ACCOLATE TAB 20 MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZAFIRLUKAST

Available from:

ASTRAZENECA CANADA INC

ATC code:

R03DC01

INN (International Name):

ZAFIRLUKAST

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

ZAFIRLUKAST 20MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

LEUKOTRIENE MODIFIERS

Product summary:

Active ingredient group (AIG) number: 0132111001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-01-02

Summary of Product characteristics

- 1 -
COPYRIGHT 1997, 2000, 2012 ASTRAZENECA CANADA INC.
PRODUCT MONOGRAPH
ACCOLATE
®
(zafirlukast tablets)
Leukotriene Receptor Antagonist
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.com
Date of Revision:
November 18, 2013
SUBMISSION CONTROL NO. 167197
ACCOLATE
®
is a registered trademark of the AstraZeneca group of companies.
- 2 -
COPYRIGHT 1997, 2000, 2012 ASTRAZENECA CANADA INC.
PRODUCT MONOGRAPH
NAME OF DRUG
ACCOLATE
®
(zafirlukast tablets)
Tablets 20 mg
THERAPEUTIC CLASSIFICATION
Leukotriene Receptor Antagonist
ACTIONS AND CLINICAL PHARMACOLOGY
Zafirlukast is a selective and competitive receptor antagonist of
leukotriene D
4
and E
4
(LTD
4
and LTE
4
). Cysteinyl leukotriene production and receptor occupation have been
correlated
with the pathophysiology of asthma, including airway edema, smooth
muscle constriction, and
altered cellular activity associated with the inflammatory process,
which contribute to the
signs and symptoms of asthma. Patients with asthma were found in one
study to be 25-100
times more sensitive to the bronchoconstricting activity of inhaled
LTD
4
than nonasthmatic
subjects.
_In vitro_ studies demonstrated that zafirlukast antagonized the
contractile activity of three
leukotrienes (LTC
4
, LTD
4
and LTE
4
) in conducting airway smooth muscle from laboratory
animals and humans. Zafirlukast prevented intradermal LTD
4
-induced increases in cutaneous
vascular permeability and inhibited inhaled LTD
4
-induced influx of eosinophils into animal
lungs. Inhalational challenge studies in sensitized sheep showed that
zafirlukast suppressed
the airway responses to antigen; this included both the early- and
late-phase response and the
nonspecific hyperresponsiveness.
In humans, zafirlukast inhibited bronchoconstriction caused by several
kinds of inhalational
challenges. Pretreatment with single oral doses of zafirlukast
inhibited the
bronchoconstriction caused by sulfur dioxide and cold air in patients
with asthma.
Pretreatment with single doses of