MONTELUKAST TABLET (CHEWABLE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-04-2021
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Active ingredient:
MONTELUKAST (MONTELUKAST SODIUM)
Available from:
PRO DOC LIMITEE
ATC code:
R03DC03
INN (International Name):
MONTELUKAST
Dosage:
5MG
Pharmaceutical form:
TABLET (CHEWABLE)
Composition:
MONTELUKAST (MONTELUKAST SODIUM) 5MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
LEUKOTRIENE MODIFIERS
Product summary:
Active ingredient group (AIG) number: 0133823001; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-03-28
Summary of Product characteristics
_MONTELUKAST Product Monograph _
_Page 1 of 34_
PRODUCT MONOGRAPH
PR
MONTELUKAST
Montelukast Sodium Tablets USP
10 mg
Montelukast Sodium Chewable Tablets USP
4 mg and 5 mg
LEUKOTRIENE RECEPTOR ANTAGONIST
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
DATE OF REVISION:
April 01, 2021
SUBMISSION CONTROL NO: 249708
_MONTELUKAST Product Monograph _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 14
STORAGE AND STABILITY
.................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
.................................................................................
19
CLINICAL TRIALS
...............
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