FINASTERIDE tablet, coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in  MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets is not indicated for use in women. Finasteride tablets 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 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 

Vörulýsing:

NDC 68071-2620-9 BOTTLES OF 90

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FINASTERIDE- FINASTERIDE TABLET, COATED
NUCARE PHARMACEUTICALS,INC.
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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.
FINASTERIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride tablets is a 5α-reductase inhibitor indicated for the
treatment
of male pattern hair loss (androgenetic alopecia) in MEN ONLY( 1).
Finasteride tablets is 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). (3)
CONTRAINDICATIONS
Pregnancy (4, 5.1, 8.1, 16).
Hypersensitivity to any components of this product (4).
WARNINGS AND PRECAUTIONS
Finasteride tablets 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 tablets 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 ).
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
and greater than in patients treated with placebo are: decreased
libido, erectile dysfunction
and ejaculation disorder ( 6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASCEND LABORATORIES,
LLC AT 1-877-ASC-
RX01 (877-272-7901) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE