Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Unit Dose Services
FINASTERIDE
FINASTERIDE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FINASTERIDE - FINASTERIDE TABLET, FILM COATED UNIT DOSE SERVICES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FINASTERIDE TABLETS 5 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS 5 MG. FINASTERIDE TABLETS USP, 5 MG, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Finasteride tablets 5 mgare 5α-reductase inhibitors, 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 5 mgadministered 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) ( ). : Finasteride tablets 5 mg are not approved for the prevention of prostate cancer ( ). 1.2 LIMITATIONS OF USE1.3 DOSAGE AND ADMINISTRATION Finasteride tablets 5 mg may be administered with or without meals ( ). Monotherapy: One tablet (5 mg) taken once a day ( ). Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ( ). 2 2.1 2.2 DOSAGE FORMS AND STRENGTHS 5 mg film-coated tablets ( ). 3 CONTRAINDICATIONS Hypersensitivity to any components of this product ( ). Women who are or may potentially be pregnant ( , , , ). 4 45.48.116 WARNINGS AND PRECAUTIONS Finasteride tablets 5 mg reduce serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride tablets 5 mg may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor ( ). 5.1 Finasteride tablets 5 mg may increase the risk of high-grade prostate cancer ( , ). 5.26.1 Women should not handle crushed or broken finasteri Прочитайте повний документ