SALBUTAMOL AN salbutamol (as sulfate) 5mg/2.5mL inhalation ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salbutamol sulfate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

salbutamol sulfate

Patient Information leaflet

Salbutamol AN CMI v4.0
Page 1 of 4
CONSUMER MEDICINE INFORMATION
SALBUTAMOL AN
Pronounced (sal-bew-tam-ol)
_Contains the active ingredient salbutamol sulfate _
WHAT IS IN THIS
LEAFLET?
This leaflet answers
some common questions
about Salbutamol AN.
It does not contain all 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 taking
Salbutamol AN against
the benefits this medicine
is expected to have for
you.
IF YOU HAVE ANY
CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This medicine is only part
of a general plan to help
you to manage your
asthma or other chest
conditions. You should
discuss this plan with
your doctor. Ask your
doctor to check your
treatment plan regularly.
Keep this leaflet. You
may need to read it
again.
WHAT SALBUTAMOL AN
IS USED FOR
The name of your
medicine is Salbutamol
AN. The medicine in your
Salbutamol AN ampoules
is delivered through a
device called a nebuliser.
Salbutamol belongs to a
group of medicines called
beta-2-agonists. These
work rapidly to open up
the air passages in your
lungs.
Salbutamol is inhaled into
the lungs for the
treatment of asthma.
Asthma is a disease
where the lining of the
lungs become inflamed
(red and swollen), making
it difficult to breathe. This
may be due to an allergy
to house dust mites,
smoke, air-borne
pollution and other
irritants.
Salbutamol opens up the
air passages in people
suffering from asthma,
bronchitis and other
breathing problems. It
may also be used before
exercise to keep your air
passages open if you
start to wheeze or have
difficulty breathing each
time you exert yourself.
Salbutamol may be used
for the management of
other conditions that are
not mentioned above.
Your doctor will be able
to tell you about the
specific condition for
which you have been
prescribed salbutamol.
This medicine is available
only with a doctor's
prescription.
BEFORE YOU USE
SALBUTAMOL AN
_WHEN YOU MUST NOT BE _
_GIVEN IT_
D

Summary of Product characteristics

Salbutamol AN PI V1.0
1/7
PRODUCT INFORMATION
SALBUTAMOL AN
NAME OF THE MEDICINE
Active: Salbutamol Sulfate BP.
Chemical name:
di[(RS)-2-(1,1-dimethylethyl)amino-1-(4-hydroxy-3-
hydroxymethylphenyl)ethanol]sulfate
Molecular formula: (C
13
H
21
NO
3
)
2
, H
2
SO
4
CAS number: 51022-70-9
MW: 576.7
DESCRIPTION
Salbutamol sulfate is a white or almost white, crystalline, odourless
powder with a slightly
bitter taste. It is freely soluble in water, slightly soluble in
alcohol, chloroform and ether, very
slightly soluble in methylene chloride. Salbutamol sulfate 1.2 mg is
approximately equivalent
to salbutamol 1 mg.
Inactive ingredients: Sodium chloride, sulfuric acid (for pH
adjustment), water for injection.
PHARMACOLOGY
_Action: _Selective _β_
_2 _
adrenoceptor agonist
Salbutamol is a long acting, relatively selective _ β_
_2_
_-_receptor stimulant. Administration by
inhalation results in direct stimulation of _β_
_2_
_-_receptors in bronchial smooth muscle and hence
bronchodilation. This is thought to be due to stimulation of adenyl
cyclase by salbutamol,
resulting in increased levels of cyclic AMP within cells. These are
thought to inhibit the entry
of calcium ions into the cells, thus inhibiting smooth muscle
contraction. High levels of cyclic
AMP in mast cells may also inhibit the release of histamine and slow
reacting substance-A
(SRS-A). After administration of salbutamol stimulation of both _ β_
_1 _
and_ β_
_2 _
receptors occurs
because _ β_
_2 _
selectivity is not absolute. 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.
Stimulation
of
_β_
_2 _
receptors can result in changes in serum levels of glucose, insulin
and potassium.
_Pharmacokinetics: _
_Absorption: _Following inhalation of salbutamol the onset of action
is 5 to 15 minutes. Only 10
to 20% of the dose reaches the lungs, the remainder stays in the
mouth, stomach or on the