FINASTERIDE- finasteride tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lake Erie Medical DBA Quality Care Products LLC

INN (Internationale Bezeichnung):

FINASTERIDE

Zusammensetzung:

FINASTERIDE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score). Finasteride tablets are not approved for the prevention of prostate cancer. Finasteride tablets are contraindicated in the following: [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 app

Produktbesonderheiten:

Finasteride Tablets, USP are available containing 5 mg of finasteride, USP. The 5 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and 151 on the other side. They are available as follows: 55700-508-30 55700-508-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription. 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 [see Warnings and Precautions (5.3), Use in Specific Populations (8.1) and Patient Counseling Information (17.2)].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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, USP 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 tablets administered in combination with the alpha-blocker
doxazosin are 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 are not approved for the
prevention of prostate cancer (1.3).
DOSAGE AND ADMINISTRATION
Finasteride tablets 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
•
•
•
•
•
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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Improve s