finasteride 5 MG Oral Tablet
1 INDICATIONS & USAGE Finasteride tablets USP, 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 the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets USP 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 tablets USP is not approved for the prevention of prostate cancer ( 1.3 ). 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 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 tablets USP are not approved for the prevention of prostate cancer.
Camber Pharmaceuticals, Inc.
ROUND BLUE H 37
H 37 ROUND BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING
FINASTERIDE tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other sideon other side. They are supplied as follows: NDC 31722-525-30 30s count NDC 31722-525-01 100s count NDC 31722-525-10 1000s count NDC 31722-525-90 90s count NDC 31722-525-05 500s count 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. Women should not handle crushed or broken
FINASTERIDE tablets USP 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) , Use in Specific Populations (8.1) and Patient Counseling Information (17.2) ].
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