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Drug monograph for the active ingredient in Crestor

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.

ROSUVASTATIN (Systemic)

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Some commonly used brand names are:

In the U.S.�

• Crestor

In Canada�

• Crestor

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Category

• Antihyperlipidemic

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Description

Rosuvastatin (roe-SOO-va-sta-tin) 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.

Rosuvastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood.

Rosuvastatin is available only with your doctor's prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

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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 rosuvastatin, the following should be considered:

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

Pregnancy�Rosuvastatin 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. Rosuvastatin 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 rosuvastatin passes into breast milk. However, it should not be used during breast-feeding because it may cause serious unwanted effects in nursing babies.

Children�Studies on this medicine have been done only in adult patients and a small number of pediatric patients 8 years of age and older, and there is no specific information comparing use of rosuvastatin in children with use in other age groups.

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 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 rosuvastatin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antacid, aluminum and magnesium hydroxide-containing (e.g., Gelusil, Maalox, Mylanta)�Use of this medicine with rosuvastatin may decrease the amount of rosuvastatin in the body. Antacids should be taken at least two hours after rosuvastatin.

• Cyclosporine (e.g., Gengraf, Neoral, Sandimmune)�May increase the risk of serious side effects

• Gemfibrozil (e.g., Lopid)�May increase the risk of serious side effects.

• Warfarin (e.g., Coumadin)�May increase the risk of bleeding.

• Fibrates (Fenofibrate [e.g., Tricor]) or
• Niacin (e.g., Niaspan) or
• Other lipid-lowering drugs�May increase risk of serious side effects

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

• Alcohol abuse (or history of) or
• Liver problems (or history of) or
• Liver enzymes, persistently high levels�Use of this medicine may make liver problems worse.

• Chinese or Japanese ancestry�May increase the amount of rosuvastatin in the body.

• Convulsions (seizures), not well-controlled, or
• Electrolyte or metabolic enzyme deficiencies or disorders or
• Infection, severe or
• Low blood pressure or
• Major surgery or trauma, recent�Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

• Kidney problems or
• Older adult or
• Underactive thyroid�May increase your chance of getting a serious side effect.

• Muscle problems�Use of this medicine may make muscle problems worse.

• Protein in the urine�Rosuvastatin may cause this problem. Your doctor may want to decrease the dose of rosuvastatin if you get this problem.

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Proper Use of This Medicine

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

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.

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.

Dosing�The dose of rosuvastatin 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 rosuvastatin. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking rosuvastatin

• For oral dosage form tablets:
  • Adult: Oral, 5 to 40 mg once daily
  • 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage�To store this medicine:

• Keep out of the reach of children.
• Store at room temperature.
• 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.
• 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.

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Precautions While Using This Medicine

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

Check with your doctor immediately if you think that you may be pregnant. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Do not use excessive amounts of alcohol while taking rosuvastatin because it can worsen the adverse effects of this medicine on the liver.

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.

If your symptoms do not improve or if they become worse, check with your doctor.

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Side Effects of This Medicine

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

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Developed: 02/04/2004
Revised: 03/10/2005

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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