FINASTERIDE- finasteride tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Preferred Pharmaceuticals, Inc.

INN (International Name):

FINASTERIDE

Sammensætning:

FINASTERIDE 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Finasteride tablets USP, are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:   -Improve symptoms   -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets USP 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 tablets USP are not approved for the prevention of prostate cancer. Finasteride tablets USP are contraindicated in the following: Pregnancy Category X. [See Contraindications (4).] Finasteride tablets USP are contraindicated for use in women who are or may become pregnant. Finasteride tablets USP 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, f

Produkt oversigt:

Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other side. They are supplied as follows:    Bottle of 30 - 68788-9519-3 Bottle of 60 - 68788-9519-6 Bottle of 90 - 68788-9519-9 Bottle of 100 - 68788-9519-1 Storage and Handling 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 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)].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FINASTERIDE- FINASTERIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS
USP.
FINASTERIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride tablets USP, is a 5α-reductase inhibitor, indicated for
the treatment of symptomatic benign prostatic hyperplasia
(BPH) in men with an enlarged prostate to (1.1):
3.
4.
Finasteride tablets USP 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 tablets USP is not approved for the
prevention of prostate cancer (1.3).
DOSAGE AND ADMINISTRATION
Finasteride tablets USP may be administered with or without meals (2).
Monotherapy: One tablet (5 mg) taken once a day (2.1).
Combination with Doxazosin: One tablet (5 mg) taken once a day in
combination with the alpha-blocker doxazosin (2.2).
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
6.
7.
8.
9.
10.
ADVERSE REACTIONS
The drug-related adverse reactions, reported in ≥1% in patients
treated with finasteride tablets USP 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 DR. REDDY'S
LABORATORIES INC. AT 1-888-375-3784 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Monotherapy
1.2