Apo-Tamsulosin CR Tablets 0.4 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TAMSULOSIN HYDROCHLORIDE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TAMSULOSIN HYDROCHLORIDE

Unit dalam pakej:

30tablet Tablets; 100tablet Tablets

Dikeluarkan oleh:

APOTEX INC

Risalah maklumat

APO-TAMSULOSIN CR TABLETS 0.4MG
Tamsulosin Hydrochloride 0.4mg
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Tamsulosin is used for
2.
How Apo-Tamsulosin works
3.
Before you use Apo-Tamsulosin
4.
How to use Apo-Tamsulosin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Tamsulosin
8.
Product Descriptio
n
9.
Manufacturer and Product
Reg
istration Hold
er
10
.
Date of revisi
on
WHA
T APO-TAMSULOSIN_ _IS USED FOR
Apo- Tamsulosin (tamsulosin
hydrochloride) is indicated for the
treatment of Lower Urinary Tract
Symptoms (LUTS) associated with
benign prostatic hyperplasia (BPH).
HOW APO-TAMSULOSIN_ _WORKS
Apo-Tamsulosin is an alpha-blocker that
relaxes the muscles in the prostate and
bladder neck, making it easier to urinate.
BEFORE YOU USE APO-TAMSULOSIN_ _
-
_When you must not use it_
D
o not use this product if you ar
e
allerg
ic to
_ _
tamsulosin or any othe
r
in
gredients in this medication (p
lease
refe
r to
PRODUCT DESCRIPTION
)
You also should not use Apo-
Tamsulosin if you are using certai
n
m
edication, such as concomitant
strong CYP3A4 inhibitors (e.g.
ket
oconazole)
_Pregnancy and lactation_
Ap
o-Tamsulosin (Tamsulosin
hydrochloride) is not indicated for
use
in women.
-
_Before you start to use it_
Bef
ore you start to use Apo-
Tamsulosin, you should inform your
doctor if you have any other
medication condition that requi
re
atten
tion.
-
_Taking other medicines_
C
ertain medication might cau
se
co
mplication when taken together with
Apo-Tamsulosin, which includes:
• Strong inhibitors of CYP3A4 (e.g
.
ket
oconazole)
• Moderate inhibitors of
CYP3A4 (e.g.
ery
thromycin
)
• Cimetidine
• Ot
her alpha adrenergic blocking
agent
• Warfarin
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE APO-TAMSULOSIN_ _
-
_How much to use_
Ap
o-Tamsulosin 0.4 mg once daily is
recommended as
the dose for the
treat
ment of lower urin
ary tr

Ciri produk

APO‐TAMSULOSIN CR TABLETS 0.4MG
Tamsulosin Hydrochloride 0.4mg
PRODUCT DESCRIPTION
Yellowish‐brown, round, biconvex film‐coated tablet. Engraved
“TA”
over “0.4” on one side, plain on the other side.
PHARMACODYNAMICS
MECHANISM OF ACTION
Tamsulosin binds selectively and competitively to postsynaptic α
1
‐
receptors,
in
particular
to
the
subtype
α
1A
,
which
bring
about
relaxation of the smooth muscle of the prostate, whereby tension is
reduced.
_Pharmacodynamic:_
Tamsulosin increases maximum urinary flow rate by reducing smooth
muscle
tension
in
the
prostate
and
urethra
thereby,
relieving
obstruction.
It also improves the complex of irritative and obstructive symptoms
in which bladder instability and tension of the smooth muscles of the
lower urinary tract play an important role. α
1
‐blockers can reduce
blood pressure by lowering peripheral resistance. No reduction in
blood
pressure
of
any
clinical
significance
was
observed
during
studies with Tamsulosin.
_Paediatric Population: _No dose response was observed for any dose
level.
PHARMACOKINETICS
_Absorption: _Tamsulosin is a controlled‐release tablet and is
absorbed
from the intestine. Under fasting conditions, approximately 57% of
the administered dose is estimated to be absorbed. A consistent
control release of tamsulosin is maintained over the whole pH range
encountered in the gastrointestinal tract with little fluctuation over
24 hrs. The extent of absorption is increased by 64% and 149% [area
under
the
concentration‐time
curve
(AUC)
and
peak
plasma
concentration (C
max
)].
Tamsulosin shows linear kinetics.
After a single dose of Tamsulosin in the fasted state, plasma levels
of
tamsulosin peak at a median time of 6 hrs. In steady state, which is
reached by day 4 of multiple dosing, plasma levels of tamsulosin peak
at 4‐6 hrs in the fasted and fed state. Peak plasma levels increase
from approximately 6 ng/mL after the 1st dose to 11 ng/mL in steady
state.
As a result of the prolonged release characteristics of Tamsulosin
controlled‐