Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Crestor

Descriptions


Rosuvastatin is used together with a proper diet to lower cholesterol and triglycerides (fats) in the blood. This medicine may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

Rosuvastatin belongs to a group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, so this reduces the amount of cholesterol in the blood.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rosuvastatin in children. However, safety and efficacy have not been established in children younger than 10 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rosuvastatin in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving rosuvastatin.

Pregnancy

Information about this rosuvastatin-oral-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Cyclosporine
  • Daptomycin
  • Erlotinib
  • Fenofibrate
  • Fenofibric Acid
  • Fosamprenavir
  • Gemfibrozil
  • Indinavir
  • Lopinavir
  • Niacin
  • Saquinavir
  • Simeprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Amiodarone
  • Desogestrel
  • Dicumarol
  • Dienogest
  • Drospirenone
  • Eltrombopag
  • Eslicarbazepine Acetate
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fluconazole
  • Itraconazole
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Oat Bran
  • Pectin
  • Phenprocoumon
  • Tipranavir
  • Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Alcohol abuse, or history of or
  • Liver disease, history of—Use with caution. May cause side effects to become worse.
  • Asian descent—May need a lower dose of this medicine.
  • Convulsions (seizures), not well-controlled or
  • Dehydration or
  • Electrolyte deficiency or disorder, severe or
  • Endocrine disorder, severe or
  • Hypotension (low blood pressure) or
  • Hypothyroidism (underactive thyroid), inadequately treated or
  • Kidney disease, severe or
  • Major surgery or trauma, recent or
  • Metabolic enzyme deficiency or disorder, severe or
  • Sepsis (severe infection)—Patients with these conditions may be at risk for muscle or kidney problems.
  • Diabetes—Use with caution. May make this condition worse.
  • Liver disease, active or
  • Liver enzymes, elevated—Should not be used in patients with these conditions.

Proper Use

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it 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.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk to your doctor if you have any questions.

Swallow the tablet whole. Do not break, crush, or chew it. You may take this medicine with or without food.

If you need to take an antacid that contains aluminum and magnesium (e.g., Maalox®), take the antacid at least 2 hours after you take rosuvastatin.

Do not drink large amounts of alcohol while taking rosuvastatin. This could cause side effects on the liver.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

  • For oral dosage form (tablets):
    • For high cholesterol and atherosclerosis:
      • Adults—5 to 40 milligrams (mg) once a day.
      • Children 10 to 17 years of age—5 to 20 mg per day.
      • Children younger than 10 years of age—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.

However, do not take 2 doses of this medicine within 12 hours.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

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. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, major injury, or you develop other serious health problems.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These could be symptoms of serious muscle problems such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.

Do not stop or change your dose without checking first with your doctor, even if you are feeling well.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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

  1. Dark-colored urine
  2. fever
  3. muscle cramps or spasms
  4. muscle pain, stiffness, tenderness, wasting, or weakness
  5. unusual tiredness or weakness

Incidence not known

  1. Abdominal or stomach pain
  2. clay-colored stools
  3. skin rash
  4. unpleasant breath odor
  5. vomiting of blood
  6. yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Body aches or pain
  2. congestion
  3. cough
  4. dry or sore throat
  5. headache
  6. hoarseness
  7. runny nose
  8. tender, swollen glands in the neck
  9. trouble swallowing
  10. voice changes

Less common

  1. Accidental injury
  2. accumulation of pus, swollen, red, or tender area of infection near a tooth
  3. acid or sour stomach
  4. arm, back, or jaw pain
  5. belching
  6. bladder pain
  7. bloated or full feeling
  8. bloody or cloudy urine
  9. blurred vision
  10. burning feeling in the chest or stomach
  11. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  12. chest pain or discomfort
  13. chest tightness or heaviness
  14. chills
  15. constipation
  16. depression
  17. diarrhea
  18. difficult or labored breathing
  19. difficult, burning, or painful urination
  20. difficulty with moving
  21. discouragement
  22. dizziness
  23. dry mouth
  24. excess air or gas in the stomach or intestines
  25. excessive muscle tone
  26. fast, irregular, pounding, or racing heartbeat or pulse
  27. fear
  28. feeling faint
  29. feeling of constant movement of self or surroundings
  30. feeling of warmth or heat
  31. feeling sad or empty
  32. flushed, dry skin
  33. flushing or redness of the skin especially on the face and neck
  34. fruit-like breath odor
  35. general feeling of discomfort or illness
  36. heartburn
  37. increased hunger
  38. increased thirst
  39. increased urination
  40. irritability
  41. itching skin
  42. lack of appetite
  43. lack or loss of strength
  44. lightheadedness
  45. loss of appetite
  46. loss of consciousness
  47. loss of interest or pleasure
  48. muscle tension or tightness
  49. nausea
  50. neck pain
  51. nerve pain
  52. nervousness
  53. pain or swelling in the arms or legs without any injury
  54. pain or tenderness around the eyes and cheekbones
  55. pain, swelling, or redness in the joints
  56. pale skin
  57. passing gas
  58. pounding in the ears
  59. sensation of spinning
  60. shivering
  61. shortness of breath
  62. sleeplessness
  63. slow heartbeat
  64. sneezing
  65. stomach pain, discomfort, tenderness, or upset
  66. stuffy nose
  67. sweating
  68. swelling of the hands, ankles, feet, or lower legs
  69. trouble concentrating
  70. trouble sleeping
  71. troubled breathing
  72. unable to sleep
  73. unexplained weight loss
  74. unusual bleeding or bruising
  75. vomiting

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.