OFLOXACIN TABLETS

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

OFLOXACIN

Tillgänglig från:

AA PHARMA INC

ATC-kod:

J01MA01

INN (International namn):

OFLOXACIN

Dos:

400MG

Läkemedelsform:

TABLET

Sammansättning:

OFLOXACIN 400MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

QUINOLONES

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2016-08-02

Produktens egenskaper

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