Finagen Tablet 5mg

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

FINASTERIDE

Saatavilla:

UNIMED SDN BHD

INN (Kansainvälinen yleisnimi):

FINASTERIDE

Kpl paketissa:

20tablet Tablets; 30 Tablets; 100 Tablets

Valmistaja:

Aurobindo Pharma Limited

Valmisteyhteenveto

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablets contains:
Finasteride Ph.Eur 5 mg
PHARMACEUTICAL FORM
Blue coloured, circular, biconvex, beveled edged film-
coated tablets debossed with 'E' on one side and '61' on the
other side.
PHARMACODYNAMIC PROPERTIES
Finasteride
is
a
competitive
inhibitor
of
human
5a
reductase,
an
intracellular
enzyme
which
metabolises
testosterone
into
the
more
potent
androgen,
dihydro-
testosterone (DHT). In benign prostatic hyperplasia (BPH),
enlargement of the prostate gland is dependent upon the
conversion of testosterone to DHT within the prostate.
Finasteride is highly effective in reducing circulating and
intraprostatic
DHT.
Finasteride
has
no
affinity
for
the
androgen receptor.
PHARMACOKINETIC PROPERTIES:
After an oral dose of 14C - Finasteride in man, 39 % of the
dose was excreted in the urine in the form of metabolites
(virtually no unchanged drug was excreted in the urine), and
57%
of
total
dose
was
excreted
in
the
faeces.
Two
metabolites have been identified which possess only a
small fraction of the Type II 5a -reductase activity of
finasteride.
The oral bioavailability of Finasteride is approximately
80 %, relative to an intravenous reference dose, and is
unaffected by food. Maximum plasma concentrations are
reached approximately two hours after dosing and the
absorption is complete within 6-8 hours.
Protein binding is approximately 93 %. Plasma clearance
and the volume of distribution are approximately 165 ml/min
and 76 L, respectively.
In
the
elderly,
the
elimination
rate
of
Finasteride
is
somewhat decreased. Half-life is prolonged from a mean
half-life of approximately six hours in men aged 18 - 60
years to eight hours in men aged more than 70 years.
This is of no clinical significance and does not want a
reduction in dosage.
In patients with chronic renal impairment, whose creatinine
clearance ranged from 9 - 55 ml/min, the disposition of a
single dose of "C - Finasteride was not different from that in
healthy volunteers. Protein binding also did not dif