Becloten® Inhaler 100mcg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Beclometasone dipropionate

Boleh didapati daripada:

TENANG PHARMA SDN. BHD.

INN (Nama Antarabangsa):

Beclometasone dipropionate

Unit dalam pakej:

1 (200 actuations) Units

Dikeluarkan oleh:

TENANG PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
BECLOTEN
® INHALER 100MCG
_Beclometasone dipropionate (100mcg/actuation) _
_______________________________________________________________________________________________________________
_ _
WHAT IS IN THIS LEAFLET
1)
What Becloten
®
Inhaler is
used for
2)
How Becloten
®
Inhaler
works
3)
Before you use Becloten
®
Inhaler
4)
How to use Becloten
®
Inhaler
5)
While you are using it
6)
Side Effects
7)
Storage and Disposal of
Becloten
®
Inhaler
8)
Product Description
9)
Manufacturer and Product
Registration Holder
10)
Date of Revision
WHAT BECLOTEN
® INHALER IS USED
FOR
Becloten
®
Inhaler
contains
_beclometasone _
_dipropionate,_
which
is
one
of
a
group
of
medicines
known
as
glucocorticoid. Becloten
®
Inhaler
is
used
in
the
prophylactic
management of asthma.
HOW BECLOTEN
® INHALER WORKS
The anti-inflammatory effect of
_beclometasone _
_dipropionate_
plays
an
important
role
in
the
efficacy
of
_beclometasone _
_dipropionate_
in
controlling
symptoms
and
improving
lung
function
in
asthma.
It
is
a
pressurised metered-dose spray is
for
oral
inhalation
use
only.
Becloten
®
inhaler is not indicated
for the immediate relief of asthma
attacks.
BEFORE
YOU
USE
BECLOTEN
®
INHALER
-
_When you must not use it _
Do not use Becloten
®
Inhaler if
you are allergic (hypersensitive)
to:
a)
_Beclometasone dipropionate_
b)
any of the other ingredients of
Becloten
®
Inhaler.
Do not use Becloten
®
Inhaler if
any of the above apply to you. If
you
are not
sure,
talk to
your
doctor, nurse or pharmacist before
using Becloten
®
Inhaler.
_- Before you start to use it _
Check with your doctor, nurse or
pharmacist before taking your
medicine if:
a)
you are suffering from active
or
latent
pulmonary
tuberculosis.
b)
your
asthma
seems
to
be
getting
worse.
Perhaps
you
are feeling wheezy and short
of
breath
than
usual,
your
‘reliever’ inhaler seems to be
less
effective,
you
require
more
puffs
from
your
‘reliever’ inhaler than usual,
or
you
do not seem to be
getting
better.
Your
doc

Ciri produk

_ _
_For Medical Professional Use Only _
_ _
BECLOTEN
® INHALER 100MCG
_Beclometasone dipropionate _
_pressurised metered-dose inhaler/solution _
DESCRIPTION
A pressurised metered-dose inhaler containing not less than 200
actuations of
_beclometasone dipropionate_
clear solution filled in a 19 ml aluminium canister
fitted with a 50-microliter plastic and elastomeric metering valve
with a white polypropylene actuator and a light brown polypropylene
dust cap and packed into
individual printed carton. Each actuation delivers 100 microgram
_ beclometasone dipropionate. _
PHARMACODYNAMICS
_Beclometasone dipropionate_
is a pro-drug with weak glucocorticoid receptor binding affinity. It
is hydrolyzed via esterase enzymes to an active metabolite
_beclometasone-17-monopropionate_
which has higher topical anti-inflammatory activity compared with
_beclometasone dipropionate_
. The
_in vitro_
study shows
that,
_beclometasone 17-monopropionate _
exhibits affinity for the human glucocorticoid receptor is 13 times
that of
_dexamethasone_
, 6 times that of
_triamcinolone _
_acetonite,_
1.5 times that of
_budesonide_
, and 25 times that of parent compound.
Inflammation is an important component in the pathogenesis of asthma.
The wide range of inhibitory activities against multiple cell types
(mast cells,
eosinophils, neutrophils, macrophages and lymphocytes) and mediators
(histamine, eicosanoids, leukotrienes and cytokines) involved in
allergic and non-
allergic-mediated inflammation may contribute to their efficacy in
asthma.
PHARMACOKINETICS
_Absorption:_
Following inhalation, systemic absorption of
_beclomethasone dipropionate_
occurs through the lung with negligible oral absorption of the
swallowed dose. Prior
to absorption within the lung, there is an extensive conversion of
_beclometasone propionate,_
to its active metabolite,
_beclometasone 17-monopropionate._
The
systemic absorption of
_beclometasone 17-monopropionate_
arises from lung deposition and oral absorption is 36 and 26%
respectively. Following inhalation of
the