Rosuvastatin calcium 40 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 tablet is 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 has not been studied in Fredrickson Type I and V dyslipidemias.
par pharmaceutical, inc.
OVAL WHITE par 263
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16 HOW SUPPLIED Rosuvastatin calcium tablets are supplied as: 5 mg: light red, round biconvex tablet, debossed “par” on one side and “260” on the other. NDC 49884-260-09 Bottles of 90 10 mg: white to off white, round biconvex tablet, debossed “par” on one side and “261” on the other. NDC 49884-261-09 Bottles of 90 20 mg: light blue, round biconvex tablet, debossed “par” on one side and “262” on the other. NDC 49884-262-09 Bottles of 90 40 mg: white to off white, oval shape, biconvex tablet, debossed “par” on one side and “263” on the other. NDC 49884-263-11 Bottles of 30 Storage Store at controlled room temperature, 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture.
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