ASMOL 5 UNI-DOSE 5mg salbutamol 5mg/2.5mL inhalation solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salbutamol sulfate

Available from:

Alphapharm Pty Ltd

Authorization status:

Registered

Patient Information leaflet

ASMOL UNI-DOSE
_contains the active ingredient salbutamol (sulphate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Asmol uni-dose.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Asmol uni-dose
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT ASMOL UNI-DOSE
IS USED FOR
Asmol uni-dose are plastic ampoules
which contain a medicine called
salbutamol, as a liquid. The liquid is
changed into a fine mist of droplets
by the nebuliser.
Asmol uni-dose is used for the
treatment of asthma, bronchitis and
other breathing problems.
In people who have difficulty
breathing during exercise, Asmol
uni-dose may also be used before
exercise to keep the air passages
open.
Your doctor may have prescribed
Asmol uni-dose for another purpose.
Ask your doctor if you have any
questions about why Asmol uni-dose
has been prescribed for you.
It belongs to a group of medicines
called bronchodilators or beta-2
agonists. When your chest is tight or
when you are wheezing, Asmol uni-
dose is inhaled into the lungs and
works rapidly to open up the air
passages in your lungs to help you
breathe more easily.
The medicine in Asmol uni-dose
gives fast relief from your chest
symptoms and is often called a
'reliever' medicine.
There is no evidence that Asmol uni-
dose is addictive.
BEFORE YOU USE ASMOL
UNI-DOSE
_WHEN YOU MUST NOT USE IT_
DO NOT USE ASMOL UNI-DOSE IF YOU
HAVE AN ALLERGY TO ANY MEDICINE
CONTAINING SALBUTAMOL.
DO NOT TAKE ASMOL UNI-DOSE TO STOP
A MISCARRIAGE OR PREMATURE
LABOUR.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
�

Summary of Product characteristics

ASMOL UNI-DOSE
_Salbutamol (sulfate)_
PRODUCT INFORMATION
NAME OF MEDICINE
The active ingredient of Asmol uni-dose is salbutamol (as sulfate).
The chemical name for salbutamol sulfate is:
1-(4-hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino)ethanol
sulfate.
Its structural formula is:
Molecular formula:
Molecular Weight:
CAS Registry No.:
(C
13
H
21
NO
3
)
2
H
2
SO
4
288.4
51022-70-9
DESCRIPTION
Salbutamol sulfate is a white or almost white odourless powder. It is
soluble in 4 parts of water, slightly soluble
in 95% alcohol, in chloroform and solvent ether.
PHARMACOLOGY
Salbutamol is a relatively selective β
2
-adrenoreceptor stimulant. It is more specific than both isoprenaline
and
orciprenaline for adrenergic β
2
-receptors.
After oral and parenteral administration, stimulation of the β
-receptors in the body, both β
1
and β
2
, occurs
because:
(a)
β
2
selectivity is not absolute, and
(b)
higher
concentrations
of
salbutamol
occur
in
the
regions
of
these
receptors
with
these
modes
of
administration.
This results in the β
1
effect of cardiac stimulation, though not so much as with
isoprenaline, and β
2
effects of
peripheral vasodilation and hypotension, skeletal muscle tremor and
uterine muscle relaxation.
Metabolic effects such as hyperinsulinaemia and hyperglycaemia also
may occur, although it is not known
whether these effects are mediated by β
1
- or β
2
-receptors. The serum potassium levels have a tendency to fall.
PHARMACOKINETICS
Following
inhalation,
salbutamol
acts
topically
on
bronchial
smooth
muscle
and
initially
the
drug
is
undetectable in the blood. After 2 to 3 hours, low concentrations are
seen, due presumably to the portion of the
dose which is swallowed and absorbed in the gut.
The elimination half-life of inhaled or oral salbutamol is between 2.7
and 5 hours.
CHOH.CH
2
.NHC(CH
3
)
3
HOH
2
C
HO
H
2
SO
4
2
ASMOL uni-dose – Product Information
2
Salbutamol is not metabolised in the lung but is converted to the
4'-o-sulphate ester in the liver. Salbutamol is
excreted in the urine as free