CIPROFLOXACIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Available from:

COBALT PHARMACEUTICALS COMPANY

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

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:

CANCELLED PRE MARKET

Authorization date:

2017-09-01

Summary of Product characteristics

_ _
Ciprofloxacin_ _
_Page 1 of 46_
PRODUCT MONOGRAPH
_PR_ CIPROFLOXACIN
(Ciprofloxacin Tablets, USP)
Tablets 250 mg, 500 mg, & 750 mg
Ciprofloxacin (as Ciprofloxacin Hydrochloride)
Antibacterial Agent
Manufactured by:
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Revision:
May 11, 2012
Submission Control No: 155219
_ _
Ciprofloxacin_ _
_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
6
WARNINGS AND
PRECAUTIONS.................................................................................
6
ADVERSE
REACTIONS.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND
ADMINISTRATION.............................................................................
16
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND
STABILITY.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.........................................................................
23
CLINICAL
TRIALS......................................................................................................