VENTOLIN SYRUP salbutamol 2mg/5mL (as sulfate) sugar free oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salbutamol sulfate, Quantity: 0.48 mg/mL (Equivalent: salbutamol, Qty 0.4 mg/mL)

Available from:

GlaxoSmithKline Australia Pty Ltd

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: sodium benzoate; hypromellose; citric acid monohydrate; sodium chloride; purified water; sodium citrate dihydrate; saccharin sodium; Flavour

Administration route:

Oral

Units in package:

150mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 14 FEBRUARY 2005: Ventolin is indicated for the prevention and relief of bronchospasm in bronchial asthma of all types and for the alleviation of any reversible airways obstruction associated with conditions such as chronic bronchitis or emphysema.

Product summary:

Visual Identification: SLIGHTLY HAZY VISCOUS LIQUID; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-01-28

Patient Information leaflet

VENTOLIN
® SUGAR FREE
SYRUP
_Salbutamol sulphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take Ventolin Sugar Free
Syrup.
This leaflet answers some common
questions about Ventolin Sugar Free
Syrup. 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 risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking Ventolin Sugar
Free Syrup against the risks this
medicine could have for you.
IF THERE IS ANYTHING YOU DO NOT
UNDERSTAND OR IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST. IF YOU WANT MORE
INFORMATION, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS VENTOLIN
SUGAR FREE SYRUP
USED FOR?
Ventolin Sugar Free Syrup helps you
breathe more easily. Ventolin Sugar
Free Syrup works by opening up the
airways tubes in your lungs when
your chest is tight or when you are
wheezing.
Ventolin Sugar Free Syrup belongs
to a group of medicines called
bronchodilators. Because the
medicine in your syrup gives relief
from your chest symptoms, it is often
called a 'reliever'.
There are other types of medicines
that prevent wheezing or chest
tightness. These medicines are called
'preventers' and must be used every
day. Your doctor may tell you to use
a 'preventer' in addition to your
Ventolin Sugar Free Syrup. Ventolin
Sugar Free Syrup is not the only
form of Ventolin available. Your
doctor will decide which form of
Ventolin is right for you.
Your doctor may have prescribed
Ventolin Sugar Free Syrup for
another reason.
Ventolin Sugar Free Syrup is not
addictive.
BEFORE YOU TAKE
VENTOLIN SUGAR FREE
SYRUP
_DO NOT TAKE IF:_
You must not take Ventolin Sugar
Free Syrup:
•
if you have ever had an allergic
reaction to salbutamol sulphate or
any of the ingredients listed
toward the end of this leafl

Summary of Product characteristics

1
PRODUCT INFORMATION
VENTOLIN
SUGAR FREE SYRUP AND INJECTION
NAME OF THE MEDICINE:
Salbutamol Sulphate BP
CHEMICAL NAME
1-(4-hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino)ethanol Sulphate.
STRUCTURE
MOLECULAR FORMULA:
(C
13
H
21
NO
3
)
2
H
2
SO
4
DESCRIPTION:
Salbutamol sulphate is a white or almost white odourless powder. It is
soluble in 4 parts of
water; slightly soluble in 95% alcohol, chloroform and solvent ether.
Ventolin Sugar Free Syrup contains the following excipients: sodium
citrate, citric acid
monohydrate, hypromellose, sodium benzoate, saccharin sodium, sodium
chloride, water –
purified and orange flavouring.
Ventolin Injection contains the following excipients: sodium chloride,
sulfuric acid and water
for injections.
PHARMACOLOGY:
Salbutamol is a relatively selective beta-2 adrenoreceptor stimulant.
It is more specific than
both isoprenaline and orciprenaline for adrenergic beta-2 receptors.
After oral and parenteral administration, stimulation of the beta
receptors in the body, both
beta-1 and beta-2, occurs because (a) beta-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 beta-1 effect of cardiac
stimulation, though not so much as
with isoprenaline, and beta-2 effects of peripheral vasodilatation 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 beta-1 or beta-2
receptors. The serum
potassium levels have a tendency to fall.
CHOH.CH
2
.NHC(CH
3
)
3
HOH
2
C
HO
H
2
SO
4
2
2
PHARMACOKINETICS
Peak plasma levels occur at 2 to 4 hours after oral administration of
salbutamol.
The elimination half-life of oral or inhaled salbutamol is between 2.7
and 5 hours.
Salbutamol is not metabolized in the lung but is converted to the
4'-o-sulphate ester in the
liver. Salbutamol is excreted in the urine as free drug and as the
metab