IMITREX DF - TAB 25MG 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:

25MG

Pharmaceutical form:

TABLET

Composition:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 25MG

Administration route:

ORAL

Units in package:

24

Prescription type:

Prescription

Therapeutic area:

SELECTIVE SEROTONIN AGONISTS

Product summary:

Active ingredient group (AIG) number: 0123238007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-01-19

Summary of Product characteristics

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_Page 1 of 58_
PRODUCT MONOGRAPH
PR
IMITREX DF™
(sumatriptan succinate tablets)
25 mg, 50 mg and 100 mg sumatriptan
PR
IMITREX
®
(sumatriptan succinate injection)
6 mg sumatriptan
Subcutaneous Injection and Autoinjector
PR
IMITREX
®
(sumatriptan nasal spray)
5 mg and 20 mg sumatriptan (as hemisulphate)
5-HT
1
Receptor Agonist
Migraine Therapy
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
October 24, 2007
Submission Control No: 115677
©
2007 GlaxoSmithKline, All Rights Reserved
™ IMITREX DF is a trademark, used under license by GlaxoSmithKline
Inc.
®
IMITREX is a registered trademark, used under license by
GlaxoSmithKline Inc.
®
IMITREX STATdose Pen and IMITREX STATdose System are registered
trademarks, used under license by
GlaxoSmithKline Inc.
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_Page 2 of 58_
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..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND
STABILITY......................................................................