In the U.S.—

In Canada—

• Antihyperlipidemic

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)

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.

Diet—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.

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.

• 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.

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.

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.

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.

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:

• Rare
  • Dark-colored urine;  fever;  muscular pain, tenderness, wasting or weakness;  muscle cramps or spasms;  muscle pain or stiffness;  unusual tiredness or weakness 
  
  

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.

• More Common
  • Body aches or pain ;  congestion;  cough;  dryness or soreness of throat ;  headache;  hoarseness;  runny nose;  tender, swollen glands in neck;  trouble in swallowing;  voice changes 
  
  

• Less common
  • Accidental injury;  accumulation of pus, swollen, red, tender area of infection near a tooth;  acid or sour stomach;  arm, back or jaw pain;  arthritis;  back pain;  belching;  bladder pain;  bloated;  bloody or cloudy urine;  blurred vision;  bruising;  burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings;  burning feeling in chest or stomach;  chest pain or discomfort;  chest tightness or heaviness;  chills;  constipation ;  depression;  diarrhea;  difficult, burning, or painful urination;  difficult or labored breathing;  difficulty having a bowel movement (stool);  difficulty in moving;  discouragement;  dizziness;  dry mouth;  excess air or gas in stomach or intestines;  excessive muscle tone;  fast, irregular, pounding, or racing heartbeat or pulse;  fatigue;  fear;  feeling of constant movement of self or surroundings;  feeling of warmth or heat;  feeling faint;  feeling sad or empty;  flatulence;  flushed, dry skin;  flushing or redness of skin especially on face and neck;  frequent urge to urinate;  fruit-like breath odor;  full feeling;  general feeling of discomfort or illness;  heartburn;  increased hunger;  increased thirst;  increased urination;  indigestion;  infection;  irritability;  itching skin;  joint pain;  lack of appetite;  lack or loss of strength ;  large, flat, blue or purplish patches in the skin ;  light-headedness;  loss of appetite;  loss of consciousness;  loss of interest or pleasure;  lower back or side pain;  muscle tension or tightness;  nausea;  neck pain;  nerve pain;  nervousness;  noisy breathing;  pain;  pain or swelling in arms or legs without any injury;  pain, swelling, or redness in joints;  pain or tenderness around eyes and cheekbones;  painful or difficult urination;  pale skin;  passing gas;  pounding in the ears;  sensation of spinning;  shivering;  shortness of breath;  sleeplessness;  slow heartbeat;  sneezing;  sore throat;  stomach pain, discomfort, tenderness, or upset;  stuffy nose;  sweating;  swelling of hands, ankles, feet, or lower legs;  tightness in chest;  troubled breathing;  trouble concentrating;  trouble sleeping;  unable to sleep;  unexplained weight loss;  unusual bleeding or bruising;  vomiting;  wheezing 
  
  

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