CIPROXIN 500 ciprofloxacin 500 mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride, Quantity: 583 mg (Equivalent: ciprofloxacin, Qty 500 mg)

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; maize starch; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose; macrogol 4000; titanium dioxide

Administration route:

Oral

Units in package:

60, 14, 4 and 2

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the following 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 Ciproxin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciproxin 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 biconvex, 18mm x 8mm oblong tablet with "Bayer" on one side; "CIP" and "500" on the other side separated by a score across the width of the tablet.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1992-03-02

Patient Information leaflet

CIPROXIN TABLETS CMI VX1.0
1
CIPROXIN
® TABLETS
(CI·PROX·IN)
_ciprofloxacin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Ciproxin 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 Ciproxin
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 CIPROXIN IS
USED FOR
Ciproxin tablets are used for the
treatment of infections of the lungs,
skin, bones, joints, kidneys, bladder,
prostate and bowel. Ciproxin is also
used to treat inhalational anthrax
(an infection caused by breathing in
the spores of bacteria).
Ciproxin 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.
Ciproxin 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
CIPROXIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CIPROXIN IF YOU HAVE
AN ALLERGY TO:
•
ciprofloxacin, the active
ingredient in Ciproxin
•
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 of the
body
•
rash, itching or hives on the
skin.
DO NOT TAKE CIPROXIN IF YOU ARE
ALSO TAKING A MEDICINE CALLED
TIZANIDINE, A MUSCLE RELAXANT USED
TO TREAT SPAS

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CIPROXIN® (CIPROFLOXACIN) TABLETS
Ciproxin® PI VX1.0; CCDS 20
Page 1 of 19
1 NAME OF THE MEDICINE
Ciprofloxacin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciproxin is available as 250 mg, 500 mg and 750 mg film-coated tablets
for oral administration.
Ciproxin 250 contains 250mg of active, Ciproxin 500 contains 500mg of
active, and Ciproxin 750
contains 750mg of active.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Ciproxin 250 – Biconvex, white film-coated tablet round tablet 11mm
in diameter containing 250 mg
ciprofloxacin, the top scored and marked with "CIP” on one half of
the score and “250" on the other
half and the Bayer cross on bottom.
Ciproxin 500 – Biconvex, oblong 18mm x 8mm, white film-coated tablet
containing 500 mg
ciprofloxacin, the top scored and marked with "CIP and 500" on the
other side separated by a score
across the width of the tablet and "BAYER" on bottom.
Ciproxin 750 – Biconvex, 22mm x 8mm oblong, white film-coated tablet
containing 750 mg
ciprofloxacin, and marked with "CIP 750" on top and "BAYER" on bottom.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciproxin 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:
1.
Typhoid and Paratyphoid infections and infections due to
multi-resistant _ Staphylococcus _
_aureus_ are excluded from the above due to insufficient data.
Ciproxin® PI VX1.0; CCDS 20
Page 2 of 1