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 Pharmacetucals Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Finasteride tablets 5 mg administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). Finasteride is not approved for the prevention of prostate cancer. Finasteride is contraindicated in the following: Risk Summary Finasteride tablets are contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, finasteride may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [See Warnings and Precautions (5.3)and Clinical Pharmacology (12.1).] In an embryo-fetal development study in rats, there was a

Product summary:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Females should not handle crushed or broken finasteride tablets, USP 5mg 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 [see Warnings and Precautions (5.3), and Use in Specific Populations (8.1)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
PREFERRED PHARMACETUCALS 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, is a 5α-reductase inhibitor, indicated for the treatment
of symptomatic benign prostatic
hyperplasia (BPH) in men with an enlarged prostate to ( 1.1):
•
•
•
Finasteride administered in combination with the alpha-blocker
doxazosin is indicated to reduce the risk of
symptomatic progression of BPH (a confirmed ≥4 point increase in
American Urological Association (AUA)
symptom score) ( 1.2).
LIMITATIONS OF USE: Finasteride is not approved for the prevention of
prostate cancer ( 1.3).
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
5-mg film-coated tablets ( 3).
CONTRAINDICATIONS
Hypersensitivity to any components of this product ( 4).
Females who are or may potentially be pregnant ( 4, 5.3, 8.1, 16).
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The drug-related adverse reactions, reported in ≥1% in patients
treated with finasteride and greater than
in patients treated with placebo over a 4-year study are: impotence,
decreased libido, decreased volume
of ejaculate, breast enlargement, breast tenderness and rash ( 6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC.
AT 1866-941-
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: 6/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Monotherapy
1.2 Combination with Alpha-Blocker
1.3 Limitations of Use
2 DOSAGE AND ADMINISTRATION
Improve symptoms
Reduce the risk of acute urinary retention
Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and
prostatectomy.
Finasteride may be adm