FINASTERIDE tablet film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Legacy Pharmaceutical Packaging, LLC

INN (Tên quốc tế):

FINASTERIDE

Thành phần:

FINASTERIDE 5 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
----------
FINASTERIDE - FINASTERIDE TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
HIGHLIGHT 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, 5 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
1 INDICATIONS AND USAGE
1.1 MONOTHERAPY
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.
1.2 COMBINATION WITH ALPHA-BLOCKER
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).
1.3 LIMITATIONS OF USE
Finasteride tablets USP are not approved for the prevention of
prostate cancer.
2 DOSAGE AND ADMINISTRATION
Finasteride tablets USP may be administered with or without meals.
2.1 MONOTHERAPY
The recommended dose of finasteride tablet USP is one tablet (5 mg)
taken once a day _[see Clinical_
Studies _(14.1)]._
2.2 COMBINATION WITH ALPHA-BLOCKER
The recommended dose of finasteride tablets USP is one tablet (5 mg)
taken once a day in combination
with the alpha-blocker doxazosin _[see Clinical Studies (14.2)]._
3 DOSAGE FORMS & STRENGTHS
Finasteride tablets USP, 5 mg are blue color, round film coated
tablets, debossed with 'H' on one side
'37' on other side.
4 CONTRAINDICATIONS
Finasteride tablets USP 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 conv