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:

American Health Packaging

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rosuvastatin tablets are 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. Rosuvastatin tablets are 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. Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity r

Product summary:

Rosuvastatin Tablets USP 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side.  Unit dose packages of 100 (10 x 10) NDC 60687-234-01 Rosuvastatin Tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side.  Unit dose packages of 50 (5 x 10) NDC 60687-245-65  Unit dose packages of 100 (10 x 10) NDC 60687-245-01 Rosuvastatin Tablets USP 20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side.  Unit dose packages of 100 (10 x 10) NDC 60687-256-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROSUVASTATIN TABLETS.
ROSUVASTATIN TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Rosuvastatin tablets are 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)
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): Rosuvastatin tablets have not been studied
in Fredrickson Type I and V
dyslipidemias.
DOSAGE AND ADMINISTRATION
Rosuvastatin tablets can be taken with or without food, at any time of
day. (2.1)
Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients
not reaching LDL-C goal with 20
mg. (2.1)
Adult HoFH: Starting dose 20 mg/day. (2.1)
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. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to p