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Home » Directories » FDA Approved Drugs » Crestor (rosuvastatin calcium)

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Crestor (rosuvastatin calcium)

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Contact Information

Contact: AstraZeneca
Website: https://www.crestor.com/

Currently Enrolling Trials

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    General Information

    Crestor (rosuvastatin calcium) is a synthetic lipid-lowering agent approved as a treatment for hypercholesterolemia. The drug is classified as a Statin, a type of agent that inhibits cholesterol production in the liver.

    Crestor is indicated for the following:

    • for the treatment of hypercholesterolemia
    • 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.
    • to treat patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia) as an adjunct to diet.
    • for the treatment of heterozygous familial hypercholesterolemia in adolescent boys and postmenarchal girls, ages 10 to 17 years, with a recommended dosing range of 5 to 20 mg once daily
    • for the primary prevention of cardiovascular disease
    • for treatment of 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.

    Crestor is supplied as tablets for oral administration. Crestor can be taken with or without food, at any time of day.

    Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg.

    • Adult HoFH: Starting dose 20 mg/day
    • Pediatric patients with HeFH: 5 to 10 mg/day for patients 8 to less than 10 years of age, and 5 to 20 mg/day for patients 10 to 17 years of age.
    • Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age

    Mechanism of Action

    Rosuvastatin is an inhibitor of HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

    Rosuvastatin reduces cholesterol by increasing the number of low-density lipoprotein (LDL) receptors on the cell-surface to enhance uptake and catabolism of LDL. It also inhibits hepatic synthesis of hepatic very-low-density lipoprotein (VLDL), which reduces the total number of VLDL and LDL particles. The treatment reduces triglycerides (TG) and produces increases in high-density lipoprotein cholesterol (HDL-C.)

    Side Effects

    Adverse events associated with the use of Crestor may include (but are not limited to) the following:

    • Pharyngitis
    • Headache
    • Diarrhea
    • Dyspepsia
    • Myalgia
    • Asthenia
    • Back Pain
    • Flu syndrome
    • Urinary tract infection

    Clinical Trial Results

    FDA approval of Crestor was based a double-blind, placebo-controlled, dose-ranging study and a open-label study of 2,240 subjects with type IIa and IIb hypercholesterolemia. Results demonstrated that Crestor reduced total-C, LDL-C, ApoB, nonHDL-C, and TG, and increases HDL-C, in patients with hypercholesterolemia and mixed dyslipidemia.

    Approval Date: 2003-08-01
    Company Name: AstraZeneca
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