Ventolin Expectorant Syrup 1mg/50mg per 5mL Syrup

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Salbutamol (As Sulfate) , Guaifenesin

Available from:

GlaxoSmithKline Philippines, Inc.

INN (International Name):

Salbutamol (As Sulfate) + Guaifenesin

Dosage:

1mg/50mg per 5mL

Pharmaceutical form:

Syrup

Units in package:

Boston amber bottle (60mL and 120mL)

Manufactured by:

SmithKline Beecham, Philippines

Authorization date:

2018-01-03

Patient Information leaflet

Page 1 of 9 SALBUTAMOL-GUAIPHENSIN
TITLE
Salbutamol sulphate-guaiphenesin
SCOPE
TRADE NAME(S)
_VENTOLIN _Expectorant Syrup
FORMULATION, STRENGTH AND DEVICE* (*IF APPROPRIATE)
Syrup.
2 mg salbutamol, as sulphate, and 100 mg guaiphenesin in each 10 ml of
syrup.
EXCIPIENTS
Hydroxypropyl methylcellulose
Sodium benzoate
Saccharin sodium
Lactic acid
Sodium hydroxide
Orange flavour (IFF 17.40.0095)
Purified water
(or as registered locally).
Sugar-containing formulation: _statement needed − see Warnings and
Precautions_
CLINICAL INFORMATION
INDICATIONS
Salbutamol is a selective beta-
2
adrenoceptor agonist indicated for the treatment or prevention
of bronchospasm. It provides short acting (four hours) bronchodilation
in reversible airways
obstruction due to asthma, chronic bronchitis and emphysema.
Bronchodilators should not be the only or main treatment in patients
with persistent asthma. In
patients with persistent asthma unresponsive to salbutamol, treatment
with inhaled
corticosteroids is recommended to achieve and maintain control.
Failing to respond to
treatment with salbutamol may signal a need for urgent medical advice
or treatment. The
Page 2 of 9
combination of salbutamol with guaiphenesin is designed to relieve
respiratory obstruction and
improve pulmonary ventilation.
Respiratory disorders where bronchospasm and excessive secretion of
tenacious mucus are
complicating factors, e.g. bronchial asthma, chronic bronchitis and
emphysema.
DOSAGE AND ADMINISTRATION
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta-
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.
POPULATIONS
The volumes of syrup quoted are based on a formulation strength of 2
mg salbutamol per
10 ml of syrup.
•