Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Bryant Ranch Prepack
ROSUVASTATIN CALCIUM
ROSUVASTATIN 5 mg
ORAL
PRESCRIPTION DRUG
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 rights, this drug product is not labeled with that pediatric information. Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin tablets are 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. Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias. Rosuvastatin is contraindicated in the following conditions: - Patients with a known hypersensitivity to any component of this produc
Rosuvastatin tablets USP are supplied as: Rosuvastatin tablets USP, 5 mg are yellow colored, round, biconvex, film coated tablets debossed with '79' on one side and plain on other side. NDC: 63629-7158-1: 30 Tablets in a BOTTLE NDC: 63629-7158-2: 90 Tablets in a BOTTLE NDC: 63629-7158-3: 28 Tablets in a BOTTLE NDC: 63629-7158-4: 60 Tablets in a BOTTLE NDC: 63629-7158-5: 100 Tablets in a BOTTLE Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, 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 RECENT MAJOR CHANGES Dosage and Administration, Use with Concomitant Therapy ( 2.4) 5/2020 Warning and Precautions, Skeletal Muscle Effects ( 5.1) 5/2020 Warning and Precautions, Immune-Mediated Necrotizing Myopathy ( 5.2) 9/2020 INDICATIONS AND USAGE Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for: 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) 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) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg, 20 mg, and 40 mg ( 3) CONTRAINDICATIONS Known hypersensitivity to product components ( 4) Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4) Pregnancy ( 4 , 8.1, 8.3) Lactation ( 4, 8.2) WARNINGS AND PRECAUTIONS SKELETAL MUSCLE EFFECTS (E.G., MYOPATHY AND RHABDOMYOLYSIS) : Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, darolutamide, regorafenib, certain anti-viral medicines or their combinations. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuri Citiți documentul complet