Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Bryant Ranch Prepack
ROSUVASTATIN CALCIUM
ROSUVASTATIN 10 mg
ORAL
PRESCRIPTION DRUG
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
NDC: 63629-7157-4: 120 Tablets in a BOTTLE NDC: 63629-7157-5: 180 Tablets in a BOTTLE NDC: 63629-7157-6: 100 Tablets in a BOTTLE NDC: 63629-7157-1: 30 Tablets in a BOTTLE NDC: 63629-7157-2: 90 Tablets in a BOTTLE NDC: 63629-7157-3: 60 Tablets in a BOTTLE
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED BRYANT RANCH PREPACK ---------- 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 produc Lire le document complet