Arite Beclometasone 50mcgactuation Metered Dose Inhaler

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Beclometasone dipropionate

Boleh didapati daripada:

KOTRA PHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

Beclometasone dipropionate

Unit dalam pakej:

200 ACTUATIONS

Dikeluarkan oleh:

KOTRA PHARMA (M) SDN. BHD.

Risalah maklumat

ARITE BECLOMETASONE
50MCG/ACTUATION METERED DOSE
INHALER
Beclometasone Dipropionate 50mcg
1
_CUSTOMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Arite
Beclometasone
50mcg/actuation
Metered
Dose
Inhaler is used for.
2.
How
Arite
Beclometasone
50mcg/actuation
Metered
Dose
Inhaler works.
3.
Before
you
use
Arite
Beclometasone
50mcg/actuation
Metered Dose Inhaler.
4.
How to use Arite Beclometasone
50mcg/actuation
Metered
Dose
Inhaler.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Arite
Beclometasone
50mcg/actuation
Metered Dose Inhaler.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
ARITE
BECLOMETASONE
50MCG/ACTUATION
METERED
DOSE
INHALER IS USED FOR
Arite
Beclometasone
50mcg
/actuation
Metered
Dose
Inhaler
is
used for prevention of asthma.
HOW
ARITE
BECLOMETASONE
50MCG/ACTUATION
METERED
DOSE
INHALER WORK
Beclometasone
dipropionate
is
a
steroid medication used in the long-
term management of asthma, to make
breathing
easier
by
reducing
the
inflammation, swelling and irritation
to your lungs.
BEFORE
YOU
USE
ARITE
BECLOMETASONE
50MCG/ACTUATION
METERED DOSE INHALER
−
_When you must not use it _
Do
not
use
Arite
Beclometasone
50mcg/actuation
Metered
Dose
Inhaler if:
•
You
are
allergic
to
beclometasone
dipropionate,
or
any of the ingredients.
•
You are suffering from a sudden
attack of breathlessness, as this
inhaler
is
only
used
as
a
“preventer”.
You
will
need
a
quick-acting
‘reliever’
inhaler
which
contains
a
different
medicine
for
this
purpose
and
carry it with you at all times.
−
_Before you start to use it _
You need to tell your doctor if:
•
You
are
allergic
to
any
medicines.
•
You
are
taking
any
other
medicines
(including
those
not
prescribed by your doctor).
•
You
are
pregnant
or
nursing
babies.
Some
medicines
may
increase
the
effects
of
Arite
Beclometasone
50mcg/actuation
Metered
Dose
Inhaler and your doctor may wish to
monitor
you
carefully
if
you
are
taking
these
medicines
(including

Ciri produk

COMPOSITION:
Each actuation delivers:
Beclometasone Dipropionate 50 mcg
Ethanol 8% w/w
This product contains a propellant, which does
not contain any chlorofluorocarbons (CFCs).
PRESENTATION:
A colourless solution in a pressurized aluminium
canister fitted with a metering valve and actuator,
and with propellant which is CFC free.
INDICATION:
For the prophylactic management of asthma.
PHARMACOLOGY:
_Mechanism of action:_
Arite Beclometasone 50mcg/actuation Metered
Dose
Inhaler
contains
beclometasone
dipropionate in solution in propellant HFA-134a
resulting in an extrafine aerosol. The aerosol
droplets are on average much smaller than the
beclometasone dipropionate particles delivered
by CFC suspension formulations or dry powder
formulations
of
beclometasone
dipropionate.
Inhaled beclometasone dipropionate is now well
established in the management of asthma. It is a
synthetic
glucocorticoid
and
exerts
a
topical,
anti-inflammatory effect on the lungs, with fewer
systemic
effects
than
oral
corticosteroids.
CFC-free beclometasone dipropionate aerosol
inhalers shown to exhibit equivalent therapeutic
effects,
pulmonary
function
and
control
of
symptoms at lower total daily doses than CFC
containing beclometasone dipropionate aerosol
inhalers.
_Pharmacokinetic:_
The pharmacokinetic profile shows that the peak
serum
concentration
for
total-beclometasone
(BOH)
(total
of
any
beclometasone
OH
and
beclometasone dipropionate or monopropionate
hydrolysed to beclometasone OH) or after single
and multiple doses is achieved after 30 minutes.
The value at the peak is approximately 2ng/ml
after a total daily dose of 800 mcg and the serum
levels
after
100,
200
and
400mcg
are
proportional. The principal route of elimination of
beclometasone
dipropionate
and
its
several
metabolites is in the faeces. Between 10% and
15% of an orally administered dose is excreted in the urine, as
both conjugated and free metabolites of the drug. Lower total daily
doses of CFC-free beclometasone dipropionate aerosol inhalers
has
shown
to
achieve
the
same
c