País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Cipla USA Inc.
FINASTERIDE
FINASTERIDE 1 mg
ORAL
PRESCRIPTION DRUG
Finasteride tablet, USP is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablet, USP is not indicated for use in women. Finasteride tablet is contraindicated in the following: - Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5 α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See Warnings and Precautions (5.1), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (1
Finasteride tablets, USP are reddish brown, circular, biconvex, film coated tablets, debossed with 'C' on one side and '112' on other side Finasteride tablets, USP are available in bottles of 30 tablets (NDC 69097-112-02) bottles of 90 tablets (NDC 69097-112-05). Storage and Handling Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Keep container closed and protect from light and moisture. Women should not handle crushed or broken Finasteride tablets 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. Finasteride tablets1mg are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [see Warnings and Precautions (5.1), Use in Specific Populations (8.1) and Patient Counseling Information (17.1) ].
Abbreviated New Drug Application
FINASTERIDE- FINASTERIDE TABLET CIPLA USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 tablet, USP is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) inMEN ONLY (1). Finasteride tablet, USP is not indicated for use in women (1, 4, 5.1). DOSAGE AND ADMINISTRATION Finasteride tablets, USP may be administered with or without meals (2). One tablet (1 mg) taken once daily (2). In general, daily use for three months or more is necessary before benefit is observed (2). DOSAGE FORMS AND STRENGTHS 1 mg tablets (3). CONTRAINDICATIONS Pregnancy (4, 5.1,8.1, 16). Hypersensitivity to any components of this product (4). WARNINGS AND PRECAUTIONS Finasteride tablet is not indicated for use in women or pediatric patients (5.1, 5.4). Women should not handle crushed or broken Finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.1, 8.1,16). Finasteride tablet causes a decrease in serum PSA levels. 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 (5.2). 5 α -reductase inhibitors may increase the risk of high-grade prostate cancer (5.3,6.1). ADVERSE REACTIONS The most common adverse reactions, reported in ≥1% of patients treated with Finasteride tablets and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LIMITED, INDIA AT 1- 866 -604 -3268 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR Leer el documento completo