CIPROX TABLET 250MG

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

CIPROFLOXACIN HCL

Dostopno od:

APEX PHARMACY MARKETING SDN. BHD.

INN (mednarodno ime):

CIPROFLOXACIN HCL

Enote v paketu:

100Tablet Tablets

Izdeluje:

DELORBIS PHARMACEUTICALS LTD.

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CIPROX TABLET
_ _
Ciprofloxacin (250mg & 500mg)
1
WHAT IS IN THIS LEAFLET
1. What Ciprox is used for
2. How it works
3. Before you use Ciprox
4. How to use Ciprox
5. While you are using it
6. Side effects
7. Storage and disposal of
Ciprox
8. Product description
9. Manufacturer
10. Product registration holder
11. Date of revision
12. Serial number
WHAT CIPROX IS USED FOR
CIPROX is used to treat the
following bacterial infections:

Uncomplicated and
complicated infections
caused by ciprofloxacin-
sensitive pathogens.

Infections of the
respiratory tract.

In the treatment of
outpatients with
pneumonia due to
Pneumococcus,
ciprofloxacin should not
be used as a first choice
of drug. Ciprofloxacin
can be regarded as an
advisable treatment for
pneumonias caused by
Klebsiella, Enterobacter,
Proteus, E. coli,
Pseudomonas,
Haemophilus,
Branhamella, Legionella
and Staphylococcus.

Infections of the middle
ear (otitis media), of the
paranasal sinuses
(sinusitis), especially if
these are caused by gram-
negative organisms
including Pseudomonas
or by Staphylococcus.

Infections of the eyes.

Infections of the kidneys
and/or the efferent urinary
tract.

Infections of the genital
organs, including
adnexitis, gonorrhoea,
prostatitis.

Infections of the
abdominal cavity (eg,
infections of the
gastrointestinal tract or of
the biliary tract,
peritonitis).

Infections of the skin and
soft tissue.

Infections of the bones
and joints.

Sepsis.

Infections or imminent
risk of infection
(prophylaxis) in patients
whose immune system
has been weakened (eg,
patients on
immunosuppressants or
have neutropenia).
HOW IT WORKS
CIPROX
is
an
antibiotic
belonging
to
the
fluoroquinolone
family.
The
active
substance
is
ciprofloxacin.
Ciprofloxacin
works by killing bacteria that
cause infections. It only works
with specific strains of bacteria.
BEFORE YOU USE CIPROX
_- When you must not use it _
DO NOT TAKE CIPROX IF YOU
ARE:

allergic
(hypersensitive)
to
the

Lastnosti izdelka

COMPOSITION
Each tablet contains equivalent to Ciprofloxacin
250 mg
Each tablet contains equivalent to Ciprofloxacin
500 mg
PRODUCT DESCRIPTION
White oblong, 14.3 x 6.3 mm, film coated tablet,
scored on both side
White oblong, 17.3 x 8.3 mm, film coated tablet,
scored on both side
PHARMACODYNAMICS
Ciprofloxacin is a synthetic 4-quinolone derivative,
with bactericidal activity. It acts via inhibition of
bacterial
DNA
gyrase,
ultimately
resulting
in
interference with DNA function. Ciprofloxacin is
highly active against a wide range of Gram-positive
and Gram-negative organisms and has shown
activity against some anaerobes, Chlamydia spp.
and Mycoplasma spp. Ciprofloxacin is also suitable
for
use
in
combination
with
penicillins,
cephalosporins, aminoglycosides and tetracyclines
where additive behaviour is usually observed.
PHARMACOKINETICS
Absorption of ciprofloxacin occurs rapidly, mainly
from the small intestine (Abs. T1/2 = 2-15 min).
Plasma levels are dose-related and peak 0.5-2.0 hrs
after
dosing.
The
AUC
also
increases
dose
proportionately after administration of both single
and repeated oral doses. The oral bioavailability is
approximately
70-80%.
Distribution
of
ciprofloxacin
within
tissues
is
wide
and
the
volume
of
distribution
high,
though
slightly
lower in the elderly.
Protein
binding
is
low
(between
19-40%).
Elimination of ciprofloxacin and its metabolites
occurs rapidly, primarily by the kidney. After single
dose of ciprofloxacin, 55% are eliminated by the
kidney and 39% in the faeces within 5 days. The
elimination half-life of unchanged ciprofloxacin
over a period of 24 - 48 hrs post dose is 3.1-5.1 hrs.
Even though, studies with severely renally impaired
patients (creatinine clearance < 20ml/minute) do not
give clear indications, it is recommended to reduce
by half the total daily dose.
Results of studies in paediatric cystic fibrosis
patients have shown dosages of 20 mg/kg orally
twice daily is recommended to achieve plasma
concentration/time profiles comparable to those
achieved in the adult populati