SALBUTAMOL SANDOZ 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:

Sandoz Pty Ltd

INN (International Name):

salbutamol sulfate

Authorization status:

Registered

Patient Information leaflet

SALBUTAMOL SANDOZ
®
_salbutamol sulphate inhalation ampoules_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Salbutamol Sandoz.
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 risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT SALBUTAMOL
SANDOZ IS USED FOR
The name of your medicine is
Salbutamol Sandoz. The medicine in
your Salbutamol Sandoz is delivered
through a device called a nebuliser. It
contains the active ingredient
salbutamol sulphate.
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 Sandoz belongs to a
group of medicines called beta-2-
agonists. These work rapidly to open
up the air passages in your lungs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
SALBUTAMOL SANDOZ
_WHEN YOU MUST NOT USE IT_
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
salbutamol, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product Description
•
any other medicines used to treat
breathing problems or any other
beta

Summary of Product characteristics

_Product Information _
_ _
_Page 1 _
_Salbutamol Sandoz_
_®_
_ 2.5mg/2.5mL, 5mg/2.5mL inhalation ampoules _
08/2016
_Sandoz Pty Ltd _
PRODUCT INFORMATION
SALBUTAMOL SANDOZ
® 2.5MG/2.5ML, 5MG/2.5ML INHALATION
AMPOULES
NAME OF THE MEDICINE
_Generic name:_ Salbutamol sulphate BP
_Chemical name:_ di[(RS)-2-(1,1-dimethyl)ethylamino-1-[4-hydroxy-3-
(hydroxymethyl)phenyl]ethanol] sulphate
_CAS Number:_ 51022-70-9
_Empirical formula:_ (C
13
H
21
NO
3
)
2
, H
2
SO4
_MW:_ 576.7
DESCRIPTION
Salbutamol sulphate 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
sulphate 1.2 mg is
approximately equivalent to salbutamol 1 mg.
Each inhalation ampoule contains Salbutamol 2.5mg/2.5mL or 5mg/2.5mL.
Inactive ingredients: Sodium chloride, sulphuric acid (for pH
adjustment), water for
injection.
PHARMACOLOGY
Selective beta-2-adrenoceptor agonist
Pharmacodynamics
Salbutamol is a long acting, relatively selective beta-2-receptor
stimulant. Administration
by inhalation results in direct stimulation of beta-2-receptors in
bronchial smooth muscle
and hence bronchodilation. This is thought to be due to stimulation of
adenyl cyclase by
CH
2
OH
OH
.H
2
SO
4
OH
NH
CH
C
CH
2
CH
3
CH
3
CH
3
_Product Information _
_ _
_Page 2 _
_Salbutamol Sandoz_
_®_
_ 2.5mg/2.5mL, 5mg/2.5mL inhalation ampoules _
08/2016
_Sandoz Pty Ltd _
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 beta-1 and
beta-2 receptors occurs
because beta-2 selectivity is not absolute. This results in the beta-1
effect of cardiac
stimulation, though not so much as with isoprenaline, and beta-2
effects