ZADITEN SYRUP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOTIFEN (KETOTIFEN FUMARATE)

Available from:

TEVA CANADA LIMITED

ATC code:

R06AX17

INN (International Name):

KETOTIFEN

Dosage:

1MG

Pharmaceutical form:

SYRUP

Composition:

KETOTIFEN (KETOTIFEN FUMARATE) 1MG

Administration route:

ORAL

Units in package:

250ML

Prescription type:

Prescription

Therapeutic area:

OTHER ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0115676002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-07-30

Summary of Product characteristics

PRODUCT MONOGRAPH
ZADITEN
®
(ketotifen fumarate)
Tablets 1 mg
Syrup 1 mg/5 mL
Pediatric Asthma Prophylactic
and Antiallergic Agent
Teva Canada Limited
DATE OF PREPARATION:
30 Novopharm Court
October 29, 2010
Toronto, ON
M1B 2K9
Control #: 142434
- 2 -
TABLE OF CONTENTS
Page
ACTIONS AND CLINICAL PHARMACOLOGY
- 3 -
INDICATIONS AND CLINICAL USE
- 5 -
CONTRAINDICATIONS
- 6 -
PRECAUTIONS
- 6 -
ADVERSE REACTIONS
- 7 -
SYMPTOMS AND TREATMENT OF OVERDOSAGE
- 9 -
DOSAGE AND ADMINISTRATION
- 10 -
PHARMACEUTICAL INFORMATION
- 11 -
AVAILABILITY OF DOSAGE FORMS
- 13 -
INFORMATION FOR THE PATIENTS/PARENTS
- 14 -
PHARMACOLOGY
- 16 -
TOXICOLOGY
- 20 -
BIBLIOGRAPHY
- 24 -
- 3 -
PRODUCT MONOGRAPH
NAME OF DRUG
ZADITEN®
(ketotifen fumarate)
Tablets 1 mg
Syrup 1 mg/5 mL
THERAPEUTIC CLASSIFICATION
Pediatric Asthma Prophylactic and Anti-Allergic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Ketotifen (ketotifen fumarate) is a non-bronchodilator anti-asthmatic
drug which inhibits
the effects of certain endogenous substances known to be inflammatory
mediators, and
thereby exerts anti-allergic activity. Preclinical studies indicated
that Zaditen's anti-H
1
effect seems to be distinct from its anti-allergic properties.
The effectiveness of Zaditen in the chronic management of mild atopic
pediatric asthma
has been shown in clinical trials. Continued use of Zaditen results in
a partial reduction
in the frequency, severity and duration of asthma symptoms and
attacks, and may lead to
the reduction in the daily requirements of concomitant anti-asthmatic
medication such as
theophyllines and
β
2
-agonists, without the deterioration in pulmonary function (FEV
1
,
FVC and PEFR). Clinical improvements have been observed in some cases
within the
first weeks of treatment and generally reach statistical significance
after ten weeks.
Zaditen may have an anti-inflammatory effect in the lungs and the time
of onset of
clinical efficacy may reflect the recovery period of the lungs from
inflammation.
Pharmacological studies have revealed a number of properties