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Author: Admin | 2025-04-28
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 (C22H27FN3O6S)2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulpboxide, acetonitrile and acetone, slightly soluble in water and methanol. 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, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. In addition to these, the rosuvastatin calcium tablets 5 mg also contain FD&C Yellow No. 5. Uses for Rosuvastatin Calcium TabletsPediatric use information for patients 7 to 17 years ofage is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets.However, due to AstraZeneca's marketing exclusivity rights, this drug productis not labeled with that pediatric information.HypertriglyceridemiaRosuvastatin calcium tablets are indicated as adjunctivetherapy to diet for the treatment of adult patients with hypertriglyceridemia.Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)Rosuvastatin calcium tablets are indicated as an adjunctto diet for the treatment of adult patients with primary dysbetalipoproteinemia(Type III Hyperlipoproteinemia).Adult Patients With Homozygous Familial Hypercholes terolemiaRosuvastatin calcium tablets are indicated as adjunctivetherapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone ifsuch treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adultpatients with homozygous familial hypercholesterolemia.Limitations of UseRosuvastatin calcium tablets have not been studied inFredrickson Type I and V dyslipidemias. Dosage for Rosuvastatin Calcium TabletsGeneral Dosing InformationThe dose range for rosuvastatin calcium tablets in adultsis 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg oncedaily. The usual starting dose in adult patients with homozygous familial hypercholesterolemiais 20 mg once daily.The maximum rosuvastatin dose of 40 mg should be usedonly for those patients who have not achieved their LDL-C goal utilizing the 20mg dose [see WARNINGS AND PRECAUTIONS].Rosuvastatin calcium tablets can be administered as asingle dose at any
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