PMS-CIPROFLOXACIN XL TABLET (IMMEDIATE AND EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIPROFLOXACIN (CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE)

Available from:

PHARMASCIENCE INC

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN

Dosage:

500MG

Pharmaceutical form:

TABLET (IMMEDIATE AND EXTENDED RELEASE)

Composition:

CIPROFLOXACIN (CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE) 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

QUINOLONES

Product summary:

Active ingredient group (AIG) number: 0123207001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-11-21

Summary of Product characteristics

_pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin
extended-release tablets) _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PMS-CIPROFLOXACIN XL
Ciprofloxacin Hydrochloride and Ciprofloxacin Extended-Release Tablets
Tablets (Immediate and Extended-Release), 500 mg ciprofloxacin (as
ciprofloxacin and
ciprofloxacin hydrochloride) , Oral
House Standard
Antibacterial Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization
NOV 21, 2013
Date of Revision:
Jan 11, 2022
Submission Control No: 255878
_pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin
extended-release tablets) _
_Page 2 of 62_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
..................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................4
1
INDICATIONS
........................................................................................................................4
1.1
Pediatrics
...................................................................................................................5
1.2
Geriatrics
...................................................................................................................5
2
CONTRAINDICATIONS
...........................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................5
4
DOSAGE AND ADMINISTRATION
...........................................................................................6
4.1
Dosing Considerations
................................................................................................6
4.2
Recommended Dose and Dosage Adjustment
......................