Kenacomb Otic ear drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nystatin, Quantity: 90000 U/mL; triamcinolone acetonide, Quantity: 0.9 mg/mL; gramicidin, Quantity: 0.225 mg/mL; neomycin sulfate (Equivalent: neomycin, Qty 2.25 mg/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Ear Drops, solution

Composition:

Excipient Ingredients: liquid paraffin; polyethylene

Administration route:

Otic

Units in package:

7.5mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of otitis externa (acute and chronic) when a topical corticosteroid is required and active infections with susceptible organisms are either present or likely to supervene

Product summary:

Visual Identification: Oily yellow liquid.; Container Type: Bottle; Container Material: PE; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

KENACOMB OTIC ear drops and ointment - Consumer Medicine Information
Page 1 of 3
KENACOMB OTIC
EAR DROPS AND OINTMENT
_triamcinolone acetonide, neomycin (as sulfate), gramicidin & nystatin
_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
KENACOMB OTIC. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
ALWAYS FOLLOW THE INSTRUCTIONS
THAT YOUR DOCTOR OR PHARMACIST
GIVE YOU ABOUT KENACOMB
OTIC.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE.
DO NOT THROW THIS LEAFLET AWAY.
You may need to refer to it again
later.
WHAT KENACOMB
OTIC IS USED FOR
KENACOMB OTIC is available in
either ear drops or ointment forms
and is used to relieve itching,
burning, pain or inflammation of
the outer ear and ear canal when
it is infected or likely to be
infected. It contains a
combination of medicines:

_triamcinolone acetonide,_
belongs to a class of drugs
called corticosteroids, which
helps to relieve itching,
inflammation and redness.

_neomycin_, is an antibacterial
medicine

_gramicidin, _is an antibacterial
medicine.

_nystatin,_ is an antifungal drug.
It is used to prevent or treat a
particular type of fungal
infection called _Candida _
_albicans_.
Your doctor will need to look
inside your ears, especially at
your eardrums and may have to
clean your ears before prescribing
this medicine.
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.
KENACOMB OTIC is only
available on prescription from
your doctor.
_USE IN CHILDREN _
_ _
KENACOMB OTIC should be
used carefully in children. Long
term use can cause systemic side
effects through absorption of
KENACOMB OTIC.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE KENACOMB OTIC IF
YOU HAVE AN ALLERGY TO:

any medicine containing
nystatin, neomycin,
gramicidin, triamcinolone
acetonide

any of the ingredi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT
I
NFO
R
MAT
I
O
N
KENACOMB OTIC
(TRIAMCINOLONE ACETONIDE, NYSTATIN, NEOMYCIN (AS SULFATE) AND
GRAMICIDIN)
OINTMENT AND EAR DROPS
1
NAME OF THE MEDICINE
Triamcinolone acetonide; nystatin; neomycin (as sulfate) and
gramicidin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ointment:
Each gram of KENACOMB OTIC ointment provides triamcinolone acetonide 1
mg,
neomycin (as sulfate) 2.5 mg, gramicidin 0.25 mg and nystatin 100,000
IU.
Ear drops:
Each mL of KENACOMB OTIC ear drops provides triamcinolone acetonide
0.9 mg,
neomycin (as sulfate) 2.25 mg, gramicidin 0.225 mg and nystatin 90,000
IU.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ointment:
A yellow to amber coloured ointment.
Ear drops:
Oily yellow liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
KENACOMB OTIC is indicated for the treatment of otitis externa (acute
and chronic) when a topical
corticosteroid is required and active infections with susceptible
organisms are either present or likely to
supervene.
KENACOMB OTIC is only recommended for short-term use.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Prior to administration of any KENACOMB preparation, all wax and
epithelial debris should be removed
and the tympanic membrane inspected.
Ointment:
Apply to the external auditory meatus (and external ear if required)
two or three times
daily.
Ear drops:
2 or 3 drops should be instilled into the ear two or three times
daily. Alternatively, a
gauze wick kept saturated with the drops may be inserted into the
external auditory
meatus.
4.3
C
ONTRAINDICATIONS
2
Tuberculous lesions and topical or systemic viral infections such as
Herpes simplex, but particularly in
VACCINIA and VARICELLA.
In the treatment of otitis media or in the presence of a perforate
tympanic membrane.
Known hypersensitivity to triamcinolone, neomycin, nystatin,
gramicidin or any other component of the
preparation.
Ophthalmic use.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
If sensitivity or irritation develops, use of t