Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FINASTERIDE
UNIMED SDN BHD
FINASTERIDE
20tablet Tablets; 30 Tablets; 100 Tablets
Aurobindo Pharma Limited
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablets contains: Finasteride Ph.Eur 5 mg PHARMACEUTICAL FORM Blue coloured, circular, biconvex, beveled edged film- coated tablets debossed with 'E' on one side and '61' on the other side. PHARMACODYNAMIC PROPERTIES Finasteride is a competitive inhibitor of human 5a reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydro- testosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor. PHARMACOKINETIC PROPERTIES: After an oral dose of 14C - Finasteride in man, 39 % of the dose was excreted in the urine in the form of metabolites (virtually no unchanged drug was excreted in the urine), and 57% of total dose was excreted in the faeces. Two metabolites have been identified which possess only a small fraction of the Type II 5a -reductase activity of finasteride. The oral bioavailability of Finasteride is approximately 80 %, relative to an intravenous reference dose, and is unaffected by food. Maximum plasma concentrations are reached approximately two hours after dosing and the absorption is complete within 6-8 hours. Protein binding is approximately 93 %. Plasma clearance and the volume of distribution are approximately 165 ml/min and 76 L, respectively. In the elderly, the elimination rate of Finasteride is somewhat decreased. Half-life is prolonged from a mean half-life of approximately six hours in men aged 18 - 60 years to eight hours in men aged more than 70 years. This is of no clinical significance and does not want a reduction in dosage. In patients with chronic renal impairment, whose creatinine clearance ranged from 9 - 55 ml/min, the disposition of a single dose of "C - Finasteride was not different from that in healthy volunteers. Protein binding also did not dif Leggi il documento completo