Rosuvastatin calcium 10 MG Oral Tablet
1 INDICATIONS AND USAGE 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 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 calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias. 1.3 Hypertriglyceridemia Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with homozygous familial hypercholesterolemia Rosuvastatin calcium 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. 1.8 Limitations of Use Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
Teva Pharmaceuticals USA, Inc.
ROUND PINK TV 7571
TV 7571 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin calcium tablets are available as: 5 mg – white, round, standard-convex, coated tablets, debossed with “TV” on one side and with “7570” on the other side of the tablet, in bottles of 90 (NDC 0093-7570-98). 10 mg – pink, round, standard-convex, coated tablets, debossed with “TV” on one side and with “7571” on the other side of the tablet, in bottles of 90 (NDC 0093-7571-98). 20 mg – pink, round, standard-convex, coated tablets, debossed with “TV” on one side and with “7572” on the other side of the tablet, in bottles of 90 (NDC 0093-7572-98). 40 mg – pink, oval-shaped, coated tablets, debossed with “TV” on one side and with “7573” on the other side of the tablet, in bottles of 30 (NDC 0093-7573-56). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
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