CIPRO I.V. MINIBAGS 2MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIPROFLOXACIN

Available from:

BAYER INC

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

CIPROFLOXACIN 2MG

Administration route:

INTRAVENOUS

Units in package:

10

Prescription type:

Prescription

Therapeutic area:

QUINOLONES

Product summary:

Active ingredient group (AIG) number: 0123207007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-08-05

Summary of Product characteristics

© 2008, Bayer Inc.
® CIPRO is a registered trademard, used under license by Bayer Inc.
PRODUCT MONOGRAPH
CIPRO
®
(CIPROFLOXACIN HYDROCHLORIDE TABLETS)
250 MG, 500 MG, 750 MG
U.S.P.
CIPRO
® I.V.
(CIPROFLOXACIN INJECTION)
10 MG/ML IN WATER FOR INJECTION
BAYER STANDARD
CIPRO
® I.V. MINIBAGS
(CIPROFLOXACIN INJECTION)
2 MG/ML IN 5% DEXTROSE
BAYER STANDARD
CIPRO
® ORAL SUSPENSION
(CIPROFLOXACIN ORAL SUSPENSION)
10G/100 ML
BAYER STANDARD
ANTIBACTERIAL AGENT
BAYER INC.
DATE OF REVISION:
77 BELFIELD ROAD
JUNE 5, 2008
TORONTO, ONTARIO
M9W 1G6
CANADA
WWW.BAYER.CA
CONTROL NUMBER:
120682
2
PRODUCT MONOGRAPH
CIPRO
®
(Ciprofloxacin Hydrochloride Tablets)
250 mg, 500 mg, 750 mg
U.S.P.
CIPRO
®
I.V.
(Ciprofloxacin Injection)
10 mg/mL in Water for Injection
Bayer Standard
CIPRO
®
I.V. MINIBAGS
(Ciprofloxacin Injection)
2 mg/mL in 5% Dextrose
Bayer Standard
CIPRO
®
ORAL SUSPENSION
(Ciprofloxacin Oral Suspension)
10 g/100 mL
Bayer Standard
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
3
ACTION AND CLINICAL PHARMACOLOGY
ACTION
Ciprofloxacin, a synthetic fluoroquinolone, has
_in vitro _
activity against a wide range of gram-
negative and gram-positive microorganisms. Its bactericidal action is
achieved through inhibition
of topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II
topoisomerases), which are
required for bacterial DNA replication, transcription, repair, and
recombination.
Ciprofloxacin retained some of its bactericidal activity after
inhibition of RNA and protein synthesis
by rifampin and chloramphenicol, respectively. These observations
suggest ciprofloxacin may
possess two bactericidal mechanisms, one mechanism resulting from the
inhibition of DNA gyrase
and a second mechanism which may be independent of RNA and protein
synthesis.
The mechanism of action of fluoroquinolones, including ciprofloxacin,
is different from that of
penicillins,
cephalosporins,
aminoglycosides,
macrolides,
and
tetracyclines.
Therefore,
microorganisms resistant to these classes of drugs may be susceptible
to ciprofloxacin. Co