FINASTERIDE - finasteride tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)

可用日期:

A-S Medication Solutions

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets USP are not indicated for use in women. Finasteride tablets USP are 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 5α-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 (17.1).] In female rats, low doses of fina

產品總結:

Product: 50090-2160 NDC: 50090-2160-0 90 TABLET, FILM COATED in a BOTTLE

授权状态:

Abbreviated New Drug Application

产品特点

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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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 are 5α-reductase inhibitors indicated for
the treatment of male pattern hair loss (androgenetic
alopecia) in MEN ONLY (1).
• Finasteride tablets USP are 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 tablets USP are not indicated for use in women or
pediatric patients (5.1, 5.4).
• Women should not handle crushed or broken finasteride tablets USP
when they are pregnant or may potentially be
pregnant due to potential risk to a male fetus (5.1, 8.1,16).
• Finasteride tablets USP causes a decrease in serum PSA levels. Any
confirmed increase in PSA while on finasteride
tablets USP 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).
• 5α-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 USP and greater than in
patients treated with placebo are: decreased libido, erectile
dysfunction and ejaculation disorder (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HETERO LABS LIMITED AT
866-495-1995 OR FDA AT 1-800-
F