CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

ciprofloxacin hydrochloride

Предлага се от:

Amneal Pharma Australia Pty Ltd

INN (Международно Name):

ciprofloxacin hydrochloride

Статус Оторизация:

Registered

Листовка

_Ciprofloxacin AN tablets – Consumer Medicine Information _
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_Ciprofloxacin AN CMI v2.0 _
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_Page 1 _
CIPROFLOXACIN AN TABLETS
_Ciprofloxacin(as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CIPROFLOXACIN AN tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
CIPROFLOXACIN
AN
tablets
against the benefits they expect
it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
CIPROFLOXACIN AN
IS USED FOR
CIPROFLOXACIN
AN
tablets
are
used
for
the
treatment
of
infections
of
the
lungs,
skin,
bones, joints, kidneys, bladder,
prostate
and
bowel.
CIPROFLOXACIN
AN
is
also
used to treat inhalational anthrax
(an
infection
caused
by
breathing
in
the
spores
of
bacteria).
CIPROFLOXACIN
AN
tablets
contain
the
active
ingredient,
ciprofloxacin,
which
is
an
antibiotic belonging to a group of
medicines
called
quinolones
(pronounced
kwin-o-lones).
These antibiotics work by killing
the
bacteria
that
are
causing
your infection.
CIPROFLOXACIN
AN
will
not
work against infections caused
by viruses such as colds or the
flu.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your
doctor
may
have
prescribed it for another reason.
BEFORE YOU TAKE
CIPROFLOXACIN AN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE CIPROFLOXACIN
AN IF YOU HAVE AN ALLERGY TO:

ciprofloxacin,
the
active
ingredient
in
CIPROFLOXACIN AN

any of the ingredients listed
at the end of this leaflet

other
medicines
belonging
to
the
quinolone
chemical
family
(e.g.
moxifloxacin,
norfloxacin, nalidixic acid).
Some
of
the
symptoms
of
an
allergic reaction may include:

shortness of breath

wheezing
or
difficulty
breathing

swelling
of
the
face,
lips,
tongue or

Данни за продукта

_Ciprofloxacin AN tablets Product Information _
_ _
_Amneal Pharma Pty Ltd_
Doc ID: 49.AN.P.2.0
Page 1 of 17
CIPROFLOXACIN AN
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_(CIPROFLOXACIN HYDROCHLORIDE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is ciprofloxacin as ciprofloxacin
hydrochloride.
O
O
F
OH
.
HCL
N
N
HN
CHEMICAL NAME:
1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-
carboxylic acid hydrochloride
MOLECULAR FORMULA: C
17
H
19
ClFN
3
O
3
MOLECULAR WEIGHT: 367.8
CAS REGISTRY NUMBER: _[93107-08-5]_
DESCRIPTION
Ciprofloxacin hydrochloride is a pale yellow crystalline powder,
slightly hygroscopic. It is
soluble in water, slightly soluble in methanol, very slightly soluble
in ethanol, practically
insoluble in acetone, in ethyl acetate and in methylene chloride.
CIPROFLOXACIN
AN
is
available
as
tablets
containing
250
mg,
500
mg
&
750
mg
ciprofloxacin (as hydrochloride).
CIPROFLOXACIN
AN tablets
contain
the
following
inactive
ingredients:
m icrocrystalline
cellulose, sodium starch glycollate type A, povidone, colloidal
anhydrous silica, magnesium
stearate, hypromellose, macrogol 400 & titanium dioxide.
PHARMACOLOGY
Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative
with broad spectrum
antimicrobial activity. Ciprofloxacin is rapidly and well absorbed
from the gastrointestinal tract
after oral administration. The absolute bioavailability is
approximately 70% with no substantial
loss by first pass metabolism. Serum concentrations increase in a
dose-proportional manner and
were, after multiple doses, as shown below:
Dose (mg)
Maximum Serum
Concentration (μg/mL)
Area Under Curve (AUC)
(μg.hr/mL)
250
1.4
5.4
500
2.6
10.6
750
3.4
15.0
_Ciprofloxacin AN tablets Product Information _
_ _
_Amneal Pharma Pty Ltd_
Doc ID: 49.AN.P.2.0
Page 2 of 17
Maximum serum concentrations are attained 1 to 2 hours after oral
dosing. Mean concentrations
12 hours after dosing with 250, 500 or 750 mg are 0.1, 0.2 and 0.4
μg/mL respectively. The
serum elimination half-life in subjects with normal re