Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)
AvKARE, Inc.
DUTASTERIDE
DUTASTERIDE 0.5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
DUTASTERIDE- DUTASTERIDE CAPSULE AVKARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION DUTASTERIDE CAPSULES THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DUTASTERIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUTASTERIDE CAPSULES. DUTASTERIDE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Dutasteride capsules is a 5 alpha-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, and reduce the risk of the need for BPH-related surgery. Dutasteride capsules in combination with the alpha adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2) Limitations of Use: Dutasteride capsules are not approved for the prevention of prostate cancer. (1.3) DOSAGE AND ADMINISTRATION Monotherapy: 0.5 mg once daily. (2.1) Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily. (2.2) Dosing considerations: Swallow whole. May take with or without food. (2) DOSAGE FORMS AND STRENGTHS 0.5 mg soft gelatin capsules (3) CONTRAINDICATIONS Pregnancy and women of childbearing potential. (4, 5.4, 8.1) Pediatric patients. (4) Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride, USP or other 5 alpha-reductase inhibitors. (4) WARNINGS AND PRECAUTIONS Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.1) Dutasteride may increase the risk of high-grade prostate cancer. (5.2, 6.1) Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause simi Olvassa el a teljes dokumentumot