Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
INDICATIONS [/za_1058.html#1] [/za_1058.html#1] [/za_1058.html#1] CONTRA-INDICATIONS [/za_1058.html#1] [/za_1058.html#1] DOSAGE [/za_1058.html#1] [/za_1058.html#1] SIDE-EFFECTS [/za_1058.html#1] [/za_1058.html#1] [/za_1058.html#1] PREGNANCY [/za_1058.html#1] [/za_1058.html#1] OVERDOSE [/za_1058.html#1] IDENTIFICATION [/za_1058.html#1] [/za_1058.html#1] PATIENT INFORMATION FINPRO (TABLETS) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): FINPRO (TABLETS) COMPOSITION: Each film-coated tablet contains FINASTERIDE 5 mg PHARMACOLOGICAL CLASSIFICATION A21.12 Hormone inhibitors PHARMACOLOGICAL ACTION Finasteride is a synthetic 4-azasteriod compound. Finasteride is an inhibitor of Type II 5-alpha reductase, an intracellular enzyme that metabolises testosterone into the more potent androgen dihydrotestosterone (DHT). Finasteride has no affinity for the androgen receptor. The development of the prostate gland and subsequent benign prostate hyperplasia (BHP) is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride reduces circulating and intraprostatic DHT. Within 24 hours after oral administration of finasteride there is a significant reduction in circulating DHT levels as a result of the inhibition of 5-alpha reductase. PHARMACOKINETICS Following an oral dose of 14 C-finasteride in humans, the bioavailability is approximately 80% (relative to an intravenous reference dose) and is not affected by food. Maximum finasteride plasma concentrations are reached about 2 hours after dosing and the absorption is complete after 6 to 8 hours. Protein binding is approximately 93%, plasma clearance about 165 mL/min and the volume of distribution, 76 litres. Finasteride displays a mean plasma elimination half-life of approximately 6 hours (4 - 12 h Read the complete document