CIPROFLOXACIN AN 250mg ciprofloxacin (as hydrochloride) 250 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride, Quantity: 294.586 mg (Equivalent: ciprofloxacin, Qty 250 mg)

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

ciprofloxacin hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

60, 28, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: Urinary tract infections; Gonorrhoeal urethritis and cervicitis; Gastroenteritis; Bronchial Infections; Skin and skin structure infections; Bone and joint infections; Chronic bacterial prostatitis of mild to moderate severity. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. Note: Typhoid and Paratyphoid infections and infections due to multi-resistant Staphylococcus aureus are excluded from the above due to insufficient data. Because Gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with Ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both Gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

Product summary:

Visual Identification: White to off-white, round, film coated tablets, with a score line on one side & debossed with F & 23 with a score line in between on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-12-16

Patient Information leaflet

_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

Summary of Product characteristics

_Ciprofloxacin AN tablets Product Information _
_ _
_Amneal Pharma Pty Ltd_
Doc ID: 49.AN.P.2.0
Page 1 of 17
CIPROFLOXACIN AN
_ _
_(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