NORFLOXACIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NORFLOXACIN

Available from:

AA PHARMA INC

ATC code:

J01MA06

INN (International Name):

NORFLOXACIN

Dosage:

400MG

Pharmaceutical form:

TABLET

Composition:

NORFLOXACIN 400MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

QUINOLONES

Product summary:

Active ingredient group (AIG) number: 0116961001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-02-08

Summary of Product characteristics

Page 1 of 42
PRODUCT MONOGRAPH
PR
NORFLOXACIN
Norfloxacin Tablets, USP
400mg
Antibacterial Agent
AA Pharma Inc.
DATE OF REVISION:
1165 Creditstone Road, Unit#1
June 25, 2019
Vaughan, Ontario
Canada L4K 4N7
Control # 226592
Page 2 of 42
PRODUCT MONOGRAPH
PR
NORFLOXACIN
Norfloxacin Tablets, USP
400 mg
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Norfloxacin is a quinolone carboxylic acid antibacterial agent for
oral administration. Norfloxacin
inhibits bacterial deoxyribonucleic acid synthesis and is
bactericidal.
At the molecular level, three specific actions have been attributed to
norfloxacin in the inhibition of
E.coli cells:
1.
inhibition of the ATP-dependent DNA supercoiling reaction catalyzed by
DNA gyrase,
2.
inhibition of the relaxation of supercoiled DNA,
3.
promotion of double-stranded DNA breakage.
Comparative Bioavailability
A comparative bioavailability study was performed using healthy human
volunteers. The rate and
extent of absorption of norfloxacin following administration of a
single (one 400 mg tablet) dose of
Apo-Norflox and Noroxin were measured and compared. The results are
summarized as follows:
Summary Table of the Comparative Bioavailability Data
Norfloxacin (Dose: 400 mg) From Measured Data
Parameter
Geometric Mean
Arithmetic Mean (CV%)
Ratio of
Geometric
Means (%)**
Apo-Norflox
Noroxin
®
†
AUC
T
(ng•hr/ml)
7480
7870 (32)
7927
8247 (28)
94.3
AUC
I
(ng•hr/ml)
7895
8312 (33)
8367
8708
(28)
94.3
C
max
1501
1597
93.9
Page 3 of 42
Summary Table of the Comparative Bioavailability Data
Norfloxacin (Dose: 400 mg) From Measured Data
Parameter
Geometric Mean
Arithmetic Mean (CV%)
Ratio of
Geometric
Means (%)**
(ng/ml)
1562
(28)
1679
(31)
T
max
(hr)*
1.40
(51)
1.20
(30)
--
t
1/2
(hr)*
5.87
(15)
5.79
(14)
--
*Arithmetic means (CV%).
**Based on the least squares estimate.
†Noroxin
®
is manufactured by Merck, Sharp & Dohme, Div. of Merck Frosst Canada,
and was
purchased in Canada.
INDICATIONS AND CLINICAL USE
The treatment of upper and lower urinary tract i