Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Sandoz Inc
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 calcium tablets are indicated: Rosuvastatin calcium tablets are contraindicated in the following conditions: Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on th
Rosuvastatin calcium tablets are supplied as: 5 mg: Light brown, round, film-coated tablets with "RSV 5" debossed on one side. NDC 0781-5400-31, bottles of 30 tablets NDC 0781-5400-92, bottles of 90 tablets NDC 0781-5400-34, bottles of 3000 tablets NDC 0781-5400-13, carton of 100 tablets (10 x 10 Unit-dose) 10 mg: Brown, round, film-coated tablets with "RSV 10" debossed on one side. NDC 0781-5401-31, bottles of 30 tablets NDC 0781-5401-92, bottles of 90 tablets NDC 0781-5401-34, bottles of 3000 tablets NDC 0781-5401-13, carton of 100 tablets (10 x 10 Unit-dose) 20 mg: Brown, round, film-coated tablets with "RSV 20" debossed on one side. NDC 0781-5402-31, bottles of 30 tablets NDC 0781-5402-92, bottles of 90 tablets NDC 0781-5402-34, bottles of 3000 tablets NDC 0781-5402-13, carton of 100 tablets (10 x 10 Unit-dose) 40 mg: Brown, round, film-coated tablets with "RSV 40" debossed on one side. NDC 0781-5403-31, bottles of 30 tablets NDC 0781-5403-92, bottles of 90 tablets NDC 0781-5403-34, bottles of 3000 tablets NDC 0781-5403-13, carton of 100 tablets (10 x 10 Unit-dose) Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ROSUVASTATIN CALCIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 RECENT MAJOR CHANGES Contraindications, Pregnancy and Lactation (4) Removed 01/2023 Warnings and Precautions (5.2) 01/2023 Warnings and Precautions, Concomitant Coumarin Anticoagulants (5.4) Removed 01/2023 INDICATIONS AND USAGE Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor (statin) indicated: (1) • • • • • • o o DOSAGE AND ADMINISTRATION Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin, and adjust dosage if necessary. (2.1) _Adults:_ Recommended dosage range is 5 to 40 mg once daily. (2.1) _Pediatric Patients with HeFH: _Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. (2.2) _Asian Patients: _Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily. (2.4) _Patients with Severe Renal Impairment (not on hemodialysis):_ Initiate at 5 mg once daily; do not exceed 10 mg once daily. (2.5, 5.1, 8.6) See full prescribing information for rosuvastatin dosage and administration modifications due to drug interactions. (2.6) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. (3) CONTRAINDICATIONS WARNINGS AND PRECAUTIONS • To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to reduce LDL-C in adults with primary hyp Belgenin tamamını okuyun