TEVA-MEXILETINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEXILETINE HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

C01BB02

INN (International Name):

MEXILETINE

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

MEXILETINE HYDROCHLORIDE 100MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Prescription

Therapeutic area:

CLASS IB ANTIARRYTHMICS

Product summary:

Active ingredient group (AIG) number: 0116151001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-05-15

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-MEXILETINE
Mexiletine Hydrochloride
Capsules, 100 mg and 200mg, Oral
USP
Antiarrhythmic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Date of Initial Authorization:
December 24, 1996
Date of Revision:
November 27, 2023
Submission Control Number: 272846
TEVA-MEXILETINE (Mexiletine HCl)
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
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5
5
OVERDOSAGE
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