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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 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 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.

Teva Pharmaceuticals USA, Inc.


11 months ago OVAL BLUE 93 7355 finasteride 5 MG Oral Tablet

OVAL BLUE 93 7355

11 months ago OVAL BLUE 93 7355 finasteride 5 MG Oral Tablet

93 7355 OVAL BLUE

16 HOW SUPPLIED/STORAGE AND HANDLING

FINASTERIDE Tablets USP, 5 mg are available as blue, film-coated, capsule-shaped, unscored tablets, debossed “93” on one side and “7355” on the other side, in bottles of 30, 90, and 500 tablets. NDC 0093-7355-56 bottle of 30. NDC 0093-7355-98 bottle of 90. NDC 0093-7355-05 bottle of 500. Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. Females 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, USP and the subsequent potential risk to a male fetus [see Warnings and Precautions ( 5.3 ), and Use in Specific Populations ( 8.1 )] . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


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