Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BISOPROLOL FUMARATE
MEDISPEC (M) SDN.BHD
BISOPROLOL FUMARATE
100 Tablets
UNISON LABORATORIES CO.LTD
D:\WorkPD_2021/BISLOC 2.5-5 Orapan_Job Print: 18-06-21 Scale 100% Product Code No. Dimension Packaging Type Thickness Designed by: (PDM, PDC-M, PDC-A, PDO-M, PDO-A) Checked by: (PDM/ASPD) Approved by: PLC: (Date) LRA: (Date) Approved by: (MD (Only Pattern and Colors) ) IRA: (Date) QCC-PM: (Date) CUSTOMER/SALES DEPT.: (Date) FRONT 29.5 cm. 16.5 cm. BETA-ADRENERGIC BLOCKING AGENT Each film coated tablet contains: BISOPROLOL FUMARATE 2.5 MG BISOPROLOL FUMARATE 5 MG MECHANISM OF ACTION: _PHARMACOLOGY_ Bisoprolol fumarate, a cardioselective inhibitor of beta(1)-adrenoceptor, has no significant intrinsic sympathomimetic activity or membrane stabilizing activity in its therapeutic dosage. It also exhibits beta(2)-adrenoceptors inhibition and negative chronotropic effect. _PHARMACOKINETICS_ Absorption Bisoprolol is almost completely absorbed from the gastrointestinal tract and undergoes only minimal first-pass metabolism resulting in an oral bioavailability of about 90%. Peak plasma concentrations occur 2 to 4 hours after oral doses. Distribution Bisoprolol is about 30% bound to plasma proteins. Bisoprolol is moderately lipid-soluble. Metabolism It is metabolized in the liver. Elimination It has a plasma elimination half-life of 10 to 12 hours. It is excreted in urine, about 50% as unchanged drug and 50% as metabolites. INDICATION: For 2.5 mg: • Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides For 5 mg: • Treatment of high blood pressure (hypertension) • Treatment of coronary heart disease (angina pectoris) • Treatment of stable chronic heart failure with reduced systolic left v Baca dokumen lengkap