FINASTERIDE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Ascend Laboratories, LLC

INN (Nama Antarabangsa):

FINASTERIDE

Komposisi:

FINASTERIDE 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 acute urinary retention      -    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 is 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 females 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

Ringkasan produk:

Finasteride tablets, USP 5 mg are available as blue colored, 7 mm round, biconvex, film coated tablets, marked “F5” on one side and plain on other side. They are supplied as follows: NDC 67877-288-30, bottles of 30 tablets NDC 67877-288-90, bottles of 90 tablets NDC 67877-288-01, bottles of 100 tablets NDC 67877-288-05, bottles of 500 tablets  NDC 67877-288-10, bottles of 1000 tablets NDC 67877-288-33, Carton pack of 10 unit-dose tablets Storage and Handling    Store at room temperatures 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Females 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) and Use in Specific Populations (8.1)] .

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Ascend Laboratories, LLC
----------
Finasteride Tablets, USP
(fi na’ ste ride)
Patient Information about
Finasteride Tablets, USP
Finasteride tablets are for use by men only.
Please read this leaflet before you start taking finasteride tablets.
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 tablets when you start
taking your medication and at regular checkups.
What are finasteride tablets?
Finasteride tablets are a medication used to treat symptoms of benign
prostatic hyperplasia (BPH) in men
with an enlarged prostate. Finasteride tablets may also be used to
reduce the risk of the need for surgery
related to BPH in men with an enlarged prostate.
Finasteride tablets 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 tablets?
Finasteride tablets are for use by MEN only.
Do Not Take finasteride tablets if you are:
• a woman who is pregnant or may potentially be pregnant.
Finasteride tablets may harm your unborn
baby. Do not touch or handle crushed or broken finasteride tablets
(see "A warning about finasteride
tablets 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 tablets and pregnancy:
Women who are or may potentially be pregnant must not use finasteride
tablets. They should also not
handle crushed or broken tablets of finasteride tablets. 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 tablets after oral
use or through the skin, it may cause the male baby to be born with
abn

Ciri produk

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
ASCEND LABORATORIES, LLC
----------
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
INDICATIONS AND USAGE
Finasteride tablets, are 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 acute urinary retention
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 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).
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).
Females who are or may potentially be pregnant (4, 5.3, 8.1, 16).
WARNINGS AND PRECAUTIONS
Finasteride tablets reduces serum prostate specific antigen (PSA)
levels by approximately 50%.
However, any confirmed increase in PSA while on finasteride tablets
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 may increase the risk of high-grade prostate
cancer (5.2, 6.1).
Females should not handle crushed or broken finasteride tablets when
th