Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Qualitest Pharmaceuticals
FINASTERIDE
FINASTERIDE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FINASTERIDE- FINASTERIDE TABLET, FILM COATED QUALITEST PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FINASTERIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS. FINASTERIDE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1992 RECENT MAJOR CHANGES Indications and Usage, Limitations of Use (1.3) 06/2011 Warnings and Precautions, Increased Risk of High-Grade Prostate Cancer (5.2) 06/2011 INDICATIONS AND USAGE Finasteride tablets are 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. Finasterid tablets administered in combination with the alpha-blocker doxazosin are 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 are not approved for the prevention of prostate cancer (1.3). DOSAGE AND ADMINISTRATION Finasteride tablets may be administered with or without meals (2). Monotherapy: One tablet (5 mg) taken once a day (2.1). Combination with doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin (2.2). DOSAGE FORMS AND STRENGTHS 5-mg film-coated tablets (3). CONTRAINDICATIONS Hypersensitivity to any components of this product (4). Women who are or may potentially be pregnant (4, 5.4, 8.1, 16). WARNINGS AND PRECAUTIONS Finasteride reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on Finasteride Tablets 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 may increase the risk of high-grad Đọc toàn bộ tài liệu