Drug Catalog - Product Detail
FINASTERIDE 1MG TABLETS 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45963-0600-09 | ACTAVIS | 90 | 1MG | TABLET |
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Description
11 DESCRIPTION Finasteride tablets, USP contain finasteride, USP as the active ingredient. Finasteride, USP 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). The chemical name of finasteride is N-tert -Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. The molecular formula of finasteride, USP is C 23 H 36 N 2 O 2 and its molecular weight is 372.55. Its structural formula is: Finasteride, USP is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water. Finasteride tablets, USP are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, lauroyl macrogolglycerides, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, pregelatinized starch (maize), sodium starch glycolate (Type A), and titanium dioxide. bf613562-figure-02
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Finasteride Tablets USP, 1 mg are reddish brown, round biconvex, film-coated tablets, marked ‘F1’ on one side and “ ” on the other side. Available in bottles of 30’s (NDC 45963-600-03), 90’s (NDC 45963-600-09). Storage and Handling Store at 20-25ºC (68-77ºF) with excursions permitted between 15-30ºC (59-86ºF). Keep container closed and protect from moisture . Women should not handle crushed or broken finasteride 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. Finasteride 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 (5.1) , Use in Specific Populations (8.1) and Patient Counseling Information (17.1) ]. imprint.JPG
Indications & Usage
1 INDICATIONS AND USAGE 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 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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 ( 2 ). One tablet (1 mg) taken once daily ( 2 ). In general, daily use for three months or more is necessary before benefit is observed ( 2 ).