Finasteride

Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women. Finasteride is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1) . Finasteride tablets are not indicated for use in women ( 1 , 4 , 5.1 ).

• Finasteride tablets may be administered with or without meals
• The recommended dose of finasteride is one tablet (1 mg) taken once daily
• In general, daily use for three months or more is necessary before benefit is observed
• Continued use is recommended to sustain benefit, which should be re-evaluated periodically
• Withdrawal of treatment leads to reversal of effect within 12 months
• Finasteride tablets may be administered with or without meals
• One tablet (1 mg) taken once daily
• In general, daily use for three months or more is necessary before benefit is observed

Finasteride tablets (1 mg) are white colored, octagonal, biconvex, film-coated tablets debossed with ‘J’ on one side and ‘81’ on the other side. 1 mg tablets (3) .

• Finasteride is not indicated for use
• In pediatric patients
• Safety and effectiveness
• In pediatric patients have not been established

Clinical efficacy studies with finasteride did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for finasteride [see Clinical Pharmacology (12.3) ] . However the efficacy of finasteride in the elderly has not been established.

• Advise the patient to read the FDA-approved patient labeling ( Patient Information )
• Exposure of Women — Risk to Male Fetus Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus
• Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. …

• Finasteride tablets are contraindicated in the following: Pregnancy
• Finasteride use is contraindicated in women when they are or may potentially be pregnant
• Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. …

7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. …

Finasteride is not indicated for use in women or pediatric patients (5.1, 5.4) . Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.1, 8.1, 16) . Finasteride causes a decrease in serum PSA levels. Any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.2) . 5α-reductase inhibitors may increase the risk of high-grade prostate cancer (5.3, 6.1) . …

The most common adverse reactions, reported in ≥1% of patients treated with finasteride and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …

8.1 Pregnancy Pregnancy Category X [see Contraindications (4) ] . Finasteride is contraindicated for use in women who are or may become pregnant. Finasteride is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses. …

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m 2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m 2 (400 mg/kg) and 5900 mg/m 2 (1000 mg/kg), respectively.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.