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:

Proficient Rx LP

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets USP, 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Finasteride tablets USP, 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: 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

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. Women should not handle crushed or broken finasteride tablets USP, 5 mg 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), Use in Specific Populations (8.1) and Patient Counseling Information (17.2)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE.
FINASTERIDE TABLETS USP, 5 MG, 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).
Women who are or may potentially be pregnant (4, 5.4, 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: 4/2022
Improve symptoms
Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and
prostatectomy.
Finasteride may be administered with or without meals ( 2 ).
Finasteride reduces serum prostate specific antigen (PSA) levels by
approximately 50%. However, any
confirmed increase in PSA while on Finasteride may signal the presence
of prostate cancer and
should b