国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
REMEDYREPACK INC.
ROSUVASTATIN CALCIUM
ROSUVASTATIN 20 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 tablets are contraindicated in the following conditions: - Patients with a known hypersensitivity to an
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. Bottles of 30 NDC 57237-168-30 Bottles of 90 NDC 57237-168-90 Bottles of 500 NDC 57237-168-05 Bottles of 1,000 NDC 57237-168-99 Rosuvastatin Tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side. Bottles of 30 NDC 57237-169-30 Bottles of 90 NDC 57237-169-90 Bottles of 500 NDC 57237-169-05 Bottles of 1,000 NDC 57237-169-99 Rosuvastatin Tablets USP 20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side. Bottles of 30 NDC 57237-170-30 Bottles of 90 NDC 57237-170-90 Bottles of 500 NDC 57237-170-05 Bottles of 1,000 NDC 57237-170-99 Rosuvastatin Tablets USP 40 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘32’ on the other side. Bottles of 30 NDC 57237-171-30 Bottles of 90 NDC 57237-171-90 Bottles of 500 NDC 57237-171-05 Bottles of 1,000 NDC 57237-171-99 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.
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED REMEDYREPACK INC. ---------- 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 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, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin if signs or symptoms appear. (5.1, 7.5, 7.6) LIVER ENZYME ABNORMALITIES: Persistent elevations i 阅读完整的文件