CIPRO TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-02-2020
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Active ingredient:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
Available from:
BAYER INC
ATC code:
J01MA02
INN (International Name):
CIPROFLOXACIN
Dosage:
750MG
Pharmaceutical form:
TABLET
Composition:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 750MG
Administration route:
ORAL
Units in package:
50/100
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0123207002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-12-10
Summary of Product characteristics
_CIPRO_
_®_
_ and CIPRO_
®
_ ORAL SUSPENSION_
Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CIPRO
®
(Ciprofloxacin tablet USP)
250 mg, 500 mg, 750 mg
PR
CIPRO
® ORAL SUSPENSION
(Ciprofloxacin oral suspension)
10 g/100 mL
Antibacterial Agent
Manufactured by:
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Revision:
February 18, 2020
Submission Control No: 233351
© 2020, Bayer Inc.
® TM see www.bayer.ca/tm-mc
All other trademarks are the property of their respective owners.
_CIPRO_
_®_
_ and CIPRO_
®
_ ORAL SUSPENSION_
Page 2 of 58
TABLE OF CONTENTS
PART
I:
HEALTH
PROFESSIONAL
INFORMATION ..........................................................
3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
7
WARNINGS AND PRECAUTIONS
.............................................................................................
8
ADVERSE REACTIONS
.............................................................................................................
14
DRUG INTERACTIONS
.............................................................................................................
17
DOSAGE AND ADMINISTRATION
.........................................................................................
22
OVERDOSAGE
...........................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
26
STORAGE AND STABILITY
.....................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................
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