Drug Catalog - Product Detail
FINASTERIDE TB 1MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65862-0927-30 | AUROBINDO PHARMA | 30 | 1MG | TABLET |
PACKAGE FILES
Generic Name
FINASTERIDE
Substance Name
FINASTERIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203687
Description
11 DESCRIPTION Finasteride tablets USP contain finasteride USP 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). The chemical name of finasteride is N-tert -Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. The molecular formula of finasteride 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 to off-white, crystalline solid with a melting point between 254°C and 262°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 USP and the following inactive ingredients: docusate sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch (maize), sodium starch glycolate, talc, and titanium dioxide. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Finasteride Tablets USP, 1 m g are white colored, octagonal, biconvex, film-coated tablets debossed with ‘J’ on one side and ‘81’ on the other side. Bottles of 30 NDC 65862-927-30 Bottles of 90 NDC 65862-927-90 Bottles of 1,000 NDC 65862-927-99 Storage and Handling Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. 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) ] .
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) .