País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Preferred Pharmaceuticals, Inc.
FINASTERIDE
FINASTERIDE 5 mg
ORAL
PRESCRIPTION DRUG
Finasteride tablets USP, are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: -Improve symptoms -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets USP 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). Finasteride tablets USP are not approved for the prevention of prostate cancer. Finasteride tablets USP are contraindicated in the following: Pregnancy Category X. [See Contraindications (4).] Finasteride tablets USP are contraindicated for use in women who are or may become pregnant. Finasteride tablets USP is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, f
Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other side. They are supplied as follows: Bottle of 30 - 68788-9519-3 Bottle of 60 - 68788-9519-6 Bottle of 90 - 68788-9519-9 Bottle of 100 - 68788-9519-1 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Women 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 and the subsequent potential risk to a male fetus [see Warnings and Precautions (5.3), Use in Specific Populations (8.1) and Patient Counseling Information (17.2)].
Abbreviated New Drug Application
FINASTERIDE- FINASTERIDE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FINASTERIDE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS USP. FINASTERIDE TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Finasteride tablets USP, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): 3. 4. Finasteride tablets USP 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 tablets USP is not approved for the prevention of prostate cancer (1.3). DOSAGE AND ADMINISTRATION Finasteride tablets USP 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 6. 7. 8. 9. 10. ADVERSE REACTIONS The drug-related adverse reactions, reported in ≥1% in patients treated with finasteride tablets USP and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY'S LABORATORIES INC. AT 1-888-375-3784 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 9/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Monotherapy 1.2 Leia o documento completo