Duolin Metered Dose Inhaler

Country: Malaysia

Language: English

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

Active ingredient:

Ipratropium Bromide Monohydrate BP; Salbutamol sulphate BP (Micronised

Available from:

CIPLA MALAYSIA SDN BHD

INN (International Name):

Ipratropium Bromide Monohydrate BP; Salbutamol sulphate BP (Micronised

Units in package:

200 Units

Manufactured by:

CIPLA LTD

Patient Information leaflet

Breathe out gently,
through your mouth.
Remove the mouthpiece cover,
and check that it is clean.
Shake the inhaler well. Hold the
inhaler upright as shown, with
your thumb on the base. Place
either one or two fingers on top
of the canister.
Before using your inhaler for the
first time, or if it has not been
used for a week or more, shake
it well and then "test fire" it, i.e.
release one puff into the air.
TTesting
esting y
your
our i
inhaler
nhaler
1
2
HOW TO USE
YOUR INHALER CORRECTLY
3
4
5
Place the mouthpiece of the
inhaler in your mouth between
your teeth and close your lips
around it (Do not bite it). Tilt
your head slightly backwards.
Start breathing in slowly through
your mouth. As you breathe in,
press down the canister to
release one dose while
continuing to breathe in steadily
and deeply.
Remove the inhaler from your
mouth and hold your breath
for 10 seconds, or for as long
as it is comfortable. Breathe
out slowly.
If another dose is required, wait
for at least one minute and
repeat steps 2 to 4. After use,
replace the mouthpiece cover.
IMPOR
IMPORTTANT
ANT::
Do not rush steps 3 and 4. It is
important that you start to breathe
in as slowly as
possible just
before releas-
ing the dose.
Practice in
front of the
mirror for the
first few times.
If you see
"mist" coming
from the top
of the inhaler or the sides of your
mouth, start again from step 1.
This escaping mist indicates
incorrect technique.
FOR CHILDREN
WARNING
It is essential to keep the plastic
mouthpiece clean, to ensure
proper functioning of the inhaler.
Clean your inhaler at least once
a week, as follows:
Gently pull the metal canister
out of the plastic body of the
inhaler. Remove the
mouthpiece cover.
Immerse the
and
the mouthpiece cover in warm
water.
Next, rinse the plastic
mouthpiece cover
under running tap water.
Shake well to remove excess
water.
plastic body
body and
DO NOT PUT THE METAL
CANISTER IN THE WATER.
1.
2.
3.
4.
Leave to dry in warm place.
Avoid excess heat.
Replace the canister and the
mouthpiece cover correctly.
5.
If the rec

Summary of Product characteristics

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
DUOLIN INHALER (CFC FREE)
COMPOSITION
Each actuation delivers
Salbutamol Sulphate BP
Equivalent to Salbutamol ……100 mcg
Ipratropium Bromide monohydrate BP equivalent
to Ipratropium Bromide anhydrous ……….20 mcg
Suspended in
Propellant HFA-227…………….q.s
DESCRIPTION
A one piece filled metal container fitted with a valve with plastic
stem and printed
with product name, batch number and container number. On visual
examination
there should be no sign of physical damage such as dents, bulged
containers
bent valve stem and uneven crimping. A white coloured powder is
obtained after
opening the container.
PHARMACODYNAMICS
Ipratropium bromide is an anticholinergic agent which inhibits vagally
mediated
reflexes by antagonising the action of acetylcholine, the transmitter
agent
released
from
the
vagus
nerve.
The
bronchodilation
following
inhalation
of
ipratropium bromide is primarily local and site specific to the lung
and not
systemic in nature.
Salbutamol sulphate is a beta
2
-adrenergic agent which acts on airway smooth
muscle resulting in relaxation. Salbutamol relaxes all smooth muscle
from the
trachea to the terminal bronchioles and protects against all
bronchoconstrictor
challenges.
The combination of ipratropium with sabutamol provides the
simultaneous
release of ipratropium bromide and salbutamol sulphate allowing the
synergistic
efficacy on the muscarinic and beta
2
-adrenergic receptors in the lung to cause
bronchodilation.
PHARMACOKINETICS
Ipratropium bromide is not readily absorbed into the systemic
circulation either
from the surface of the lung or from the gastrointestinal tract as
compared by
blood level and renal excretion studies. The half-life elimination of
drug and
metabolites is about 3 - 4 hours after inhalation or intravenous
administration.
Ipratropium bromide does not penetrate the blood brain barrier.
Salbutamol
sulphate
is
rapidly
and
completely
absorbed
following
oral
administration either by the