FINASTERIDE tablet, coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Ascend Laboratories, LLC

INN (Tarptautinis Pavadinimas):

FINASTERIDE

Sudėtis:

FINASTERIDE 1 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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  ( 16 )  and  Patient   Counseling  Information  (17).]  In  female  rats,  low  doses

Produkto santrauka:

Finasteride tablets, USP 1 mg are available as reddish brown colored, 7 mm round, biconvex, film coated tablets, marked “F1” on one side and plain on other side. They are supplied as follows: 30’s HDPE Container pack: NDC 67877-455-30 90’s HDPE Container pack: NDC 67877-455-90 500’s HDPE Container pack: NDC 67877-455-05 Carton of 30 (3 x 10 unit-dose) Tablets: NDC 67877-455-94 Storage and Handling   Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Preserve in a tight, light-resistant container. 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, USP 1 mg 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)] .

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FINASTERIDE - FINASTERIDE TABLET, COATED
ASCEND LABORATORIES, LLC
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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).
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 17 FOR PATIENT COUNSELING IN