CIPROXIN

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

CIPROFLOXACIN LACTATE

Available from:

BAYER INDONESIA - Indonesia

INN (International Name):

CIPROFLOXACIN LACTATE

Dosage:

508.8 MG

Pharmaceutical form:

INFUS

Units in package:

DUS, 1 BOTOL @ 200 ML

Manufactured by:

BAYER AG - Federal Republic of Germany

Authorization date:

2020-04-04

Summary of Product characteristics

Ciproxin
®
400mg/200mL/Ciprofloxacin/Infus/New Site Fresenius Kabi - BEC
14462&13271
1
CIPROXIN
®
INFUSION SOLUTION
Important information, please read carefully! COMPOSITION
Ciproxin
®
0.4 g: 1 vial of 200 ml infusion solution contains 400 mg
ciprofloxacin. PROPERTIES
Pharmacotherapeutic group: Fluoroquinolones
ATC Code: J01MA02
Ciprofloxacin is a new substance developed by Bayer AG belon ging to
the quinolone carboxylic acid group. The substan ce
has a good bactericidal effect against a broad spectrum of bacteria.
MECHANISM OF ACTION
The bactericidal action of ciprofloxacin results from inhibition of
bacterial type II topoisomerases (DNA g yrase and
topoisomerase IV), which are required for bacterial DNA replication,
transcription, repair, and recombination
MECHANISM OF RESISTANCE
_In-vitro _resistance to ciprofloxacin can be acquired through a
stepwise process by target site mutations in both DNA g yrase
and topoisomerase IV. The degree of cross-resistance between
ciprofloxacin and other fluoroquinolones that results is
variable. Single mutations may not result in clinical resistance, but
multiple mutations generally result in clinical resistance to
many or all active substances within the class.
Impermeability and/or active substance efflux pump mechanisms of
resistance may have a variable effect on suscepti bi l i ty
to fluoroquinolones, which depends on the physiochemical properties of
the vario us active substances within the class an d
the affinity of transport systems for each active substance. All
_in-vitro _mechanisms of resistance are commonly observed i n
clinical isolates. Resistance mechanisms that inactivate other
antibiotics such as permeation barriers (common in
_Pseudomonas aeruginosa_) and efflux mechanisms may affect
susceptibility to ciprofloxacin.
Plasmid-mediated resistance encoded by qnr-genes has been reported.
The bacterial genus and species listed below have been shown to
commonly be susceptible to ciprofloxacin in vitro:
AEROBIC GRAM-POSITIVE MICROORGANISMS
_Bacillus anthracis _
_St