Rosuvastatin calcium 10 MG Oral Tablet
1 INDICATIONS AND USAGE Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor indicated for: pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, non-HDL-C and Apo-B as an adjunct to diet, either alone or with other lipid-lowering treatments ( 1.2 ) 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. 1.2 Pediatric Patients with Familial Hypercholesterolemia Rosuvastatin calcium tablets are indicated as an adjunct to diet to: ● reduce LDL-C, Total-C, non-HDL-C and Apo-B in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis). Pediatric use information for patients ages 8 to less than 10 years 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. 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 Apo-B 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.
Actavis Pharma, Inc.
ROUND PINK RU10
RU10 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin calcium tablets are supplied as: 5 mg tablets: yellow, round convex shaped coated tablets with “RU5” on one side and blank on the other side. NDC 16252-615-30 bottles of 30 NDC 16252-615-90 bottles of 90 NDC 16252-615-50 bottles of 500 10 mg tablets: pink, round convex shaped coated tablets with “RU10” on one side and blank on the other side. NDC 16252-616-30 bottles of 30 NDC 16252-616-90 bottles of 90 NDC 16252-616-50 bottles of 500 20 mg tablets: pink, round convex shaped coated tablets with “RU20” on one side and blank on the other side. NDC 16252-617-30 bottles of 30 NDC 16252-617-90 bottles of 90 NDC 16252-617-50 bottles of 500 40 mg tablets: pink, oval shaped coated tablets with “RU40” on one side and blank on the other side. NDC 16252-618-30 bottles of 30 NDC 16252-618-90 bottles of 90 NDC 16252-618-50 bottles of 500 Storage Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from moisture.
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