FINASTERIDE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Unit Dose Services

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 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 finaste

Каталог на резюме:

Product: 50436-0927 NDC: 50436-0927-1 30 TABLET, FILM COATED in a BOTTLE NDC: 50436-0927-3 90 TABLET, FILM COATED in a BOTTLE

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
UNIT DOSE SERVICES
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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 USP.
FINASTERIDE TABLETS USP, 1 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride is a 5α-reductase inhibitor 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 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 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 causes a decrease in serum PSA levels. Any confirmed
increase in PSA while on finasteride 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 and greater than in patients
treated with placebo are: decreased libido, erectile dysfunction and
ejaculation disorder (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA,
INC. AT 1-866-850-2876 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABEL