FINASTERIDE- finasteride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 inhibi

Product summary:

Finasteride tablets, USP 1 mg: reddish brown, 7 mm, round, biconvex, film coated tablets, marked ‘F1’ on one side and plain on other side. They are supplied as follows: Bottle of 30 - 68788-9249-3 Bottle of 60 - 68788-9249-6 Bottle of 90 - 68788-9249-9 Storage and Handling Store at 20º to 25 ºC (68 º to 77 ºF) [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)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
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
•
•
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 ACCORD HEALTHCARE INC.
AT 1-866-941-7875 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
Finasteride 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. 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 inhib