NU-CIPROFLOXACIN TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIPROFLOXACIN

Available from:

NU-PHARM INC

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

CIPROFLOXACIN 250MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

QUINOLONES

Product summary:

Active ingredient group (AIG) number: 0123207006; AHFS:

Authorization status:

CANCELLED (UNRETURNED ANNUAL)

Authorization date:

2018-03-28

Summary of Product characteristics

PRODUCT MONOGRAPH
NU-CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE TABLETS
NU
A
PHARM STANDARD
100 MG, 250 MG, 500 MG AND 750 MG
ANTIBACTERIAL AGENT
NU
A
PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
APRIL 07, 2004
RICHMOND HILL, ONTARIO
L4B 1E4
Control #: 067322
- 1 -
PRODUCT MONOGRAPH
NU-CIPROFLOXACIN
(Ciprofloxacin Hydrochloride) Tablets
Nu
A
Pharm Standard
100 mg, 250 mg, 500 mg and 750 mg
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Ciprofloxacin, a synthetic fluoroquinolone, has a bactericidal mode of
action. This action is
achieved through inhibition of DNA gyrase, an essential component of
the bacterial DNA replication
system. Inhibition of the alpha subunit of the DNA gyrase blocks the
resealing of the nicks on the
DNA strands induced by this alpha subunit, leading to the degradation
of the DNA by exonucleases.
This bactericidal activity persists not only during the multiplication
phase, but also during the
resting phase of the bacterium.
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.
Ciprofloxacin
and
metronidazole
have
been
studied
in
combination
and
serum
levels
of
ciprofloxacin are not significantly altered by metronidazole at the
doses studied. Serum levels of
metronidazole when administered orally at a dose of 500 mg q6h in
combination with ciprofloxacin
500 mg PO q12h are: AUC
0-6
156.3 mg
@
h/L, C
MAX
31.3 mg/L and T
MAX
1.71 hours (see HUMAN
PHARMA-COLOGY).
COMPARATIVE BIOAVAILABILITY
A comparative bioavailability study was performed using healthy human
volunteers. The rate and
extent of absorption of ciprofloxacin following administration of a
single (1 x 750 mg tablet) dose
- 2 -
of NU-CIPROFLOXACIN and Cipro
®
were measured and co