CRESTOR Rosuvastatin calcium

Get an overview of CRESTOR (rosuvastatin calcium tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in CRESTOR can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as CRESTOR.

Drug Basics

Brand Name: CRESTOR

Generic Name: ROSUVASTATIN CALCIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2020-06-08

Dosage and Administration, Use with Concomitant Therapy (2.4)                                 5/2020

Warning and Precautions, Skeletal Muscle Effects (5.1)                                                 5/2020

indications & usage

CRESTOR is an HMG Co-A reductase inhibitor indicated for:

  • adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C (1.1)
  • pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy (1.2)
  • pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, nonHDL-C and ApoB as an adjunct to diet, either alone or with other lipid-lowering treatments (1.2)
  • adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
  • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
  • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
  • slowing the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C as an adjunct to diet (1.6)
  • risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors (1.7)

Limitations of use (1.8): CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias.

hyperlipidemia & mixed dyslipidemia

CRESTOR is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL‑C, and triglycerides and to increase HDL‑C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

pediatric patients with familial hypercholesterolemia

CRESTOR is indicated as an adjunct to diet to:

  • reduce Total-C, LDL-C and ApoB levels in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dL, or >160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
  • reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).

hypertriglyceridemia

CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

primary dysbetalipoproteinemia (type iii hyperlipoproteinemia)

CRESTOR is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

adult patients with homozygous familial hypercholesterolemia

CRESTOR is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL‑C, Total‑C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

slowing of the progression of atherosclerosis

CRESTOR is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total‑C and LDL‑C to target levels.

primary prevention of cardiovascular disease

In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥50 years old in men and ≥60 years old in women, hsCRP ≥2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL‑C, smoking, or a family history of premature coronary heart disease, CRESTOR is indicated to:

  • reduce the risk of stroke
  • reduce the risk of myocardial infarction
  • reduce the risk of arterial revascularization procedures

limitations of use

CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias.

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients should be instructed not to take 2 doses of CRESTOR within 12 hours of each other.

Skeletal Muscle Effects

Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing CRESTOR.

Concomitant Use of Antacids

When taking CRESTOR with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after CRESTOR administration.

Embryofetal Toxicity

Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with CRESTOR [see Contraindications (4) and Use in Specific Populations (8.2)].

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

CRESTOR is a trademark of the AstraZeneca group of companies.

© AstraZeneca 2020

Licensed from SHIONOGI & CO., LTD., Osaka, Japan

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

PATIENT INFORMATION

CRESTOR® (Kres-tor)

rosuvastatin calcium

Tablets

Read this Patient Information carefully before you start taking CRESTOR and each time you get a refill. If you have any questions about CRESTOR, ask your doctor. Only your doctor can determine if CRESTOR is right for you.

What is CRESTOR?

CRESTOR is a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin calcium.

  • CRESTOR is used along with diet to:
    • lower the level of your “bad” cholesterol (LDL)
    • increase the level of your “good” cholesterol (HDL)
    • lower the level of fat in your blood (triglycerides)
    • slow the buildup of fatty deposits (plaque) in the walls of blood vessels
  • CRESTOR is used to treat:
    • adults who cannot control their cholesterol levels by diet and exercise alone
    • children 8 to 17 years of age with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL)
    • children 7 to 17 years of age with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL).

CRESTOR is not approved for use in children with heterozygous familial hypercholesterolemia younger than 8 years of age or for use in children with homozygous familial hypercholesterolemia younger than 7 years of age.

CRESTOR is used to reduce the risk of heart attacks and strokes in men 50 years of age and older and women 60 years of age and older who do not have known heart disease but do have certain additional risk factors.

It is not known if CRESTOR is safe and effective in people who have Fredrickson Type I and V dyslipidemias.

Who should not take CRESTOR?

Do not take CRESTOR if you:

  • are allergic to rosuvastatin calcium or any of the ingredients in CRESTOR. See the end of this leaflet for a complete list of ingredients in CRESTOR.
  • have liver problems.
  • are pregnant or think you may be pregnant, or are planning to become pregnant. CRESTOR may harm your unborn baby. If you become pregnant, stop taking CRESTOR and call your doctor right away. If you are not planning to become pregnant you should use effective birth control (contraception) while you are taking CRESTOR.
  • are breastfeeding. Medicines like CRESTOR can pass into your breast milk and may harm your baby.

What should I tell my doctor before and while taking CRESTOR?

Tell your doctor if you:

  • have unexplained muscle aches or weakness
  • have or have had kidney problems
  • have or have had liver problems
  • drink more than 2 glasses of alcohol daily
  • have thyroid problems
  • are 65 years of age or older
  • are of Asian descent
  • are pregnant or think you may be pregnant, or are planning to become pregnant
  • are breastfeeding

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Talk to your doctor before you start taking any new medicines.

Taking CRESTOR with certain other medicines may affect each other causing side effects. CRESTOR may affect the way other medicines work, and other medicines may affect how CRESTOR works.

Especially tell your doctor if you take:

  • cyclosporine (a medicine for your immune system)
  • gemfibrozil (a fibric acid medicine for lowering cholesterol)
  • darolutamide (a medicine for the treatment of prostate cancer)
  • regorafenib (a medicine used to treat cancer of the colon and rectum)
  • anti-viral medicines including certain HIV or hepatitis C virus drugs such as:
    • lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir
    • combination of
      • sofosbuvir/velpatasvir/voxilaprevir
      • dasabuvir/ombitasvir/paritaprevir/ritonavir
      • elbasvir/grazoprevir
      • sofosbuvir/velpatasvir
      • glecaprevir/pibrentasvir and
    • all other combinations with ledipasvir including ledipasvir/sofosbuvir
  • certain anti-fungal medicines (such as itraconazole, ketoconazole and fluconazole)
  • coumarin anticoagulants (medicines that prevent blood clots, such as warfarin)
  • niacin or nicotinic acid
  • fibric acid derivatives (such as fenofibrate)
  • colchicine (a medicine used to treat gout)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.

How should I take CRESTOR?

  • Take CRESTOR exactly as your doctor tells you to take it.
  • Take CRESTOR, by mouth, 1 time each day. Swallow the tablet whole.
  • CRESTOR can be taken at any time of day, with or without food.
  • Do not change your dose or stop CRESTOR without talking to your doctor, even if you are feeling well.
  • Your doctor may do blood tests to check your cholesterol levels before and during your treatment with CRESTOR. Your doctor may change your dose of CRESTOR if needed.
  • Your doctor may start you on a cholesterol lowering diet before giving you CRESTOR. Stay on this diet when you take CRESTOR.
  • Wait at least 2 hours after taking CRESTOR to take an antacid that contains a combination of aluminum and magnesium hydroxide.
  • If you miss a dose of CRESTOR, take it as soon as you remember. However, do not take 2 doses of CRESTOR within 12 hours of each other.
  • If you take too much CRESTOR or overdose, call your doctor or go to the nearest hospital emergency room right away.

What are the Possible Side Effects of CRESTOR?

CRESTOR may cause serious side effects, including:

  • Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if:
    • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take CRESTOR.
    • you have muscle problems that do not go away even after your doctor has told you to stop taking CRESTOR. Your doctor may do further tests to diagnose the cause of your muscle problems.
  •  Your chances of getting muscle problems are higher if you:
    • are taking certain other medicines while you take CRESTOR
    • are 65 years of age or older
    • have thyroid problems (hypothyroidism) that are not controlled
    • have kidney problems
    • are taking higher doses of CRESTOR
  • Liver problems. Your doctor should do blood tests to check your liver before you start taking CRESTOR and if you have symptoms of liver problems while you take CRESTOR. Call your doctor right away if you have any of the following symptoms of liver problems:

The most common side effects may include: headache, muscle aches and pains, abdominal pain, weakness, and nausea.

Additional side effects that have been reported with CRESTOR include memory loss and confusion.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of CRESTOR. For more information, ask your doctor or pharmacist.

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

How should I store CRESTOR?

  • Store CRESTOR at room temperature, between 68°F to 77°F (20°C to 25°C) and in a dry place.
  • Safely throw away medicine that is out of date or no longer needed.

Keep CRESTOR and all medicines out of the reach of children.

What are the Ingredients in CRESTOR?

Active Ingredient: rosuvastatin as rosuvastatin calcium

Inactive Ingredients: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF.

General Information about the safe and effective use of CRESTOR

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CRESTOR for a condition for which it was not prescribed. Do not give CRESTOR to other people, even if they have the same medical condition you have. It may harm them.

You can ask your pharmacist or doctor for information about CRESTOR that is written for health professionals.

CRESTOR is a trademark of the AstraZeneca group of companies.

© AstraZeneca 2020

Licensed from SHIONOGI & CO., LTD., Osaka, Japan

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

For more information, go to the CRESTOR website at www.crestor.com or call 1-800-CRESTOR.

This Patient Information has been approved by the U.S. Food and Drug Administration                             Revised 5/2020

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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