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:

AvPAK

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed greater than or equal to 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 p

Product summary:

Finasteride Tablets, USP 5 mg are blue, round, biconvex film-coated tablets, with “F5” on one side and “ ” on the other. NDC 50268-323-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Storage and Handling Store at 20 to 25ºC (68 to 77ºF) with excursions permitted between 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature]. Protect from light. 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
AvPAK
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PATIENT INFORMATION ABOUT
FINASTERIDE (fin-AS-tur-eyed) TABLETS, USP 5 mg
Finasteride tablets, USP are 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
tablets. See the end of this leaflet for a
complete list of ingredients in finasteride tablets.
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 conta

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FINASTERIDE TABLETS, USP
RX ONLY
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
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 greater than or equal to 4 point
increase in American Urological Association (AUA)
symptom score) ( 1.2).
LIMITATIONS OF USE : Finasteride is 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 prostate cancer ( 5.2,
6.1).
Women should not handle crushed or broken finasteride tablets when
they are pregnant or may potentially b