Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BISOPROLOL FUMARATE
MEDISPEC (M) SDN.BHD
BISOPROLOL FUMARATE
100tablet Tablets
UNISON LABORATORIES CO.LTD
1 BISLOC TABLET PACKAGE INSERT BRAND OR PRODUCT NAME _ _ Bisloc 2.5mg Tablet Bisloc 5mg Tablet NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Bisoprolol fumarate 2.5 mg equivalent to bisoprolol 2.5mg Bisoprolol fumarate 5mg equivalent to bisoprolol 5mg PRODUCT DESCRIPTION Bisloc 25mg Tablet White, heart-shaped, biconvex, film coated tablet with scored on one side and plain on the other Bisloc 5mg Tablet Light yellow, heart-shaped, biconvex, film coated tablet with scored on one side and plain on the other. PHARMACODYNAMICS 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 metabolised 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 2 INDICATION For 5mg Treatment of high blood pressure (hypertension) Treatment of coronary heart disease (angina pectoris) Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides For 2.5mg Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides RECOMMENDED DOSAGE _Treatment of hypertension or angina pectoris_ In all cases the dose regimen is adjusted individually by your doctor, in particular according to the pulse rate and therapeutic success. Baca dokumen lengkap