AURO-CIPROFLOXACIN 750 ciprofloxacin (as hydrochloride) 750 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride, Quantity: 883.758 mg (Equivalent: ciprofloxacin, Qty 750 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

ciprofloxacin hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

28, 60, 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, capsule shaped, film coated tablets debossed with 'C' on one side and '93' 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:

Licence status A

Authorization date:

2011-12-16

Patient Information leaflet

AURO-CIPROFLOXACIN
CONSUMER MEDICINE INFORMATION
Ver 1.2
Page 1 of 4
AURO-CIPROFLOXACIN 250, 500 & 750
Ciprofloxacin (as hydrochloride)
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
AURO-
CIPROFLOXACIN 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
AURO-
CIPROFLOXACIN
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
AURO-CIPROFLOXACIN IS USED FOR
AURO-CIPROFLOXACIN
tablets
are
used
for
the
treatment
of
infections of the lungs, skin, bones,
joints, kidneys, bladder, prostate and
bowel.
AURO-CIPROFLOXACIN
is
also
used
to
treat
inhalational
anthrax
(an
infection
caused
by
breathing in the spores of bacteria).
AURO-CIPROFLOXACIN
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.
AURO-CIPROFLOXACIN 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
AURO-CIPROFLOXACIN
WHEN YOU MUST NOT TAKE IT
DO
NOT
TAKE
AURO-
CIPROFLOXACIN IF YOU HAVE AN
ALLERGY TO:
•
ciprofloxacin,
the
active
ingredient
in
AURO-
CIPROFLOXACIN
•
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 other parts