FINASTERIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets 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  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: - 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 pre

Product summary:

Finasteride Tablets USP, 5 mg are blue-colored, round, biconvex, film-coated tablets imprinted with "ZE 56" in black ink on one side and plain on other side and are supplied as follows: NDC 68382-074-06 in bottles of 30 tablets NDC 68382-074-01 in bottles of 100 tablets NDC 68382-074-10 in bottle of 1000 tablets NDC 68382-074-30 unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage and Handling: Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  Protect from light. Keep container tightly closed. Dispense in a tight, light-resistant container. 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)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
Zydus Pharmaceuticals USA Inc.
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Patient Information
Finasteride [fin-AS-tur-eyed] Tablets USP
Finasteride is for use by men only.
Please read this leaflet before you start taking finasteride. Also,
read it each time you renew your
prescription, just in case anything has changed. Remember, this
leaflet does not take the place of careful
discussions with your doctor. You and your doctor should discuss
finasteride when you start taking your
medication and at regular checkups.
What is finasteride?
Finasteride is a medication used to treat symptoms of benign prostatic
hyperplasia (BPH) in men with an
enlarged prostate. Finasteride may also be used to reduce the risk of
a sudden inability to pass urine and the
need for surgery related to BPH in men with an enlarged prostate.
Finasteride may be prescribed along with another medicine, an
alpha-blocker called doxazosin, to help you
better manage your BPH symptoms.
Who should NOT take finasteride?
Finasteride is for use by MEN only.
Do Not Take Finasteride if you are:
•
a woman who is pregnant or may potentially be pregnant. Finasteride
may harm your unborn baby.
Do not touch or handle crushed or broken finasteride tablets (see "A
warning about finasteride and
pregnancy").
•
allergic to finasteride or any of the ingredients in finasteride. See
the end of this leaflet for a complete
list of ingredients in finasteride.
A warning about finasteride and pregnancy:
Women who are or may potentially be pregnant must not use finasteride.
They should also not handle
crushed or broken tablets of finasteride. Finasteride tablets are
coated and will prevent contact with the active
ingredient during normal handling, provided that the tablets are not
broken or crushed.
If a woman who is pregnant with a male baby absorbs the active
ingredient in finasteride after oral use or
through the skin, it may cause the male baby to be born with
abnormalities of the sex organs. If a woman
who is pregnant comes into contact with the active i

Summary of Product characteristics

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
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, 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, are 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 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
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 pr