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 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 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.
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ROUND YELLOW FI 5
FI 5 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
ROSUVASTATIN tablets, USP are supplied as: NDC 16729-284: 5 mg. yellow, round, biconvex, film-coated tablet, debossed “5” on one side and “FI” on other side; Bottle of 30 tablets with child-resistant closure NDC 16729-284-10 Bottle of 90 tablets with child-resistant closure NDC 16729-284-15 Bottle of 1000 tablets NDC 16729-284-17 NDC 16729-285: 10 mg. pink, round, biconvex, film-coated tablet, debossed “10” on one side and “R” on other side; Bottle of 30 tablets with child-resistant closure NDC 16729-285-10 Bottle of 90 tablets with child-resistant closure NDC 16729-285-15 Bottle of 1000 tablets NDC 16729-285-17 NDC 16729-286: 20 mg. pink, round, biconvex, film-coated tablet, debossed “20” on one side and “R” on other side; Bottle of 30 tablets with child-resistant closure NDC 16729-286-10 Bottle of 90 tablets with child-resistant closure NDC 16729-286-15 Bottle of 1000 tablets NDC 16729-286-17 NDC 16729-287: 40 mg. pink, oval, biconvex, film-coated tablet, debossed “40” on one side and “R” on other side; Bottle of 30 tablets with child-resistant closure NDC 16729-287-10 Bottle of 90 tablets with child-resistant closure NDC 16729-287-15 Bottle of 1000 tablets NDC 16729-287-17 Storage Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
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