Avacort HFA 200mcg Metered Dose Inhaler

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

BUDESONIDE

Disponible depuis:

Nano Medic Care Sdn. Bhd.

DCI (Dénomination commune internationale):

BUDESONIDE

Unités en paquet:

200units Units

Fabriqué par:

Synmosa Biopharma Corporation

Notice patient

Page 1 of 2 pages
_Consumer Medication Information Leaflet (RiMUP) _
AVACORT HFA 200MG METERED DOSE INHALER
Budesonide 200 mcg per puff
_ _
WHAT IS IN THIS LEAFLET:_ _
a)
What Avacort is used for
b)
How Avacort works
c)
Before you use Avacort
d)
How to use Avacort
e)
While you are using Avacort
f)
Side effects
g)
Preparing your Avacort Inhaler
h)
How to use your inhaler
i)
Storage and disposal of Avacort
j)
Product description
k)
Manufacturer
l)
Product Registration Holder
m)
Date of revision
WHAT AVACORT IS USED FOR:
The
name
of
your
medicine
is
Avacort HFA 200mcg Metered Dose
Inhaler
(called
‘Avacort’
in
this
leaflet). Avacort contains a medicine
called
Budesonide,
a
glucocorticosteroid, which is a type
of
steroid.
Each
puff
will
contain
200mcg of Budesonide.
HOW AVACORT WORKS:
Avacort
works
by
reducing
and
preventing swelling and inflammation
of the lungs.
BEFORE YOU USE AVACORT
WHEN YOU MUST NOT USE IT:
Do not take this
medicine and tell
your doctor if:

You are allergic (hypersensitive) to
Budesonide
or
any
of
the
other
ingredients of Avacort

You have tuberculosis (TB)

You have a cold or chest infection

You have liver problems
BEFORE YOU START TO USE IT:
Check with your doctor or pharmacist
before taking this medicine :

If you are pregnant or planning to
become pregnant.

If you are breast feeding.

If you have liver problems.

If
you
are
taking
any
steroid
medicines
TAKING OTHER MEDICINES:
Tell
your
doctor
about
all
the
medicines
you
take,
including
prescription and nonprescription
medicines,
vitamins,
and
herbal
supplements. Avacort and certain
other
medicines
may
interact
with
each other.
Especially tell your doctor if you are
taking:
-
Alcoholic drinks.
-
CYP3A4
Inhibitors,
e.g.
Ketoconazole and Itraconazole
-
Oestrogens
and
contraceptive
steroids
-
Steroids
HOW TO USE AVACORT
HOW MUCH TO USE?:
The usual dose given by your doctor
is one puff in the morning and one
puff in the evening. But this may be
be
increased
by
your
doctor,
depending on your conditions.
Hence,
always

Résumé des caractéristiques du produit

Page 1 of 3
COMPOSITION:
Each metered dose inhaler contains 200 doses of Budesonide 200mcg per
dose
PRODUCT DESCRIPTION:
Avacort HFA 200mcg Metered Dose Inhaler is a one-piece aluminum
pressurized containers, containing liquid product under pressure, with
no
foreign or unpleasant odor, administered via a 50 μl metering valve.
It contains 200 doses of 200 micrograms of budesonide per one metered
dose. It contains ethanol, polyethylene glycol and Propellant HFA134a.
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMIc PROPERTIES
ATC code : R03B A02
Budesonide is a glucocorticosteroid which possesses a high local anti-
inflammatory action, with a lower incidence and severity of adverse
effects
than those seen with oral corticosteroids.
PHARMACOKINETIC PROPERTIES
ABSORPTION:
Following oral inhalation via Avacort HFA 200mcg Metered Dose Inhaler,
peak plasma concentrations of budesonide (4.0 nmol/L after a dose of
800
μg) occur within 30 minutes. Maximum plasma concentration and area
under the plasma concentration time profile increase linearly with
dose, but
are slightly (20-30%) higher following repeated doses (3 weeks
treatment)
than after a single dose. Lung deposition is estimated to 34% ±10% of
the
metered dose (arithmetic mean ± SD), while 22% will be retained in
the
mouthpiece and the rest (approximately 45% of the metered dose) will
be
swallowed.
The
maximal
plasma
concentration
after
inhalation
of
1
milligram
budesonide is about 3.5 nmol/L and is reached after about 20 minutes.
DISTRIBUTION
Budesonide has a volume of distribution of approximately 3 L/kg.
Plasma
protein binding averages 85-90%.
METABOLISM:
Budesonide
undergoes
an
extensive
degree
(approximately
90%)
of
biotransformation on first passage through the liver to metabolites of
low
glucocorticosteroid activity. The glucocorticosteroid activity of the
major
metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is
less
than 1% of that of budesonide. The metabolism of budesonide is
primarily
mediated by CYP3A, a subfamily of cytochrome p450.
EXCR