البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Tris Pharma Inc
ROSUVASTATIN CALCIUM
ROSUVASTATIN 5 mg
ORAL
PRESCRIPTION DRUG
Rosuvastatin calcium tablets is indicated: - 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 hyperlipidemia. - Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. - Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). - As an adjunct to diet for the treatment of adults with: - Primary dysbetalipoproteinemia. - Hypertriglyceridemia. Rosuvastatin calcium tablets is contraindicated i
Rosuvastatin calcium tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 90 tablets bottles of 500 tablets NDC 27808-155-01 NDC 27808-155-03 Pink, round, biconvex, coated tablets. Debossed as ‘CY’ on one side and ‘5’ on other side 10 mg bottles of 90 tablets bottles of 500 tablets NDC 27808-156-01 NDC 27808-156-03 Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘10’ on other side 20 mg bottles of 90 tablets bottles of 500 tablets NDC 27808-157-01 NDC 27808-157-03 Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘20’ on other side 40 mg bottles of 30 tablets bottles of 500 tablets NDC 27808-158-01 NDC 27808-158-03 Pink, round, biconvex, coated tablet. Debossed as ‘CY’ on one side, and ‘40’ on other side Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED TRIS PHARMA 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 Dosage and Administration Modifications Due to Drug Interactions (2.6) 07/2023 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 is an HMG Co-A reductase inhibitor (statin) indicated: (1) 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 hyperlipidemia. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. As an adjunct to diet to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. DOSAGE AND ADMINISTRATION Take orally with or without food, at any time of day. (2.1) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin calcium tablets, and adjust dosage if necessary. (2.1) _Adults: _Recommended dosage range is 5 to 40 mg once daily. (2.1) _Pediatric Pati اقرأ الوثيقة كاملة