All About Propecia

A sexual function questionnaire was self-administered by patients participating in the 2 vertex baldness trials to detect more subtle changes in sexual function. At month 12, statistically significant differences were found in 3 of 4 domains (sexual interest, erections, and perception of sexual problems) when compared to placebo. However, no significant difference was seen in the question on overall satisfaction with sex life.

The adverse reactions profile for 547 patients who continued on finasteride for up to 24 months was similar to that observed in the 12-month controlled studies.

The following adverse experiences have been reported in postmarketing use: ejaculation disorder; breast tenderness and enlargement; hypersensitivity reactions including rash, pruritus, urticaria and swelling of the lips and face; and testicular pain.

Finasteride is also in use for the treatment of older men with BPH at 5 times the dosage recommended for male pattern hair loss. Additional adverse reactions that have been reported at the 5 mg dosage in men with BPH are: breast tenderness and enlargement, and hypersensitivity reactions, including lip swelling and rash. In the clinical studies with finasteride, the incidence of these events was not different from placebo.

Laboratory Tests: No difference in standard laboratory parameters was observed between patients treated with placebo or finasteride.

Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3200 men and is generally well tolerated. In 3 12-month, placebo-controlled, double-blind, multicenter studies of comparable design, the overall safety profiles of finasteride and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 1.7% of 945 men treated with finasteride and 2.1% of 934 men treated with placebo.

In these studies, the following drug-related adverse experiences were reported in ³ 1% of men treated with finasteride or placebo, respectively: decreased libido (1.8%, 1.3%), erectile dysfunction (1.3%, 0.7%) and ejaculation disorder (1.2%, 0.7%; primarily decreased volume of ejaculate:[0.8%, 0.4%]). Integrated analysis of clinical adverse experiences showed that during treatment with finasteride, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04).

Resolution of these adverse reactions occurred in men who discontinued therapy with finasteride and in 58% who continued therapy. In a separate study, the effect of finasteride on ejaculate volume was measured and was not different from that seen with placebo.

Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for 3 months without adverse reactions.

No specific treatment for overdosage with finasteride is recommended.