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:

Cardinal Health

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 10 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. 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 post-menarche, 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 hypertrig

Product summary:

CRESTOR® (rosuvastatin calcium) Tablets are supplied as: Storage Store at controlled room temperature, 20‑25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

New Drug Application

Summary of Product characteristics

CRESTOR- ROSUVASTATIN CALCIUM TABLET, FILM COATED
CARDINAL HEALTH
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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
INDICATIONS AND USAGE
CRESTOR is an HMG Co A reductase inhibitor indicated for:
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Limitations of use (1.7):
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most frequent adverse reactions (rate > 2%) are headache, myalgia,
abdominal pain, asthenia, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA OR FDA AT
1-800-FDA-1088 OR
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)
patients with hypertriglyceridemia as an adjunct to diet (1.2)
patients with primary dysbetalipoproteinemia (Type III
hyperlipoproteinemia) as an adjunct to diet (1.3)
patients with homozygous familial hypercholesterolemia (HoFH) to
reduce LDL C, total-C, and ApoB (1.4)
slowing the progression of atherosclerosis as part of a treatment
strategy to lower total C and LDL C as an adjunct to
diet (1.5)
pediatric patients 10 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 (1.1)
risk reduction of MI, stroke, and arterial revascularization
procedures in patients without clinically evident CHD, but
with multiple risk factors (1.6)
CRESTOR has not been studied in Fredrickson Type I and V
dyslipidemias.
CRESTOR can be taken with or without food, at any time of day. (2.1)
Dose range: 5 40 mg once daily. Use 40 mg dose only for patients not
reaching LDL C goal with 20 mg. (2.1)
HOFH: Starting