CRESTOR Rosuvastatin calcium
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
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 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:
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| What should I tell my doctor before and while taking CRESTOR? Tell your doctor if you:
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| 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:
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?
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| What are the Possible Side Effects of CRESTOR? CRESTOR may cause serious side effects, including:
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| 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?
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