Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Crestor

Descriptions


Rosuvastatin is used together with a proper diet to lower bad cholesterol (LDL) and triglycerides (fats) in the blood, and to increase your good cholesterol (HDL). It is also used to treat adults who cannot control their cholesterol levels by diet and exercise alone. Rosuvastatin 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
  • Capsule

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 tablet in children 7 years of age and older. However, safety and efficacy have not been established in children younger than 7 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of rosuvastatin capsule in the pediatric population. Safety and efficacy have not been established.

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.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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.

  • Abiraterone Acetate
  • Amprenavir
  • Atazanavir
  • Bezafibrate
  • Capmatinib
  • Ciprofibrate
  • Cobicistat
  • Colchicine
  • Cyclosporine
  • Daptomycin
  • Darolutamide
  • Darunavir
  • Dasabuvir
  • Elagolix
  • Elbasvir
  • Eluxadoline
  • Enasidenib
  • Eslicarbazepine Acetate
  • Fenofibrate
  • Fenofibric Acid
  • Fosamprenavir
  • Gemfibrozil
  • Grazoprevir
  • Indinavir
  • Lasmiditan
  • Ledipasvir
  • Leflunomide
  • Lopinavir
  • Niacin
  • Ombitasvir
  • Paritaprevir
  • Regorafenib
  • Ritonavir
  • Rolapitant
  • Saquinavir
  • Simeprevir
  • Tafamidis
  • Teriflunomide
  • Velpatasvir
  • Voxilaprevir
  • Warfarin

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
  • Dicumarol
  • Eltrombopag
  • Fluconazole
  • Fostemsavir
  • Glecaprevir
  • Itraconazole
  • Oat Bran
  • Pectin
  • Phenprocoumon
  • Pibrentasvir
  • Tipranavir

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 leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole. Do not break, crush, or chew it.

To use the capsule:

  • Swallow the capsule whole. Do not crush or chew it. If you have trouble swallowing, you may open it and mix the contents with 1 teaspoon of soft food (eg, applesauce, or chocolate or vanilla pudding). Take this mixture within 1 hour, without chewing. Do not save the mixture for later use. Throw away any unused mixture.
  • You may also take the capsule using a nasogastric tube. To use:
    • Open the capsule and empty the contents into a 60-milliliter (mL) catheter syringe. Add 40 mL of water. Do not use any other liquid.
    • Replace the plunger and shake the syringe for 15 seconds. The granules may start dissolving.
    • Attach the syringe to a nasogastric tube and deliver the contents into the stomach.
    • Flush the tube with an additional 20 mL of water to get all of the medicine.
    • Throw away any unused mixture.

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

Do not drink large amounts of alcohol while using 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 (capsules):
    • For homozygous familial hypercholesterolemia:
      • Adults—At first, 20 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg.
      • Children—Use and dose must be determined by your doctor.
    • For hypertriglyceridemia or primary dysbetalipoproteinemia (Type III hyperlipoproteinemia):
      • Adults—At first, 10 to 20 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For atherosclerosis:
      • Adults—5 to 40 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.
    • For heterozygous familial hypercholesterolemia:
      • Adults—5 to 40 milligrams (mg) once a day.
      • Children 10 to 17 years of age—5 to 20 mg per day.
      • Children 8 to 9 years of age—5 to 10 mg per day.
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    • For homozygous familial hypercholesterolemia:
      • Adults—At first, 20 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children 7 to 17 years of age—20 mg once a day.
      • Children younger than 7 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 of each other.

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 and urine 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 if you develop other serious health problems.

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

Call your doctor right away if you have dark 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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:

More common

  1. Difficulty in moving
  2. joint pain or swelling
  3. muscle pain, cramps, spasms, or stiffness

Less common

  1. Blurred vision
  2. chest pain, discomfort, tightness, or heaviness
  3. difficult, burning, or painful urination
  4. dry mouth
  5. fast, irregular, pounding, or racing heartbeat or pulse
  6. flushed, dry skin
  7. fruit-like breath odor
  8. increased hunger
  9. increased thirst
  10. increased urination
  11. loss of consciousness
  12. muscle tension or tightness
  13. nausea
  14. slow heartbeat
  15. stomachache
  16. sweating
  17. trouble breathing
  18. unexplained weight loss
  19. unusual tiredness or weakness
  20. vomiting

Rare

  1. Dark urine
  2. fever

Incidence not known

  1. Black, tarry stools
  2. bleeding gums
  3. bloating
  4. bloody urine
  5. chills
  6. clay-colored stools
  7. constipation
  8. cough
  9. general feeling of tiredness or weakness
  10. headache
  11. hives, itching, skin rash
  12. hoarseness
  13. indigestion
  14. irritation
  15. joint swelling
  16. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  17. light-colored stools
  18. loss of appetite
  19. muscle tenderness, wasting, or weakness
  20. pains in the stomach, side, or abdomen, possibly radiating to the back
  21. pinpoint red spots on the skin
  22. redness of the skin
  23. stomach pain, continuing
  24. swelling of the eyelids, face, lips, hands, or feet
  25. tightness in the chest
  26. trouble swallowing
  27. unpleasant breath odor
  28. unusual bleeding or bruising
  29. upper right abdominal or stomach pain
  30. vomiting of blood
  31. 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. dry or sore throat
  4. runny nose
  5. tender, swollen glands in the neck
  6. voice changes

Less common

  1. Accidental injury
  2. accumulation of pus, swollen, red, or tender area of infection near a tooth
  3. arm, back, or jaw pain
  4. belching
  5. bladder pain
  6. burning feeling in the chest or stomach
  7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  8. diarrhea
  9. discouragement
  10. dizziness
  11. excess air or gas in the stomach or bowels
  12. excessive muscle tone
  13. fear
  14. feeling faint
  15. feeling of constant movement of self or surroundings
  16. feeling of warmth or heat
  17. feeling sad or empty
  18. flushing or redness of the skin, especially on the face and neck
  19. general feeling of discomfort or illness
  20. heartburn
  21. lack of appetite
  22. lack or loss of strength
  23. lightheadedness
  24. loss of interest or pleasure
  25. neck pain
  26. nerve pain
  27. nervousness
  28. pain or swelling in the arms or legs without any injury
  29. pain or tenderness around the eyes and cheekbones
  30. passing gas
  31. pounding in the ears
  32. sensation of spinning
  33. shivering
  34. sneezing
  35. stomach discomfort, tenderness, or upset
  36. stuffy nose
  37. trouble concentrating
  38. trouble sleeping

Incidence not known

  1. Confusion
  2. forgetfulness
  3. memory loss
  4. nightmares
  5. swelling of the breasts or breast soreness in both females and males
  6. unsteadiness or awkwardness
  7. weakness in the arms, hands, legs, or feet

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.