PEDIAZOLE POWDER FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ERYTHROMYCIN (ERYTHROMYCIN ETHYLSUCCINATE); SULFISOXAZOLE (SULFISOXAZOLE ACETYL)

Available from:

AMDIPHARM LIMITED

ATC code:

J01RA02

INN (International Name):

SULFONAMIDES, COMBINATIONS WITH OTHER ANTIBACTERIALS (EXCL.TRIMETHOPRIM)

Dosage:

200MG; 600MG

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

ERYTHROMYCIN (ERYTHROMYCIN ETHYLSUCCINATE) 200MG; SULFISOXAZOLE (SULFISOXAZOLE ACETYL) 600MG

Administration route:

ORAL

Units in package:

105/150/200ML

Prescription type:

Prescription

Therapeutic area:

ERYTHROMYCINS

Product summary:

Active ingredient group (AIG) number: 0252046001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-07-17

Summary of Product characteristics

_ _
_PEDIAZOLE_
_®_
_ Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
PR
PEDIAZOLE
®
erythromycin ethylsuccinate and sulfisoxazole acetyl
for oral suspension USP
200 mg erythromycin 600 mg sulfisoxazole per 5 mL
Antibiotic
Amdipharm Limited,
DATE OF PREPARATION:
Temple Chamber, 3 Burlington Road,
June 3, 2009
Dublin, Dublin 4, Ireland
Distributed by: Methapharm Inc.
DATE OF REVISION:
Brantford, Ontario, N3S 7X6
Submission Control Number: 130056
_ _
_PEDIAZOLE_
_®_
_ Product Monograph _
_Page 2 of 32_
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....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND
ADMINISTRATION..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND
STABILITY..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION.........................................................................