AURO-MONTELUKAST CHEWABLE TABLET TABLET (CHEWABLE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MONTELUKAST (MONTELUKAST SODIUM)

Available from:

AURO PHARMA INC

ATC code:

R03DC03

INN (International Name):

MONTELUKAST

Dosage:

4MG

Pharmaceutical form:

TABLET (CHEWABLE)

Composition:

MONTELUKAST (MONTELUKAST SODIUM) 4MG

Administration route:

ORAL

Units in package:

10/30

Prescription type:

Prescription

Therapeutic area:

LEUKOTRIENE MODIFIERS

Product summary:

Active ingredient group (AIG) number: 0133823003; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-03-25

Summary of Product characteristics

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PRODUCT MONOGRAPH
PR
AURO-MONTELUKAST CHEWABLE TABLET
montelukast (as montelukast sodium)
4 mg and 5 mg chewable tablets
Leukotriene Receptor Antagonist
AURO PHARMA INC. Date of Revision:
3700 Steeles Avenue West, Suite # 402 November 10, 2020
Woodbridge, Ontario, L4L 8K8
CANADA
SUBMISSION CONTROL NO.: 244280
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_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
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND
ADMINISTRATION.............................................................................
11
OVERDOSAGE................................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY............................................................
13
STORAGE AND
STABILITY.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 17
PART II: SCIENTIFIC
INFORMATION..........................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
.........................................................................................................
18
TOXICOLOGY.....................