CILOXAN ciprofloxacin 3mg/mL (as hydrochloride) ear drops

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride, Quantity: 3.5 mg/mL (Equivalent: ciprofloxacin, Qty 3 mg/mL)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

ciprofloxacin hydrochloride

Pharmaceutical form:

Ear Drops, solution

Composition:

Excipient Ingredients: mannitol; purified water; benzalkonium chloride; sodium hydroxide; disodium edetate; sodium acetate; hydrochloric acid; glacial acetic acid

Administration route:

Otic

Units in package:

2.5mL, 1mL (sample pack), 5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of chronic suppurative otitis media caused by organisms susceptible to ciprofloxacin in adults and children one month of age or older.

Product summary:

Visual Identification: Colourless to pale yellow solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-05-17

Patient Information leaflet

CILOXAN
®
_0.3% EAR DROPS_
_ciprofloxacin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Ciloxan Ear Drops.
This leaflet answers some common
questions about Ciloxan Ear Drops. It
does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine.
You can also download the most up
to date leaflet from
www.novartis.com.au.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
Ciloxan Ear Drops against the risks
this medicine could have for you.
The information in this leaflet applies
to Ciloxan only. This information
does not apply to similar products,
even if they contain the same
ingredients.
If you have any concerns about using
this medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CILOXAN IS USED
FOR
Ciloxan is used to treat certain types
of ear infections caused by bacteria.
Your doctor will usually prescribe
this medicine because you have a
middle ear infection.
Ciloxan contains ciprofloxacin
hydrochloride, an antibiotic that
belongs to a group of medicines
called fluoroquinolones. This
antibiotic works by killing the
bacteria that are causing your
infection.
Ciloxan will not work against
infections caused by viruses, such as
colds or the flu, or infections caused
by fungus.
Before prescribing Ciloxan, the
doctor will have examined your
ear(s) and decided that Ciloxan is the
right medicine for you.
Your doctor may have prescribed
Ciloxan for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS ME

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – CILOXAN (CIPROFLOXACIN
HYDROCHLORIDE) EAR DROPS
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CILOXAN Ear Drops contain ciprofloxacin hydrochloride (equivalent to 3
mg/mL ciprofloxacin base).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CILOXAN Ear Drops is a sterile, multiple-dose product, for topical
otic use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of chronic suppurative otitis media (CSOM) when caused by
organisms susceptible to
ciprofloxacin in adults and children 1 month or older.
4.2
D
OSE AND METHOD OF ADMINISTRATION
CHRONIC SUPPURATIVE OTITIS MEDIA (ADULTS AND CHILDREN 1 MONTH OR
OLDER). The recommended
dosage is: five (5) drops into the affected ear canal(s) twice daily
for 9 days.
If the solution is cold, it should be warmed by holding the bottle in
the hand for one or two minutes
before instillation, to avoid dizziness which may be associated with
instillation of a cold solution into
the ear.
Patients should be advised to avoid contamination of the dispensing
tip.
4.3
C
ONTRAINDICATIONS
A history of hypersensitivity to ciprofloxacin or any other component
of the medication
.
A
history of
hypersensitivity to other quinolones, including nalidixic acid, may
also contraindicate the topical use
of ciprofloxacin.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL USE ONLY - NOT FOR INJECTION
FOR OTIC USE ONLY
IDENTIFIED PRECAUTIONS
CILOXAN Ear Drops should be discontinued at the first appearance of a
skin rash or any other sign of
hypersensitivity. Serious and occasionally fatal hypersensitivity
(anaphylactic) reactions, some
2
following the first dose, have been reported in patients receiving
systemic quinolones. Some
reactions were accompanied by cardiovascular collapse, loss of
consciousness, tingling, pharyngeal
or facial oedema, dyspnoea, urticaria, and itching. Only a few
patients had a history of
hypersensitivity reactions. Serious anaphylacti