FINASTERIDE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Thirty Madison 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 (16) and Patient Counseling Information (17.1).] In female rats, low doses of finasteride

Vörulýsing:

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:  90's HDPE Container pack: NDC 71713-099-90  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 (17.1)]. 

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FINASTERIDE - FINASTERIDE TABLET
THIRTY MADISON 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
5αreductase 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). (6)
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. (6)
SEE 17 FOR PATIENT COUNSELING INFORMAT