PHL-CIPROFLOXACIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Verfügbar ab:

PHARMEL INC

ATC-Code:

J01MA02

INN (Internationale Bezeichnung):

CIPROFLOXACIN

Dosierung:

250MG

Darreichungsform:

TABLET

Zusammensetzung:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 250MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100/500

Verschreibungstyp:

Prescription

Therapiebereich:

QUINOLONES

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2004-04-06

Fachinformation

PRODUCT MONOGRAPH
PHL-CIPROFLOXACIN
(CIPROFLOXACIN HYDROCHLORIDE TABLETS, USP)
CIPROFLOXACIN 100 MG
CIPROFLOXACIN 250 MG
CIPROFLOXACIN 500 MG
CIPROFLOXACIN 750 MG
ANTIBACTERIAL AGENT
PHARMEL INC.
Date of Preparation:
8699, 8e Ave
March 23, 2004
Montreal, Quebec
H1Z 2X4
Control # 090462
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PRODUCT MONOGRAPH
NAME
PHL-CIPROFLOXACIN
(ciprofloxacin hydrochloride tablets, USP)
ciprofloxacin 100 mg
ciprofloxacin 250 mg
ciprofloxacin 500 mg
ciprofloxacin 750 mg
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTION 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.
- 3 -
BIOAVAILABILITY AND BIOEQUIVALENCE:
Two bioequivalence studies of Ciprofloxacin Tablets USP have been
conducted and compared to
the reference product, Cipro® of Bayer Inc. purchased in the USA.
The first study was a randomized, 2-way cross-over study comparing the
single-dose relative
bioavailability of the test and reference drugs products (750 mg
ciprofloxacin) under fasting
conditions in healthy volunteers. The results of the study in terms of
the pharmacokinetic
parameters measured are tabulated below.
Analyte Name - ciprofloxacin
Single dose of 750 mg Ciprofloxacin Tablet
From measured and log transf