FINASTERIDE- finasteride tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Finasteride (UNII: 57GNO57U7G) (Finasteride - UNII:57GNO57U7G)

Mevcut itibaren:

Preferred Pharmaceuticals, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Finasteride tablets 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 are not indicated for use in women. Finasteride is contraindicated in the following: Pregnancy Category X [see Contraindications (4) ]. Finasteride is contraindicated for use in women who are or may become pregnant. Finasteride 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, finasteride caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase i

Ürün özeti:

Finasteride tablets USP, 1 mg are beige, round, film-coated tablets embossed with “R” on one side and “171” on the other side and are supplied as Bottle of 30 - 68788-9517-3 Bottle of 60 - 68788-9517-6 Bottle of 90 - 68788-9517-9 Bottle of 100 - 68788-9517-1 Storage and Handling Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container closed and protect from 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 tablets 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) ].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FINASTERIDE.
FINASTERIDE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Increased Risk of High-Grade Prostate Cancer
with 5α-Reductase Inhibitors (5.3)
06/2011
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
1 mg tablets (3).
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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 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: 5/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
Finasteride tablet is a 5α-reductase inhibitor indicated for the
treatment of male pattern hair loss (androgenetic
alopecia) in MEN ONLY(1).
Finasteride tablets are not indicated for use in women (1, 4, 5.1).
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).
Pregnancy (4, 5.1, 8.1, 16).
Hypersensitivity to any components of this product (4).
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