OFLOXACIN TABLETS

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

OFLOXACIN

Disponibil de la:

AA PHARMA INC

Codul ATC:

J01MA01

INN (nume internaţional):

OFLOXACIN

Dozare:

400MG

Forma farmaceutică:

TABLET

Compoziție:

OFLOXACIN 400MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

QUINOLONES

Rezumat produs:

Active ingredient group (AIG) number: 0122759002; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2016-08-02

Caracteristicilor produsului

0
PRODUCT MONOGRAPH
OFLOXACIN TABLETS
HOUSE STANDARD
200 MG, 300 MG AND 400 MG
ANTIBACTERIAL AGENT
AA PHARMA INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT #1
JULY 20, 2015
VAUGHAN, ONTARIO
L4K 4N7
Control#: 183164
1
PRODUCT MONOGRAPH
OFLOXACIN TABLETS
House Standard
200 mg, 300 mg and 400 mg
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Ofloxacin is 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
duplication, transcription and
repair of bacteria.
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. The
pharmacokinetic parameters of ofloxacin following single doses of 200,
300 and 400 mg and
multiple doses of 400 mg to healthy males are summarized below.
Dose
C
max
µg/mL

S.D.
AUC
0-last point
µg x hr/mL

S.D.
T
max

S.D.
t
½
200 mg -single dose
1.7

0.3
14.1

2.3
1.5

0.3
4.9
300 mg -single dose
2.6

0.4
21.2

2.5
1.7

0.5
4.6
400 mg -single dose
3.7

0.7
31.4

4.7
1.8

0.6
3.8
400 mg -steady state
5.0

1.0
62.9

14.5
1.7

0.5
5.2
Elimination is mainly by renal excretion. Ofloxacin undergoes minimal
biotransformation.
2
Comparative Bioavailability
A comparative bioavailability study was performed using healthy human
volunteers. The rate and
extent of absorption of ofloxacin was measured and compared following
a single oral 400 mg
dose (one 400 mg tablet) of either OFLOXACIN TABLETS or Floxin. The
results from measured
data are summarized as follows:
Geometric Mean
Arithmetic Mean (CV%)
Parameter
OFLOXACIN
TABLETS
Floxin
†
Ratio of
Means (%)*
AUC
T
30.9
31.0
99.5
(µg
•
hr/mL)
31.7 (22)
31.7 (21)
AUC
I
33.3
33.2
100.0
(µg
•
hr/mL)
34.2 (23)
34.1 (22)
C
max
3.75
3.69
102.4
(µg/mL)
3.82