Finasteride 1mg Tablets

Description

Propecia (Finasteride 1mg) is a prescription medicine used to treat the symptoms of benign prostatic hyperplasia (BPH), male pattern hair loss (androgenic alopecia). Propecia may be used alone or with other medications. Propecia belongs to a class of drugs called 5-Alpha-Reductase Inhibitors. It is not known if Propecia is safe and effective in children. What are the possible side effects of Propecia? Propecia may cause serious side effects including: breast lumps, breast pain or tenderness, nipple discharge, and any other breast changes Get medical help right away, if you have any of the symptoms listed above. The most common side effects of Propecia include: loss of interest in sex, impotence, trouble having an orgasm, and abnormal ejaculation Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Propecia. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. DESCRIPTION PROPECIA (finasteride) tablets contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). PROPECIA® is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. PROPECIA is not indicated for use in women. DOSAGE AND ADMINISTRATION PROPECIA may be administered with or without meals. The recommended dose of PROPECIA 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. HOW SUPPLIED Dosage Forms And Handling PROPECIA tablets (1 mg) are tan, octagonal, film-coated convex tablets with “stylized P” logo on one side and PROPECIA on the other. Storage And Handling No. 6642 — PROPECIA tablets, 1 mg, are tan, octagonal, film-coated convex tablets with “stylized P” logo on one side and PROPECIA on the other. They are supplied as follows: NDC 0006-0071-31 bottles of 30 (with desiccant) NDC 0006-0071-54 PROPAK bottles of 90 (with desiccant). Storage And Handling Store at room temperature, 15-30°C (59-86°F). Keep container closed and protect from moisture. Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and Patient Counseling Information].