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Rosuvastatin Safety Reports

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Drug Information: Rosuvastatin

Why is this medication prescribed?

Rosuvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in your blood. Rosuvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body.

Buildup of cholesterol and other fats along the walls of the blood vessels (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to the heart, brain, and other parts of the body. Lowering blood levels of cholesterol and fats may help to decrease your chances of getting heart disease, angina (chest pain), strokes, and heart attacks. In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your cholesterol blood levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY), exercise 30 minutes on most, if not all, days and lose weight if you are overweight.

How should this medicine be used?

Rosuvastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take rosuvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rosuvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of rosuvastatin and gradually increase your dose, not more than once every 2-4 weeks.

Continue to take rosuvastatin even if you feel well. Do not stop taking rosuvastatin without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking rosuvastatin,

• tell your doctor and pharmacist if you are allergic to rosuvastatin or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); ketoconazole (Nizoral); other medications for high cholesterol such as clofibrate (Atromid-S), fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (Niaspan, Niacor); and spironolactone (Aldactone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking aluminum and magnesium hydroxide antacids (Mylanta, Maalox), take them at least 2 hours after rosuvastatin.
• tell your doctor if you have liver disease. Your doctor will probably tell you not to take rosuvastatin.
• tell your doctor if you drink large amounts of alcohol, if you have ever had liver disease, or if you have or have ever had kidney or thyroid disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rosuvastatin, call your doctor immediately. Rosuvastatin may harm the fetus.
• Do not breastfeed while taking rosuvastatin.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rosuvastatin.
• ask your doctor about the safe use of alcoholic beverages while you are taking rosuvastatin. Alcohol can increase the risk of serious side effects.

What special dietary instructions should I follow?

Eat a low-cholesterol, low-fat diet. This kind of diet includes cottage cheese, fat-free milk, fish (not canned in oil), vegetables, poultry, egg whites, and polyunsaturated oils and margarines (corn, safflower, canola, and soybean oils). Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, lard, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Rosuvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• heartburn
• dizziness
• difficulty falling asleep or staying asleep
• depression
• joint pain
• cough

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• muscle pain, tenderness, or weakness
• lack of energy
• fever
• chest pain
• yellowing of the skin or eyes
• pain in the upper right part of the abdomen
• nausea
• extreme tiredness
• unusual bleeding or bruising
• loss of appetite
• flu-like symptoms
• sore throat, chills, or other signs of infection
• rash
• hives
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• numbness or tingling in fingers or toes

Rosuvastatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to rosuvastatin.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking rosuvastatin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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