FINASTERIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hetero Drugs Limited

INN (Διεθνής Όνομα):

FINASTERIDE

Σύνθεση:

FINASTERIDE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Finasteride tablets USP are not approved for the prevention of prostate cancer.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FINASTERIDE - FINASTERIDE TABLET
HETERO DRUGS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INITIAL U.S. APPROVAL: 1992
RX ONLY
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, 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.
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).
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, 5.5, 8.1, 16).
WARNINGS AND PRECAUTIONS
• Finasteride tablets USP reduces serum prostate specific antigen
(PSA) levels by approximately 50%. However, any
confirmed increase in PSA while on finasteride tablets USP 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 tablets USP may increase the risk of high-grade
prostate cancer (5.2, 6.1).
• Prior to initiating therapy with finasteride tablets USP,
appropriate evaluation should be performed to rule out other
urological conditions, including prostate cancer, that might mimic BPH
(5.3, 12.3).
• Women should not handle crushed or broken