Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
RANBAXY (MALAYSIA) SDN. BHD.
ROSUVASTATIN CALCIUM
3x10tablet Tablets; 4x7tablet Tablets; 10x10tablet Tablets; 10x10tablet Tablets
RANBAXY (MALAYSIA) SDN. BHD.
1 _For the Use Only of a Registered Medical Practitioner _ PRESCRIBING INFORMATION XOLSTAT TABLETS (Rosuvastatin Calcium Tablets 5 mg / 10 mg / 20 mg) COMPOSITION XOLSTAT 5 MG Each film coated tablet contains Rosuvastatin Calcium equivalent to Rosuvastatin ………………. 5 mg XOLSTAT 10 MG Each film coated tablet contains Rosuvastatin Calcium equivalent to Rosuvastatin ………………. 10 mg XOLSTAT 20 MG Each film coated tablet contains Rosuvastatin Calcium equivalent to Rosuvastatin ………………. 20 mg EXCIPIENTS: XOLSTAT 5 MG tablets also contain: Lactose monohydrate, crospovidone, microcrystalline cellulose, sodium citrate, magnesium stearate, opadry yellow (hypromellose, titanium dioxide, polyethylene glycol / macrogol, yellow iron oxide). XOLSTAT 10 MG & 20 MG tablets also contain: Lactose monohydrate, crospovidone, microcrystalline cellulose, sodium citrate, magnesium stearate, opadry pink (hypromellose, titanium dioxide, polyethylene glycol / macrogol, red iron oxide). PRODUCT DESCRIPTION XOLSTAT 5 MG: Light yellow to yellow colored round film coated tablets with 'RT1' on one side and plain on the other side. XOLSTAT 10 MG: Light pink to pink colored round film coated tablets with 'RT2' on one side and plain on the other side. 2 XOLSTAT 20 MG: Light pink to pink colored round film coated tablets with 'RT3' on one side and plain on the other side. DESCRIPTION XOLSTAT tablets contain rosuvastatin calcium, which is a synthetic lipid-lowering agent for oral administration. 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. The chemical name for rosuvastatin calcium is bis[(_E_)-7-[4-(4-fluorophenyl)-6-isopropyl- 2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3_R_,5_S_)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: _ _ ROSUVASTATIN CALCIUM INDICATIONS Rosuvastatin is indicated as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of ele Baca dokumen lengkap