RVP

Drug Catalog - Product Detail

ROSUVASTATIN TAB 20MG 1000CT

NDC Mfr Size Str Form
72205-0004-99 NOVADOZ PHARMACEUTICALS 1000 20MG TABLET
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Description
11 DESCRIPTION Rosuvastatin calcium, USP 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 molecular formula for rosuvastatin calcium, USP 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 ethanol, 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 tablets, USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, lactose monohydrate magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No. 40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets are supplied as: Rosuvastatin Tablets,USP 5 mg are available as White, round shaped, biconvex, film coated tablets debossed with "R5" on one side and plain on other side. Bottle of 90 tablets NDC-72205-027-90 Bottle of 500 tablets NDC-72205-027-05 Bottle of 1000 tablets NDC-72205-027-99 Cartons of 100 (10 x 10) unit-dose tablets NDC-72205-027-06 Rosuvastatin Tablets ,USP 10 mg are available as Pink, round shaped, biconvex, film coated tablets debossed with "R10" on one side and plain on other side. Bottle of 90 tablets NDC-72205-003-90 Bottle of 500 tablets NDC-72205-003-05 Bottle of 1000 tablets NDC-72205-003-99 Cartons of 100 (10 x 10) unit-dose tablets NDC-72205-003-06 Rosuvastatin Tablets,USP 20 mg are available as Pink, round shaped, biconvex, film coated tablets debossed with "R20" on one side and plain on other side. Bottle of 90 tablets NDC-72205-004-90 Bottle of 500 tablets NDC-72205-004-05 Bottle of 1000 tablets NDC-72205-004-99 Cartons of 100 (10 x 10) unit-dose tablets NDC-72205-004-06 Rosuvastatin Tablets, USP 40 mg are available as: Pink, oval shaped, biconvex, film coated tablets debossed with "R" on one side and "40" on other side. Bottle of 30 tablets NDC-72205-005-30 Bottle of 90 tablets NDC-72205-005-90 Bottle of 500 tablets NDC72205-005-05 Bottle of 1000 tablets NDC-72205-005-99 Cartons of 100 (10 x 10) unit-dose tablets NDC-72205-005-06 Storage Store at controlled room temperature, 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
Indications & Usage
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 has 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.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Rosuvastatin tablets can be taken with or without food, at any time of day. ( 2.1) Dose range: 5 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) 2.1 General Dosing Information The dose range for rosuvastatin tablets in adults is 5 to 40 mg orally once daily. The usual starting dose is 10 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 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 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 tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. 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. 2.3 Dosing in Asian Patients In Asian patients, consider initiation of rosuvastatin 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 ClinicalPharmacology (12.3) ]. 2.4 Use with Concomitant Therapy Patients taking cyclosporine The dose of rosuvastatin 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 tablets with gemfibrozil. If concomitant use cannot be avoided, initiate rosuvastatin calcium tablets at 5 mg once daily. The dose of rosuvastatin 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 tablets therapy with 5 mg once daily. The dose of rosuvastatin 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 < 30 mL/min/1.73 m 2 ) not on hemodialysis, dosing of rosuvastatin 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) ].