Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Carilion Materials Management
ROSUVASTATIN CALCIUM
ROSUVASTATIN 5 mg
ORAL
PRESCRIPTION DRUG
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: 68151-4634 NDC: 68151-4634-9 1 TABLET, FILM COATED in a PACKAGE
New Drug Application
CRESTOR- ROSUVASTATIN CALCIUM TABLET, FILM COATED CARILION MATERIALS MANAGEMENT ---------- 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 • • • INDICATIONS AND USAGE CRESTOR is an HMG Co-A reductase inhibitor indicated for: • • • • • • • • Limitations of use(1.8): CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias. DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • 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 Pročitajte cijeli dokument