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.
OVAL BLUE 93 7355
93 7355 OVAL BLUE
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
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.
More pills like OVAL 93 7355