOCOR was stopped.

In the ZOCOR Survival Study, the number of patients with more than one liver enzyme level elevation to greater than 3 times the normal upper limit was no different between the ZOCOR and placebo groups. Only 8 patients on ZOCOR and 5 on placebo discontinued therapy due to elevated liver enzyme levels. Patients were started on 20 mg of ZOCOR, and one third had their dose raised to 40 mg.

Your doctor should perform routine blood tests to check these enzymes before you start treatment with ZOCOR and periodically thereafter (for example, semiannually) for your first year of treatment or until one year after your last elevation in dose. If your enzyme levels increase, your doctor should order more frequent tests. If your liver enzyme levels remain unusually high, your doctor should discontinue your medication.

Tell your doctor about any liver disease you may have had in the past and about how much alcohol you consume. ZOCOR should be used with caution in patients who consume large amounts of alcohol.

Muscle: Tell your doctor right away if you experience any muscle pain, tenderness, or weakness at any time during treatment with ZOCOR, particularly if you have a fever or if you are generally not feeling well, so your doctor can decide if ZOCOR should be stopped. Some patients may have muscle pain or weakness while taking ZOCOR. Rarely, this can include muscle breakdown resulting in kidney damage. The risk of muscle breakdown is greater in patients taking certain other drugs along with ZOCOR, such as the lipid-lowering drug Lopid (gemfibrozil), a fibrate; lipid-lowering doses of nicotinic acid (niacin); the antibiotics erythromycin and clarithromycin; nefazodone; antifungal drugs that are azole derivatives, such as itraconazole and ketoconazole; the calcium channel blocker Posicor; or drugs that suppress the immune system (called immunosuppressive drugs, such as Sandimmune [cyclosporine]). Therapy with ZOCOR should be temporarily interrupted if you are going to take an azole derivative antifungal medication, such as itraconazole. Patients using ZOCOR along with any of these other drugs should be carefully monitored by their physician. The risk of muscle breakdown is greater in patients with kidney problems or diabetes.

If you have conditions that can increase your risk of muscle breakdown, which in turn can cause kidney damage, your doctor should temporarily withhold or stop ZOCOR. Such conditions include severe infection, low blood pressure, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures. Also, since there are no known adverse consequences of briefly stopping therapy with ZOCOR, treatment should be stopped a few days before elective major surgery. Discuss this with your doctor, who can explain these conditions to you.

Because there are risks in combining therapy with ZOCOR with lipid-lowering doses of nicotinic acid (niacin) or with drugs that suppress the immune system, your doctor should carefully weigh the potential benefits and risks. He or she should also carefully monitor patients for any muscle pain, tenderness, or weakness, particularly during the initial months of therapy and if the dose of either drug is increased. Your doctor may also monitor the level of certain muscle enzymes in your body, but there is no assurance that such monitoring will prevent the occurrence of severe muscle disease.

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