OTODEX EAR DROPS dexamethasone (as sodium metasulfobenzoate) framycetin sulfate gramicidin 8 mL bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dexamethasone, Quantity: 0.5 mg/mL; framycetin sulfate, Quantity: 5 mg/mL; gramicidin, Quantity: 0.05 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Ear Drops

Composition:

Excipient Ingredients: phenethyl alcohol; polysorbate 80; citric acid monohydrate; sodium citrate dihydrate; lithium chloride; purified water; industrial methylated spirit; sodium hydroxide; hydrochloric acid

Administration route:

Otic

Units in package:

8ml

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 22 MARCH 1993: Inflammatory and allergic conditions of the ear, e.g. otitis externa. Eczema of the auditory meatus is often present and causes inflammation, exudation and pruritus, which are all rapidly relieved by dexamethasone. Infection,often secondary to scratching, is generally due to staphylococci, E. coli, Pseudomonas and Proteus spp. which respond rapidly to framycetin.

Product summary:

Visual Identification: A clear bright colourless aqueous solution.; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-04-01

Patient Information leaflet

OTODEX
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING OTODEX?
Otodex contains the active ingredients framycetin sulfate, gramicidin
and dexamethasone. Otodex is used to treat infection
or inflammation of the ear. Otodex contains antibiotics (framycetin
sulfate and gramicidin) to kill germs and a corticosteroid
(dexamethasone) to stop inflammation, itching and weeping.
For more information, see Section 1. Why am I using Otodex? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OTODEX?
Do not use if you have ever had an allergic reaction to Otodex or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Otodex? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Otodex and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE OTODEX?
•
Generally Otodex drops are used 3 or 4 times daily
•
To use, tilt your head so that the affected ear is uppermost. Position
the rubber dropper directly above the ear hole. With the
bottle tipped upside down, gently squeeze the rubber dropper until 2
or 3 drops fall into the ear. Keep your head tilted for about
a minute to allow the drops to penetrate deep into the ear.
More instructions can be found in Section 4. How do I use Otodex? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OTODEX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Otodex.
•
Use Otodex only in the ear unless your doctor advises differently.
•
If you become pregnant while using Otodex, stop using it and tell your
doctor or pharmacist immediately.
THINGS YOU
SHOU

Summary of Product characteristics

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Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION – OTODEX (FRAMYCETIN
SULFATE, GRAMICIDIN AND DEXAMETHASONE (AS SODIUM
METASULFOBENZOATE))
1
NAME OF THE MEDICINE
Framycetin sulfate, gramicidin and dexamethasone (as sodium
metasulfobenzoate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains framycetin sulfate 5mg, gramicidin 50µg and
dexamethasone (as sodium
metasulfobenzoate) 500µg.
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Otodex is a clear bright colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inflammatory and allergic conditions of the ear, e.g. otitis externa.
Eczema of the auditory
meatus is often present and causes inflammation, exudation and
pruritus, which are all
rapidly relieved by dexamethasone. Infection, often secondary to
scratching, is generally due
to staphylococci,
_E. coli_
,
_Pseudomonas_
and
_Proteus spp_
. which respond rapidly to framycetin
sulfate.
4.2
DOSE AND METHOD OF ADMINISTRATION
2 or 3 drops should be instilled into the ear three or four times
daily; alternatively, a gauze
wick kept saturated with the drops may be inserted into the external
auditory meatus.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substances (see Section 2 Qualitative
and quantitative
composition) or to any of the excipients listed in Section 6.1 List of
excipients;
•
viral and fungal infections;
•
tubercular lesions;
•
varicella, vaccinia;
oto-ccdsv2-piv9-02jun22
Page 2 of 8
•
eardrum perforation;
•
acute purulent, untreated infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Otodex should be discontinued if there are signs of sensitivity to any
of its ingredients.
Treatment with corticosteroid/antibiotic combinations should not be
continued in the absence
of clinical improvement, since prolonged use may lead to occult
extension of infections due
to the masking effect of the steroid. Prolonged use may also lead to
skin sensitisation and the
emergence of resistant organisms.
In p