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Drug Catalog - Product Detail

ROSUVASTATIN CALCIUM 5MG TABLETS 90CT

NDC Mfr Size Str Form
16252-0615-90 ACTAVIS PHARMA 90 5MG TABLET
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Description
11 DESCRIPTION Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: microcrystalline cellulose, lactose monohydrate, sodium carbonate monohydrate, sodium dodecyl sulfate, crospovidone, magnesium stearate, titanium dioxide, polyethylene glycol, polyvinyl alcohol, talc, and iron oxide yellow. The 10 mg, 20 mg and 40 mg tablets also contain iron oxide red, FD&C red # 40, and FD&C blue #2. The following structural formula for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid].
How Supplied
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.
Indications & Usage
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.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Rosuvastatin calcium tablets can be taken with or without food, at any time of day. ( 2.1 ) Dose range: 5 mg to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ( 2.1 ) Adult HoFH: Starting dose 20 mg/day ( 2.1 ) Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age ( 2.2 ) 2.1 General Dosing Information The dose range for rosuvastatin calcium tablets in adults is 5 mg to 40 mg orally once daily. The usual starting dose is 10 mg to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily. The maximum rosuvastatin calcium tablets dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1) ]. Rosuvastatin calcium tablets can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole. When initiating rosuvastatin calcium tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin calcium tablets starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy. After initiation or upon titration of rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. 2.2 Pediatric Dosing In homozygous familial hypercholesterolemia, the recommended dose is 20 mg orally once daily in patients 7 to 17 years of age. Pediatric use information for patients ages 8 to less than 10 years is appr oved for AstraZeneca’s CRESTOR ( ros uvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2. 3 Dosing in Asian Patients In Asian patients, consider initiation of rosuvastatin calcium tablets therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3) ] . 2. 4 Use with Concomitant Therapy Patients taking cyclosporine The dose of rosuvastatin calcium tablets should not exceed 5 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , and Clinical Pharmacology (12.3) ] . Patients taking gemfibrozil Avoid concomitant use of rosuvastatin calcium tablets with gemfibrozil. If concomitant use cannot be avoided, initiate rosuvastatin calcium tablets at 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.2) , and Clinical Pharmacology (12.3) ] . Patients taking atazanavir and ritonavir, lopinavir and ritonavir , or simeprevir Initiate rosuvastatin calcium tablets therapy with 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 2. 5 Dosing in Patients with Severe Renal Impairment For patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, dosing of rosuvastatin calcium tablets should be started at 5 mg once daily and not exceed 10 mg once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .