CRESTOR- rosuvastatin calcium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)

Available from:

Carilion Materials Management

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. CRESTOR is indicated as an adjunct to diet to: CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. CRESTOR is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 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. CRESTOR is indicated as adjunctive therapy to diet to slow the progress

Product summary:

Product: 68151-4634 NDC: 68151-4634-9 1 TABLET, FILM COATED in a PACKAGE

Authorization status:

New Drug Application

Summary of Product characteristics

CRESTOR- ROSUVASTATIN CALCIUM TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CRESTOR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CRESTOR.
CRESTOR (ROSUVASTATIN CALCIUM) TABLETS
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
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INDICATIONS AND USAGE
CRESTOR is an HMG Co-A reductase inhibitor indicated for:
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Limitations of use(1.8): CRESTOR has not been studied in Fredrickson
Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Indications and Usage (1.2) 5/2016
Dosage and Administration (2.2) 5/2016
Contraindications (4) 5/2016
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)
CRESTOR can be take