FINASTERIDE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Atlantic Biologicals Corps

INN (Международно Name):

FINASTERIDE

Композиция:

FINASTERIDE 5 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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: - 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 male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. In female rats, low doses of finasteride administered during pregnancy have prod

Каталог на резюме:

NDC:17856-0090-1 in a POUCH of 1 TABLET, FILM COATEDS

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
ATLANTIC BIOLOGICALS CORPS
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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
Improve symptoms
Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and prostatectomy.
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
: Finasteride is not approved for the prevention of prostate cancer (
).
LIMITATIONS OF USE1.3
DOSAGE AND ADMINISTRATION
Finasteride 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 ( , , , ). 45.48.116
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
Finasteride may increase the risk of high-grade prostate cancer ( , ).
5.26.1
Women should not handle crushed or broken finasteride tablets when
they are pregnant or may potentially be pregnant
due to potential risk to a male fetus ( ,