MAR-LACOSAMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LACOSAMIDE

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

N03AX18

INN (International Name):

LACOSAMIDE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

LACOSAMIDE 150MG

Administration route:

ORAL

Units in package:

250ML

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0152810003; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-04-26

Summary of Product characteristics

Page 1 of 48
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-LACOSAMIDE
Lacosamide
Film-coated tablets, 50 mg, 100 mg, 150 mg, 200 mg lacosamide, Oral
Mfr. Std
Antiepileptic
ATC Code: N03AX18
Marcan Pharmaceuticals Inc.
2 Gurdwara Road,
Suite #112, Ottawa
ON K2E 1A2
Date of Initial Authorization:
APR 24, 2019
Date of Revision:
JAN 19, 2023
Submission Control Number: 271089
_Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
01/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
...............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4
Administration
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6
4.5
Missed Dose
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