Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Rosuvastatin calcium
AstraZeneca Pty Ltd
Medicine Registered
VISACOR ® Product Information CV.000-463-679.8.0 1(27) VISACOR ® rosuvastatin calcium PRODUCT INFORMATION NAME OF THE MEDICINE The active ingredient in VISACOR ® is rosuvastatin, as rosuvastatin calcium. The chemical name 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. VISACOR, rosuvastatin calcium, is a HMG-CoA reductase inhibitor for the treatment of dyslipidaemia. The chemical structure of rosuvastatin calcium is: N N F N SO 2 Me O OH OH O 2 Ca 2+ CAS Number: 147098-20-2 Molecular formula: (C 22 H 27 FN 3 O 6 S) 2 Ca Molecular weight: 1001.14 DESCRIPTION Rosuvastatin calcium is an amorphous solid, which is slightly soluble in water (7.8 mg/mL at 37°C) and has a pKa of 4.6. Rosuvastatin calcium is the (3_R_,5_S_,6_E_) enantiomer. VISACOR film-coated tablets contain 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin (as calcium). The tablets also contain the following inactive ingredients: crospovidone, lactose, microcrystalline cellulose, calcium phosphate, magnesium stearate, glycerol triacetate, hypromellose and titanium dioxide. The 5 mg tablets also contain iron oxide yellow CI77492 whereas the 10 mg, 20 mg and 40 mg tablets contain iron oxide red CI77491. VISACOR ® Product Information CV.000-463-679.8.0 2(27) PHARMACOLOGY Rosuvastatin is a fully synthetic competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated, with apolipoprotein B (ApoB), into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. VLDL particles are TG-rich. Ch Les hele dokumentet