Salapin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Salbutamol sulfate 0.482 mg/mL (eqv to 0.4mg/mL of salbutamol)

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Salbutamol sulfate 0.482 mg/mL (eqv to 0.4mg/mL of salbutamol)

Dosage:

2 mg/5mL

Pharmaceutical form:

Syrup

Composition:

Active: Salbutamol sulfate 0.482 mg/mL (eqv to 0.4mg/mL of salbutamol) Excipient: Citric acid monohydrate Glycerol Purified water Raspberry flavour 517503E Saccharin sodium Sodium benzoate Sodium citrate dihydrate Xanthan gum

Units in package:

Bottle, glass, Amber, Type III glass with pilfer proof aluminium cap, 150 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

Therapeutic indications:

Salapin is indicated for relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. Salapin is suitable oral therapy for children or those adults who prefer liquid medicines.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, Amber, Type III glass with pilfer proof aluminium cap - 150 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PE CRC cap - 150 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2002-08-23

Summary of Product characteristics

SALAPIN
SALBUTAMOL SYRUP 2MG/5ML
QUALITATIVE AND QUANTITATIVE COMPOSITION
Salapin: Salbutamol BP 2mg as sulphate in each 5mL of a raspberry cola
flavoured,
sugar free syrup.
CLINICAL PARTICULARS
_THERAPEUTIC INDICATIONS _
Salbutamol is a selective β
2
adrenoceptor agonist. At therapeutic doses it acts on the
β
2
adrenoceptors
of
bronchial
muscle,
with
little
or
no
action
on
the
β-1
adrenoceptors of the heart. It is suitable for the management and
prevention of attack
in asthma.
Bronchodilators should not be the only or main treatment in patients
with severe or
unstable asthma. Severe asthma requires regular medical assessment as
death may
occur.
Patients
with
severe
asthma
have
constant
symptoms
and
frequent
exacerbations, with limited physical capacity, and PEF values below
60% predicted
at baseline with greater than 30% variability, usually not returning
entirely to normal
after a bronchodilator. These patients will require high dose inhaled
(eg >1mg/day
beclomethasone dipropionate) or oral corticosteroid therapy. Sudden
worsening of
symptoms
may
require
increased
corticosteroid
dosage
which
should
be
administered under urgent medical supervision.
Salapin is indicated for relief of bronchospasm in bronchial asthma of
all types,
chronic bronchitis and emphysema.
Salapin
is
suitable
oral
therapy
for
children
or
those
adults
who
prefer
liquid
medicines.
_POSOLOGY AND METHOD OF ADMINISTRATION _
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of β
2
agonists may be a sign of worsening asthma.
Under these conditions a reassessment of the patient's therapy plan
may be required
and concomitant glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the
dosage or
frequency of administration should only be increased on medical
advice.
ADULTS:
The usual effective dose is 10mL salbutamol (4 milligrams of
salbutamol) three or
four times per day. If adequate bronchodilation is not obtained each
single dose may
be gradually in