Finasteride 5 MG Oral Tablet
1 INDICATIONS AND USAGE Finasteride tablets 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 tablets 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 is not approved for the prevention of prostate cancer (1.3) . 1.1 Monotherapy Finasteride tablets 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 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 are not approved for the prevention of prostate cancer.
Exelan Pharmaceuticals Inc.
ROUND BLUE IG 412
IG 412 ROUND BLUE
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Finasteride 5 MG Oral Tablet
Exelan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
FINASTERIDE tablets USP, 5 mg are blue color, film coated, round tablets debossed with ‘IG’ on one side ‘412’ on other. They are supplied as follows: NDC 76282-412-30 bottles of 30 NDC 76282-412-90 bottles of 90 NDC 76282-412-05 bottles of 500 NDC 76282-412-10 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. 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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