C-FLOX 250 TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE

Available from:

JETPHARMA SDN. BHD.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Units in package:

100Tablet Tablets

Manufactured by:

INTAS PHARM LTD

Patient Information leaflet

Not Applicable/ None

Summary of Product characteristics

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory.
C-FLOX 250 & 500
(Ciprofloxacin tablets 250 mg & 500 mg)
C-flox
(Ciprofloxacin)
is
a
broad
spectrum
and
potent
synthetic
fluoroquinolone antibacterial agent. It is indicated in various
respiratory,
urinary and other infections caused by susceptible microorganisms.
DESCRIPTION: C-flox 250: White to off white coloured, round, biconvex,
film
coated tablet plain on one side and bisecting line on other side of
the tablet.
C-flox 500: White to off white coloured, capsule shaped, biconvex,
film
coated tablet with break line on one side of the tablet.
CLINICAL PHARMACOLOGY: Ciprofloxacin exhibits potent bactericidal
action
by Interfering with enzyme DNA gyrase -which is needed for the
synthesis
of bacterial DNA. The in vitro antimicrobial spectrum of Ciprofloxacin
includes wide range of microorganisms including Gram-negative bacteria
like
campylobacter
jejuni,
E.coli,
Citrobacters,
H.influenzae,
H.parainffuenzae,
Shigella,
Salmonella
typhi,
Vibrio
cholerae,
Neisseria-gonorrhoea,
N.meningitidis,
Branhaemella
catanrhalis,
Kleb.pneumoniae,
Brucella
melitensis,
H.ducrayi,
Proteus
mirabilis,
P.vulgaris,
Pseudomonas
aeruginosa,
Providancia
rettgeri,
P.
startii,
Serratia marcescens, Enterobacter cloacae, and Gram-positive bacteria
like
Staphylococcus
aureus,
Staph.
epidermidis,
Staph.haemolyticus,
Streptococcus pneumoniae, Streptococcus pyogens. ..; Most strains of
Ps.
cepacia,
Ps.multophilia
and
most
anaerobic
bacteria
are
resistant
to
Ciprofloxacin.Ciprofloxacin is slightly less active at acidic pH.
Ciprofloxacin
does not cross- react with other antimicrobial agents. Synergism is
reported
with
aminoglycosides,
clindamycin,
metronidazole
and
particularly
beta-lactams. Ciprofloxacin is also shown to have post antibiotic
effect
(PAE)
i.e.
continued
antibacterial
effect
after
cessation
of
drug
administration.
Ciprofloxacin
is
rapidly
and
well
absorbed
from
the
gastrointestinal tract. Oral bioavailability is about 70% and a peak
plasma
concentration of