FINASTERIDE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Physicians Total Care, Inc.

INN (Alþjóðlegt nafn):

FINASTERIDE

Samsetning:

FINASTERIDE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Finasteride is 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 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 DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (See also WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS and PRECAUTIONS, Information for Patients and Pregnancy .) In female rats, low dos

Vörulýsing:

Finasteride Tablets, USP 5 mg are blue, round, film-coated tablets, with “F5” on one side and    on the other.Available in: Store at 20 to 25°C (68 to 77°F) with excursions permitted between 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed. 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 the male fetus (see CONTRAINDICATIONS ; WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS ; PRECAUTIONS, Pregnancy and HOW SUPPLIED ). Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with finasteride. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with finasteride (see ADVERSE REACTIONS ). Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported (see ADVERSE REACTIONS ). Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding finasteride. Manufactured by: INTAS PHARMACEUTICALS LTD. Plot No. 457, 458 Sarkhej-Bavla Highway Matoda-382 210 Gujarat, India Distributed by: Actavis Totowa 990 Riverview Drive Totowa, NJ 07512 USA 8569-01 01/07 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FINASTERIDE - FINASTERIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Finasteride, a synthetic 4-azasteroid compound, is a specific
inhibitor of steroid Type II 5α-reductase,
an intracellular enzyme that converts the androgen testosterone into
5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide,
_N_-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The
empirical formula of finasteride is C
H N O and its molecular weight is 372.55. Its structural
formula is:
Finasteride is a white crystalline powder with a melting point near
250°C. It is freely soluble in
chloroform and in lower alcohol solvents, but is practically insoluble
in water.
Finasteride tablets for oral administration are film-coated tablets
that contain 5 mg of finasteride and the
following inactive ingredients: FD&C Blue #2 Aluminum Lake,
hypromellose, lactose monohydrate,
lauryl macrogolglycerides, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
pregelatinized starch, sodium starch glycolate and titanium dioxide.
CLINICAL PHARMACOLOGY
The development and enlargement of the prostate gland is dependent on
the potent androgen, 5 α -
dihydrotestosterone (DHT). Type II 5 α −reductase metabolizes
testosterone to DHT in the prostate
gland, liver and skin. DHT induces androgenic effects by binding to
androgen receptors in the cell
nuclei of these organs.
Finasteride is a competitive and specific inhibitor of Type II
5α-reductase with which it slowly forms a
stable enzyme complex. Turnover from this complex is extremely slow (t
~30 days). This has been
demonstrated both _in vivo _and _in vitro. _Finasteride has no
affinity for the androgen receptor. In man, the 5
α -reduced steroid metabolites in blood and urine are decreased after
administration of finasteride.
In man, a single 5-mg oral dose of finasteride produces a rapid
reduction in serum DHT concentration,
with the maximum effect observed 8 hours after the first dose. The
suppression of DHT is maintained
throughout the 24-hour dosi