IMITREX DF - TAB 50MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE)

Available from:

GLAXOSMITHKLINE INC

ATC code:

N02CC01

INN (International Name):

SUMATRIPTAN

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 50MG

Administration route:

ORAL

Units in package:

24

Prescription type:

Prescription

Therapeutic area:

SELECTIVE SEROTONIN AGONISTS

Product summary:

Active ingredient group (AIG) number: 0123238002; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-07-05

Summary of Product characteristics

_ _
_ _
_IMITREX sumatriptan _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IMITREX DF
(sumatriptan succinate tablets USP)
50 mg and 100 mg sumatriptan
PR
IMITREX
(sumatriptan injection, Mfr. Std)
6 mg / 0.5 mL sumatriptan (as sumatriptan succinate)
Subcutaneous Injection and Autoinjector
PR
IMITREX
(sumatriptan nasal spray, Mfr. Std)
5 mg and 20 mg sumatriptan (as hemisulphate)
5-HT
1
Receptor Agonist
Migraine Therapy
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
January 20, 1992
Date of Revision:
October 24, 2022
Submission Control Number: 264269
_©_
_ 2022 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
_ _
_IMITREX sumatriptan _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
09/2021
7 Warnings and Precautions, Serotonin toxicity / Serotonin
Syndrome
09/2021
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
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION..................................