FLOXIN TABLETS 300MG

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OFLOXACIN

Available from:

JANSSEN INC

ATC code:

J01MA01

INN (International Name):

OFLOXACIN

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

OFLOXACIN 300MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Prescription

Therapeutic area:

QUINOLONES

Product summary:

Active ingredient group (AIG) number: 0122759001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2006-12-21

Summary of Product characteristics

D:\FLO040704A.04nonann.wpd
PRODUCT MONOGRAPH
Pr
FLOXIN*
ofloxacin
Tablets
Antibacterial Agent
This product monograph is the exclusive property of
Janssen-Ortho Inc. It may not be copied in whole or in part
without the expressed permission of Janssen-Ortho Inc.
Janssen-Ortho Inc.
DATE OF PREPARATION:
Toronto, Ontario
April 6, 1999
M3C 1L9
Control #: 105678
DATE OF REVISION:
July 4, 2006
© 2006 JANSSEN-ORTHO Inc.
*All trademark rights used under license
1
D:\FLO040704A.04nonann.wpd
PRODUCT MONOGRAPH
Pr
FLOXIN*
ofloxacin
Tablets
Antibacterial Agent
CLINICAL PHARMACOLOGY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of FLOXIN (ofloxacin) Tablets and
other antibacterial drugs, FLOXIN (ofloxacin) Tablets should be used
only to treat or prevent infections that are proven
or strongly suspected to be caused by bacteria.
Action:
FLOXIN (ofloxacin) Tablets are a broad-spectrum, synthetic
fluoroquinolone antibacterial agent for oral administration.
Ofloxacin is thought to exert a bactericidal effect on susceptible
bacterial cells by inhibiting the essential bacterial
enzyme, DNA gyrase, a critical catalyst in the replication,
transcription and repair of bacterial DNA.
Pharmacology:
The pharmacokinetic profile of FLOXIN (ofloxacin) Tablets is
comparable to the profile of ofloxacin administered
intravenously. The bioavailability of ofloxacin in the tablet
formulation is approximately 98%. Ofloxacin is rapidly
and completely absorbed from the upper small bowel following oral
administration.
2
D:\FLO040704A.04nonann.wpd
The administration of FLOXIN with food does not significantly affect
the C
max
and AUC
4
of the drug, but Tmax is prolonged.
(See PHARMACOLOGY; HUMAN PHARMACOLOGY; _Factors Influencing the
Pharmacokinetics_; _Food_).
The pharmacokinetic parameters of oral ofloxacin following single
doses of 200, 300, and 400 mg and multiple doses of 400 mg
to healthy 70-80 kg males are summarized below.
Dose
C
max_ _
:
g/mL
± S.D.
AUC
0-last pt.
_ _
:
g x h/mL
± S.D.
T
max
± S.D.
t
1/2
20