PMS-SALBUTAMOL ORAL LIQUID SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

Available from:

PHARMASCIENCE INC

ATC code:

R03CC02

INN (International Name):

SALBUTAMOL

Dosage:

0.4MG

Pharmaceutical form:

SOLUTION

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 0.4MG

Administration route:

ORAL

Units in package:

250 ML

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0108887004; AHFS:

Authorization status:

APPROVED

Authorization date:

2003-05-28

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-SALBUTAMOL ORAL LIQUID
_Salbutamol Sulphate Solution _
_0.4 mg Salbutamol/mL _
Bronchodilator
(beta
2
-adrenergic agonist)
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave, Suite 100
February 5, 2015
Montréal, Québec
H4P 2T4
www.pharmascience.com
Control no. : 179272
_pms-SALBUTAMOL ORAL LIQUID Product Monograph _
_Page 2 of 21_
PRODUCT MONOGRAPH
PR
PMS-SALBUTAMOL ORAL LIQUID
Salbutamol Sulphate Solution
CLINICAL PHARMACOLOGY
Salbutamol produces bronchodilation through stimulation of beta
2
-adrenergic receptors in
bronchial smooth muscle, thereby causing relaxation of bronchial
muscle fibres. This action is
manifested by an improvement in pulmonary function as demonstrated by
spirometric
measurements.
A measurable decrease in airway resistance is typically observed 30
minutes after an oral dose of
salbutamol sulphate. The maximum improvement in pulmonary function
usually occurs after 2 to
3 hours, and significant bronchodilator activity has been observed to
persist for 6 hours or
longer.
INDICATIONS AND CLINICAL USE
Prevention or relief of bronchospasm due to bronchial asthma, chronic
bronchitis and other
chronic bronchopulmonary disorders in which bronchospasm is a
complicating factor.
CONTRAINDICATIONS

Patients who are hypersensitive to salbutamol sulphate or any of the
ingredients of
pms-SALBUTAMOL ORAL LIQUID. For a complete listing of ingredients, see
PHARMACEUTICAL INFORMATION, COMPOSITION.

Patients with tachyarrhythmias.

Children 2 years of age and younger.

As a tocolytic in patients at risk of premature labour or threatened
abortion.
_pms-SALBUTAMOL ORAL LIQUID Product Monograph _
_Page 3 of 21_
WARNINGS
USE OF ANTI-INFLAMMATORY AGENTS: In accordance with the present
practice for
asthma treatment, concomitant anti-inflammatory therapy should be part
of the regimen if
salbutamol needs to be used on a regular daily basis (see DOSAGE AND
ADMINISTRATION).
It is essential that the physician instruct the patient in the need
for further evaluation if the
patien