Generic name: Rosuvastatin

What is Crestor?

Crestor (rosuvastatin) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rosuvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Crestor is used to lower cholesterol and triglycerides (types of fat) in the blood and to slow the build-up of plaque (fatty deposits) in your blood vessels.

Crestor is also used to lower the risk of stroke, heart attack, and other heart complications in certain people with diabetes, coronary heart disease, or other risk factors.

Crestor is used in adults and children who are at least 10 years old.

Important information

Crestor can harm an unborn baby or cause birth defects. Do not use this medicine if you are pregnant.

Before taking Crestor, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

In rare cases, Crestor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

You should not take rosuvastatin if you have liver disease, or if you breast-feeding a baby.

Avoid eating foods that are high in fat or cholesterol. Crestor will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

There are many other drugs that can increase your risk of serious medical problems if you take them together with Crestor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicinesand show it to any healthcare provider who treats you.

Crestor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Before taking this medicine

You should not take Crestor if you are allergic to rosuvastatin, or if you have:

• liver disease; or

• if you are pregnant or breast-feeding.

To make sure Crestor is safe for you, tell your doctor if you have:

• a history of liver disease;

• a history of kidney disease;

• diabetes;

• a thyroid disorder;

• if you drink more than 2 alcoholic beverages daily;

• if you are of Asian descent; or

• if you are 65 or older.

People of Asian descent may absorb Crestor at a higher rate than other people. Make sure your doctor knows if you are Asian. You may need a lower than normal starting dose.

Crestor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not take Crestor if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking this medicine.

Rosuvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking Crestor.

How should I take Crestor?

Take Crestor exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Crestor is usually taken once a day, with or without food. Take the medicine at the same time each day.

While using this medicine, you may need frequent blood tests.

Keep using this medicine as directed, even if you feel well. High cholesterol usually has no symptoms. You may need to take Crestor on a long-term basis.

You may need to stop using Crestor for a short time if you have:

• uncontrolled seizures;

• an electrolyte imbalance (such as high or low potassium levels in your blood);

• severely low blood pressure;

• a severe infection or illness;

• dehydration; or

• surgery or a medical emergency.

You should not stop using Crestor unless your doctor tells you to.

Crestor is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.

Crestor dosing information

Usual Adult Dose for Hyperlipoproteinemia:

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL):

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL VLDL):

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL):

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Atherosclerosis:

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: 20 mg once a day with or without food
Maintenance dose: 20 mg to 40 mg once a day with or without food

Usual Adult Dose for Prevention of Cardiovascular Disease:

Initial dose: 5 mg to 10 mg once a day with or without food Maintenance dose: 5 mg to 40 mg once a day with or without food

Response to therapy should be estimated from preapheresis LDL-C levels.

Usual Geriatric Dose for Hyperlipidemia:

Initial dose: 5 mg once a day with or without food
Maintenance dose: 5 mg to 20 mg once a day with or without food

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

Pediatric patients 10 to 17 years of age:

Usual dose range: 5 to 20 mg orally once a day with or without food. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

Maximum dose: 20 mg orally once a day

What other drugs will affect rosuvastatin?

Using certain other drugs together with rosuvastatin can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with rosuvastatin, especially:

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Crestor?

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends, and do not take it within 2 hours after taking Crestor. Some antacids can make it harder for your body to absorb rosuvastatin.

Avoid eating foods that are high in fat or cholesterol. Crestor will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Crestor side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Crestor: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Crestor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

• confusion, memory problems;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common Crestor side effects may include:

• liver symptoms (stomach pain, dark urine, jaundice);

• unusual weakness or tired feeling;

• headache, muscle aches; or

• nausea, upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Crestor?

Using certain other drugs together with Crestor can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with Crestor, especially:

• colchicine;

• cyclosporine;

• antifungal medicine - fluconazole, itraconazole, ketoconazole;

• another "statin" medicine - atorvastatin, lovastatin, simvastatin, Lipitor, Pravachol, Zocor, Vytorin, and others;

• a blood thinner - warfarin, Coumadin, Jantoven;

• other cholesterol medications - fenofibrate, gemfibrozil;

• HIV or AIDS medicine - atazanavir, fosamprenavir, lopinavir, ritonavir, tipranavir, and others; or

• medicines that contain niacin or nicotinic acid - vitamin B3, Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others.

This list is not complete. Other drugs may interact with rosuvastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.