ECE Pharma


AAA Pharma
Full Prescribing Info
Each film-coated tablet contains Finasteride Tablets USP 5 mg.
Pharmacology: Pharmacodynamics: Mechanism of Action: It is specific inhibitor of 5α-reductase, an intracellular enzyme that converts testosterone into the highly potent 5α-dihydrotestosterone which appears to be the principal androgen responsible for stimulation of prostate growth.
Onset of Action: Effects may be seen after a few months.
Duration of Action: Terminal elimination half life 4.8-6 hours.
Pharmacokinetics: Finasteride is adsorbed following oral administration and peak plasma concentrations are achieved in 1 to 2 hours. The mean bioavailability has variously been reported as 63% and 80%. It is about 90% bound to plasma protein. Finasteride is metabolized in the liver and excreted in urine and faeces as metabolites. The mean terminal half-life is about 6 hours in patients under 60 years of age but may be prolonged to about 8 hours in those 70 years of age or older.
Treatment of symptomatic benign hyperplasia.
Dosage/Direction for Use
Finasteride is an azasteriod that inhibits the type-2 isoform of 5α-reductase, the enzyme responsible for conversion of testosterone to the more active dihydrotestosterone, and therefore has anti-andregenic properties. It is given by mouth in a dose of 5 mg daily in the management of benign prostatic hyperplasia to cause regression of the enlarged prostate and to improve symptoms: it may be delayed and treatment for 6 months or more may be required to assess whether benefits has been achieved.
Or as prescribed by the physician.
Special Precautions
Hepatic dysfunction, patients with large residual urine volume. Increase in PSA level.
Adverse Reactions
Decreased libido, breast tenderness, impotence and hypersensitivity reactions.
Drug Interactions
Theophylline: Increased theophyline clearance and decrease its half-life.
Store at temperatures not exceeding 30°C.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04CB01 - finasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
Tab 5 mg (brick red colored, round shaped, biconvex with break line on one side) x 30's.
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