FINASTERIDE- finasteride tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

AvKARE, Inc.

INN (mednarodno ime):

FINASTERIDE

Sestava:

FINASTERIDE 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 are contraindicated in the following: - Hypersensitivity to any component of this medication. - Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a mal

Povzetek izdelek:

Finasteride Tablets USP, 5 mg are available as blue, film-coated, capsule-shaped, unscored tablets, debossed “93” on one side and “7355” on the other side, available in the following: Bottles of 30        NDC 42291-280-30 Bottles of 90        NDC 42291-280-90 Bottles of 500      NDC 42291-280-50 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 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) ]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
FINASTERIDE TABLETS USP
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
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use ( 1.3) 06/2011
Warnings and Precautions
Increased Risk of High-Grade Prostate Cancer ( 5.2) 06/2011
INDICATIONS AND USAGE
Finasteride tablets USP, are a 5α-reductase inhibitor, indicated for
the treatment of symptomatic benign prostatic
hyperplasia (BPH) in men with an enlarged prostate to ( 1.1):
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) ( 1.2).
LIMITATIONS OF USE: Finasteride tablets USP are 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
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 be evaluated, even if those
values are still within the normal range for men not taking a
5α-reductase inhibitor ( 5.1).
Finas