Drug monograph for the active ingredient in Vytorin

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

EZETIMIBE AND SIMVASTATIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Vytorin

† Not commercially available in Canada.

Category

• Antihyperlipidemic

Description

Ezetimibe and Simvastatin (e-ZET-e-mibe and SIM-va-stat-in) is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, 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 ezetimibe and simvastatin combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ezetimibe or simvastatin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Ezetimibe and simvastatin should not be used during pregnancy or by women who plan to become pregnant . This medicine blocks formation of cholesterol, which is necessary for the fetus to develop properly. This medicine 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—It is not known if ezetimibe and simvastatin passes into breast milk. However, it should not be used during breast-feeding because it may cause serious unwanted effects in nursing babies.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. This medicine should only be used in children 10 years of age or older.

Older adults—This medicine has been tested 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 ezetimibe and simvastatin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol—May cause liver problems and should not be used while taking ezetimibe and simvastatin.

• Amiodarone (e.g., Cordarone) or
• Verapamil (e.g., Calan)—May increase your risk of serious side effects.

• Cyclosporine (e.g., Sandimmune)—May increase the amount of ezetimibe in your blood.

• Clarithromycin (e.g., Biaxin) or
• Erythromycin (e.g., Erythrocin) or
• Grapefruit juice (large amounts) or
• HIV protease inhibitors (e.g., Reyataz, Viracept) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral). or
• Nefazodone (e.g., Serzone)—May increase your risk of serious side effects.

• Fibric Acid Derivatives, such as
  • Fenofibrate (e.g., Tricor) or
  • Gemfibrozil (e.g., Lopid)—May increase your risk of serious side effects.

• Niacin (nicotinic acid) in lipid-lowering doses—Use of these medicines with ezetimibe and simvastatin may increase the risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

• Warfarin—May increase risk of side effects; prothrombin time should be monitored for changes.

Other medical problems—The presence of other medical problems may affect the use of ezetimibe and simvastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease (or history of) or
• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

• Major surgery or serious illness—May increase chance of kidney side effects

• Complicated medical histories or
• Diabetes mellitus (sugar diabetes) or
• Kidney disease—May increase risk of muscle side effects

Proper Use of This Medicine

Dosing—The dose of ezetimibe will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of ezetimibe. If your dose is different, do not change it unless your doctor tells you to do so.

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine 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 weight-reducing diet. However, check with your doctor before going on any diet.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults—1 tablet a day, tablet strength is determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed dose— If you miss a dose of this medicine, take it as soon as possible. Do not take more than one dose per day.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol. Your doctor can then decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. Certain cholesterol medications may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever, because the medicine's adverse effects on muscle can lead to serious kidney problems.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Abdominal fullness; bloating; chills; constipation; darkened urine; fast heartbeat; fever; gaseous abdominal pain; hives; hoarseness; indigestion; irritation; itching; joint pain; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of appetite; nausea; pains in stomach, side, or abdomen, possibly radiating to the back; severe nausea; stomach pain; rash; recurrent fever; redness of skin; shortness of breath; stiffness; swelling of eyelids, face, lips, hands, or feet; tightness in chest; troubled breathing or swallowing; vomiting; wheezing; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

Less common

Body aches or pain; cough; diarrhea; difficulty in breathing; difficulty in moving; ear congestion; general feeling of discomfort or illness; headache; loss of voice; muscle aches and pains or cramping; muscle stiffness; nasal congestion; pain in arms or legs; runny nose; shivering; sneezing; sore throat; sweating; swollen joints; trouble sleeping; unusual tiredness or weakness; vomiting

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/06/2004

The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

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