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Zocor Simvastatin Prescription Information

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Zocor TabletsThe following information is a summary about Zocor. It is not intended to replace a doctor's instructions.

Zocor USES
Zocor (Simvastatin) is a cholesterol- lowering medicine. It inhibits the production of cholesterol by the liver. It lowers overall blood cholesterol as well as blood LDL cholesterol levels. LDL cholesterol is believed to be the "bad" cholesterol that is primarily responsible for the development of coronary artery disease. Lowering LDL cholesterol levels retards progression and may even reverse coronary artery disease.

Zocor DIRECTIONS
Take your Zocor by mouth as prescribed. May be taken on an empty or full stomach.

Zocor SIDE EFFECTS
Zocor is generally well-tolerated and side effects are rare. Minor side effects include constipation, diarrhea, fatigue, gas, heartburn, and headache. Major side effects include abdominal pain or cramps, blurred vision, dizziness, easy bruising or bleeding, itching, muscle pain or cramps, rash, and yellowing of the skin or eyes.

Zocor PRECAUTIONS
Zocor is generally well- tolerated. The medication should be used with caution in patients with alcohol or other liver diseases. Persistently abnormal liver tests during treatment are rare, but may lead to a discontinuation of the medication. Rare cases of muscle inflammation (myositis) and breakdown have been reported with simvastatin. Muscle breakdown causes the release of muscle protein (myoglobin) into the blood and kidney tubules, resulting in acute kidney failure. The risk of muscle breakdown is increased when simvastatin is given together with other medications such as cyclosporine (Sandimmune), gemfibrozil (Lopid), erythromycin and nicotinic acid. Simvastatin may interact with cholestyramine (Questran), warfarin (Coumadin), and cimetidine (Tagamet) to alter the blood levels of these medicines. When Coumadin is given together with simvastatin, blood clotting times require monitoring to avoid excessive blood thinning and bleeding. Simvastatin should not be used in children. Simvastatin is not habit forming.

Zocor DRUG INTERACTIONS
Tell your doctor of all prescription and nonprescription meds you may use, especially of: carbamazepine, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, antidepressants (e.g., SSRI-types such as fluoxetine or fluvoxamine), MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, procarbazine, selegiline, tranylcypromine), psychiatric medicine (e.g., nefazodone), "triptan"-type drugs, anti-anxiety drugs (e.g., diazepam), sibutramine. Also, report use of certain antihistamines (e.g., diphenhydramine) which are also present in many cough-and-cold products. Do not start or stop any medicine without doctor or pharmacist approval.

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

Zocor NOTES
Atorvastatin, cerivastatin #, fluvastatin, lovastatin, pravastatin, and simvastatin are used to lower levels of cholesterol and other fats in the blood. This may help prevent medical problems caused by cholesterol clogging the blood vessels. These medicines belong to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. They work by blocking an enzyme that is needed by the body to make cholesterol. Thus, less cholesterol is made. HMG-CoA reductase inhibitors are available only with your doctor's prescription, in the following dosage forms: * Oral Atorvastatin o Tablets (U.S. and Canada) * Cerivastatin o Tablets # * Fluvastatin o Capsules (U.S. and Canada) * Lovastatin o Extended-Release Tablets (U.S.) o Tablets (U.S. and Canada) * Pravastatin o Tablets (U.S. and Canada) * Simvastatin o Tablets (U.S. and Canada) Before Using This Medicine In deciding to use Zocor, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For HMG-CoA reductase inhibitors, the following should be considered: Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to HMG-CoA reductase inhibitors. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Diet-Before prescribing medicines to lower your cholesterol, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet will be lower in total fat, particularly saturated fat, and dietary cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Zocor is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed. Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet. Pregnancy-HMG-CoA reductase inhibitors should not be used during pregnancy or by women who plan to become pregnant in the near future. Zocor and similar medicines block formation of cholesterol, which is necessary for the fetus to develop properly. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy. An effective form of birth control should be used during treatment with these medicines. Check with your doctor immediately if you think you have become pregnant while taking this medicine. Be sure you have discussed this with your doctor. Breast-feeding-Zocor is not recommended for use during breast-feeding because they may cause unwanted effects in nursing babies. Children-Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of HMG-CoA reductase inhibitors in children with use in other age groups. However, atorvastatin, lovastatin, and simvastatin have been used in a limited number of children under 18 years of age. Early information seems to show that these medicines may be effective in children, but their long-term safety has not been studied. Older adults-This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. Other medicines-Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking HMG-CoA reductase inhibitors such as Zocor, it is especially important that your health care professional know if you are taking any of the following: * Cyclosporine (e.g., Sandimmune) or * Gemfibrozil (e.g., Lopid) or * Clofibrate (e.g., Atromid-S) or * Fenofibrate (e.g., Tricor) or * Niacin-Use of these medicines with an HMG-CoA reductase inhibitor may increase the risk of developing muscle problems and kidney failure * Digoxin (e.g., Lanoxin)-Use with atorvastatin, fluvastatin, or simvastatin may increase blood levels of digoxin, increasing the risk of side effects * Oral contraceptives, (birth control tablets)-Atorvastatin may increase the blood levels of the birth control hormones, increasing the risk of side effects * HIV protease inhibitors (Amprenavir [e.g., Agenerase], Indinavir [e.g., Crixivan], Nelfinavir [e.g., Viracept], Ritonavir [e.g., Norvir], Saquinavir [e.g., Fortovase, Invirase]) or * Nefazodone (e.g. Serzone)-Use with simvastatin may increase the risk of developing muscle problems and kidney failure * Verapamil (e.g. Calan, Isoptin)-Use with simvastatin may increase the risk of muscle problems Other medical problems-The presence of other medical problems may affect the use of HMG-CoA reductase inhibitors. Make sure you tell your doctor if you have any other medical problems, especially: * Alcohol abuse (or history of) or * Liver disease-Use of Zocor may make liver problems worse * Convulsions (seizures), not well-controlled, or * Organ transplant with therapy to prevent transplant rejection or * If you have recently had major surgery-Patients with these conditions may be at risk of developing problems that may lead to kidney failure

MISSED DOSE
If you miss a dose, use Zocor 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-up" the dose to catch up.

Zocor STORAGE
Store Zocor at room temperature between 36 and 77 degrees F (2 -25 degrees C) away from light and moisture.


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