Rosuvastatin 5 mg
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 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 tablets have not been studied in Fredrickson Type I and V dyslipidemias. 1.3 Hypertriglyceridemia Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin 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 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 tablets have not been studied in Fredrickson Type I and V dyslipidemias.
camber pharmaceuticals, inc.
ROUND YELLOW R3 H
R3 H ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
ROSUVASTATIN Tablets USP are supplied as: 5 mg: Light yellow to yellow, round, bevel edged biconvex film coated tablets, debossed with 'H' on one side and 'R3' on the other side. They are supplied as follows. Bottle of 90 Tablets NDC 31722-882-90 Blister pack of 100 (10×10) Unit dose tablets NDC 31722-882-31 10 mg : Light pink to pink, round, bevel edged biconvex film coated tablets, debossed with 'H' on one side and 'R4' on the other side. They are supplied as follows. Bottle of 90 Tablets NDC 31722-883-90 Blister pack of 100 (10×10) Unit dose tablets NDC 31722-883-31 20 mg : Light pink to pink, round, bevel edged biconvex film coated tablets, debossed with 'H' on one side and 'R5' on the other side. They are supplied as follows. Bottle of 90 Tablets NDC 31722-884-90 Blister pack of 100 (10×10) Unit dose tablets NDC 31722-884-31 40 mg : Light pink to pink, oval, bevel edged biconvex film coated tablets, debossed with 'H' on one side and 'R6' on the other side. They are supplied as follows. Bottle of 30 Tablets NDC 31722-885-30 Blister pack of 100 (10×10) Unit dose tablets NDC 31722-885-31 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
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