FINASTERIDE - finasteride tablet, film coated
Aurobindo Pharma Limited
1 INDICATIONS AND USAGE
1.1 Monotherapy
Finasteride tablets, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets, USP are administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ?4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride tablets, USP are not approved for the prevention of prostate cancer.
2 DOSAGE AND ADMINISTRATION
Finasteride tablets may be administered with or without meals.
2.1 Monotherapy
The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-Blocker
The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
3 DOSAGE FORMS AND STRENGTHS
5 mg: Blue colored, circular, biconvex, beveled edged film-coated tablets debossed with 'E" on one side and '61" on the other side.
PROPECIA - finasteride tablet, film coated
Physicians Total Care, Inc.
1 INDICATIONS AND USAGE
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.
2 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.
3 DOSAGE FORMS AND STRENGTHS
PROPECIA tablets (1 mg) are tan, octagonal, film-coated convex tablets with "stylized P" logo on one side and PROPECIA on the other.
