UROKA Dutasteride Soft Gelatin Capsules 0.5mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DUTASTERIDE

Boleh didapati daripada:

GoodScience Sdn. Bhd.

INN (Nama Antarabangsa):

DUTASTERIDE

Unit dalam pakej:

30 Capsules

Dikeluarkan oleh:

Mega Lifesciences Public Company Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
UROKA DUTASTERIDE SOFT GELATIN
CAPSULES 0.5MG
Dutasteride Soft Gelatin Capsules (0.5 mg)
WHAT IS IN THIS LEAFLET
1. What UROKA is used for
•
if you are allergic to dutasteride,
other 5-alpha reductase inhibitors,
UROKA should have their PSA
tested regularly.
2.
How UROKA works
or to any of the other ingredients
3.
Before you use UROKA
of this medicine.
• In a clinical study of men at
4.
How to use UROKA
•
if you have a severe liver disease.
increased risk of prostate cancer,
5.
While you are using UROKA
•
If you think any of these apply to
men taking UROKA had a serious
6.
Side effects
you, don’t take this medicine until
form of prostate cancer more often
7.
Storage and disposal of UROKA
you have checked with your
than men who did not take UROKA.
8.
Product description
doctor.
The effect of UROKA on this
9.
Manufacturer
serious form of prostate cancer is not
10. Product registration holder
_Pregnancy and Lactation_
clear.
WHAT UROKA IS USED FOR
UROKA is used to treat men with an
enlarged prostate (benign prostatic
hyperplasia) - a non-cancerous growth
of the prostate gland, caused by
producing too much of a hormone
called dihydrotestosterone.
HOW UROKA WORKS
The active ingredient is dutasteride. It
belongs to a group of medicines called
5-alpha reductase inhibitors.
As the prostate grows, it can lead to
urinary problems, such as difficulty in
passing urine and a need to go to the
toilet frequently. It can also cause the
flow of the urine to be slower and less
forceful. If left untreated, there is a
risk
that
your
urine
flow
will
be
completely
blocked
_(acute _
_urinary _
_retention)_
.
This
requires
immediate
medical treatment. In some situations,
surgery
is
necessary
to
remove
or
reduce the size of the prostate gland.
UROKA
lowers
the
production
of
dihydrotestosterone,
which
helps
to
shrink
the
prostate
and
relieve
the
symptoms. This will reduce the risk of
acute urinary retention and the need
for surgery.
UROKA may also be used with
another
medicine
ca

Ciri produk

(DUTASTERIDE SOFT GELATIN CAPSULES 0.5 MG)
COMPOSITION:
Each soft gelatin capsule contains dutasteride 0.5 mg
DESCRIPTION OF THE CAPSULE:
Colorless, oily liquid filled in 10 minim, oblong, opaque yellow, soft
gelatin capsule.
PHARMACODYNAMICS:
Pharmacotherapeutic group: testosterone-5-alpha-reductase inhibitors.
ATC code: G04C
B02.
Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by
inhibiting both
type 1 and type 2, 5
α
-reductase isoenzymes which are responsible for the conversion of
testosterone to 5
α
-DHT.
EFFECT ON 5 ALPHA-DIHYDROTESTOSTERONE AND TESTOSTERONE
Effect of daily doses of dutasteride on the reduction on DHT is dose
dependant and is
observed within 1-2 weeks (85% and 90% reduction, respectively).
In patients with BPH treated with dutasteride 0.5 mg/day, the median
decrease in serum
DHT was 94% at 1 year and 93% at 2 years and the median increase in
serum testosterone
was 19% at both 1 and 2 years.
EFFECT ON PROSTATE VOLUME:
Significant reductions in prostate volume have been detected as early
as one month after
initiation of treatment and reductions continued through Month 24
(p<0.001).
Dutasteride led to a mean reduction of total prostate volume of 23.6%
(from 54.9 ml at
baseline to 42.1 ml) at Month 12 compared with a mean reduction of
0.5% (from 54.0 ml
to 53.7 ml) in the placebo group. Significant (p<0.001) reductions
also occurred in prostate
transitional zone volume as early as one month continuing through
Month 24, with a
mean reduction in prostate transitional zone volume of 17.8% (from
26.8 ml at baseline
to 21.4 ml) in the dutasteride group compared to a mean increase of
7.9% (from 26.8ml
to 27.5 ml) in the placebo group at Month 12. The reduction of the
prostate volume seen
during the first 2 years of double-blind treatment was maintained
during an additional 2
years of open-label extension studies.
PHARMACOKINETICS:
ABSORPTION
Following oral administration of a single 0.5 mg dutasteride dose, the
time to peak serum
concentrations of dutasteride is 1 to 3 hours. Th