BUTAMOL 2.5 salbutamol 2.5mg/2.5mL (as sulfate) inhalation ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salbutamol sulfate

Available from:

Aspen Pharma Pty Ltd

INN (International Name):

salbutamol sulfate

Authorization status:

Registered

Patient Information leaflet

BUTAMOL- Consumer Medicine Information
Page 1 of 3
Butamol
_SALBUTAMOL _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Butamol 2.5 and
Butamol 5. It does not contain all
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you taking this medicine
against the benefits it is expected
to have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
This medicine is only part of a
general plan to help you 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 WITH THE
MEDICINE.
You may want to read it again
WHAT BUTAMOL IS USED FOR
The name of your medicine is
Butamol 2.5 or Butamol 5. The
medicine is delivered through a
device called a nebuliser.
Butamol contains a medicine called
Salbutamol, which 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 inhalation 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 Butamol 2.5 or Butamol
5. This medicine is only available
with a doctor’s prescription
BEFORE YOU USE
IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE BUT

Summary of Product characteristics

BUTAMOL- Product Information
Page 1 of 7
BUTAMOL
PRODUCT INFORMATION
NAME OF THE MEDICINE
_ _
_BUTAMOL 2.5, BUTAMOL 5 _
Active:
Salbutamol sulfate.
(C
13
H
21
NO
3
)
2
,H
2
SO
4
Molecular weight: 576.7
Cas No.: 51022-70-9
DESCRIPTION
Chemical name: di[(RS)-2-(1,1-dimethyl)ethylamino-1- [4-hydroxy-3 -
(hydroxymethyl)phenyl]ethanol] sulfate.
Salbutamol sulfate is a white or almost white odourless, crystalline
powder with a slightly bitter
taste. It is freely soluble in water, practically insoluble or very
slightly soluble in ethanol (96 per
cent) and in methylene chloride. Salbutamol sulfate 1.2 mg is
approximately equivalent to
salbutamol 1 mg.
Butamol 2.5 and Butamol 5 ampoules are clear, aqueous isotonic,
preservative-free nebuliser
solutions for single use.
BUTAMOL 2.5: Each single dose ampoule contains salbutamol (as sulfate)
2.5 mg in 2.5 mL.
Excipients: Sodium Chloride, Sulfuric acid and Water for Injections.
BUTAMOL 5: Each single dose ampoule contains salbutamol (as sulfate) 5
mg in 2.5 mL. Excipients:
Sodium Chloride, Sulfuric acid and Water for Injections.
PHARMACOLOGY
_Action:_ beta 2-adrenoreceptor agonist.
Salbutamol is a long acting, relatively selective beta2-receptor
stimulant. Administration by
inhalation results in direct stimulation of beta 2-receptors in
bronchial smooth muscle and, hence,
bronchodilatation. This is thought to be due to stimulation of adenyl
cyclase by salbutamol, resulting
in increased levels of cyclic adenosine monophosphate (AMP) within
cells. These are thought to
inhibit the entry of calcium ions into the cells, thus inhibiting
smooth muscle contraction. High levels
BUTAMOL- Product Information
Page 2 of 7
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 beta1 and
beta2-receptors occurs because
beta2 selectivity is not absolute. This results in the beta1 effect of
cardiac stimulation, though not so
much as with isoprenaline, and beta2 effects of peripheral
vas