Finasteride 5 MG Oral Tablet
1 INDICATIONS AND USAGE Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : Finasteride is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: -Improve symptoms -Reduce the risk of acute urinary retention -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 5 mg administered in combination with the alpha-blocker doxazosin is 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 is not approved for the prevention of prostate cancer.
Accord Healthcare, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
FINASTERIDE tablets, USP 5 mg : blue, 7 mm, round, biconvex, film coated tablets, marked 'F5' on one side and plain on other side. They are supplied as follows: NDC 16729-090-10 Bottles of 30 with child resistant closure NDC 16729-090-15 Bottles of 90 with child resistant closure NDC 16729-090-01 Bottles of 100 with child resistant closure NDC 16729-090-16 Bottles of 500 NDC 16729-090-17 Bottles of 1000 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Females should not handle crushed or broken
FINASTERIDE tablets, USP 5mg 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 [see Warnings and Precautions (5.3) , and Use in Specific Populations (8.1) ] .
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