"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
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Hyperlipidemia and 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. Lipidaltering 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 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH)
Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10-17 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 and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
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 patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
Homozygous Familial Hypercholesterolemia
CRESTOR is indicated as adjunctive therapy to other lipidlowering 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.
DOSAGE AND ADMINISTRATION
General Dosing Information
The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.
CRESTOR can be administered as a single dose at any time of day, with or without food.
When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy.
After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.
The 40 mg dose of CRESTOR should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see WARNINGS AND PRECAUTIONS].
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)
The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE]. Adjustments should be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia
The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.
Dosing in Asian Patients
In Asian patients, consider initiation of CRESTOR therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day. [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
Use with Concomitant Therapy
Patients taking cyclosporine
Patients taking gemfibrozil
Patients taking lopinavir and ritonavir or atazanavir and ritonavir
Dosing in Patients with Severe Renal Impairment
For patients with severe renal impairment (CLcr < 30 mL/min/1.73 m²) not on hemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
5 mg: Yellow, round, biconvex, coated tablets. Debossed “CRESTOR”
and “5” on one side of the tablet.
10 mg: Pink, round, biconvex, coated tablets. Debossed “CRESTOR” and “10” on one side of the tablet.
20 mg: Pink, round, biconvex, coated tablets. Debossed “CRESTOR” and “20” on one side of the tablet.
40 mg: Pink, oval, biconvex, coated tablets. Debossed “CRESTOR” on one side and “40” on the other side of the tablet.
Storage And Handling
CRESTOR® (rosuvastatin calcium) Tablets are supplied as:
NDC 0310-0755-90: 5 mg. Yellow, round, biconvex, coated
tablets. Debossed “CRESTOR” and “5” on one side; bottle of 90 tablets
NDC 0310-0751-90: 10 mg. Pink, round, biconvex, coated tablets. Debossed “CRESTOR” and “10” on one side; bottle of 90 tablets
NDC 0310-0751-39: 10-mg. Pink, round, biconvex, coated tablets. Debossed “CRESTOR” and “10” on one side; unit dose packages of 100
NDC 0310-0752-90: 20 mg. Pink, round, biconvex, coated tablets. Debossed “CRESTOR” and “20” on one side; bottles of 90
NDC 0310-0752-39: 20 mg. Pink, round, biconvex, coated tablets. Debossed “CRESTOR” and “20”on one side; unit dose packages of 100
NDC 0310-0754-30: 40 mg. Pink, oval, biconvex, coated tablets. Debossed “CRESTOR” on one side and “40” on the other side; bottles of 30
Store at controlled room temperature, 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from moisture.
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Revised: August, 2013
Last reviewed on RxList: 8/16/2013
This monograph has been modified to include the generic and brand name in many instances.
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