Otomize

1. Name Of The Medicinal Product

Otomize

2. Qualitative And Quantitative Composition

Neomycin Sulphate 0.5% w/w (3250 IU/ml)

Dexamethasone 0.1% w/w

Glacial Acetic Acid 2.0% w/w

For excipients see 6.1.

3. Pharmaceutical Form

A milky oil-in-water emulsion as a liquid ear spray for application into the external auditory meatus

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of otitis externa

4.2 Posology And Method Of Administration

Topical spray directly into the ear.

Adults, children and the elderly: one metered dose (60mg) to be administered directly into each affected ear three times daily. Treatment should be continued until two days after symptoms have disappeared. Discontinue treatment if there is no clinical improvement after 7 days.

4.3 Contraindications

Hypersensitivity to neomycin sulphate, dexamethasone, glacial acetic acid or to any of the excipients.

The product should not be used in patients where a perforated tympanic membrane has been diagnosed or is suspected or where a tympanostomy tube (grommet) is in situ.

4.4 Special Warnings And Precautions For Use

The CSM has warned that when otitis externa is treated topically with preparations containing aminoglycosides, in patients who have a perforation of the tympanic membrane, there is an increased risk of drug induced deafness. It is therefore important to ensure that there is no perforation in such patients. However, in the presence of a perforation many specialists do use such agents cautiously in patients with otitis media.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7 Effects On Ability To Drive And Use Machines

Unresolved ear problems could themselves affect driving ability.

4.8 Undesirable Effects

Some patients may experience a transient stinging or burning sensation for the first few days of treatment.

4.9 Overdose

Overdosage by this route is extremely unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Neomycin sulphate is an established antibiotic with a well characterised broad spectrum of activity. Dexamethasone is a well established topical anti-inflammatory steroid. Acetic acid functions to produce a low pH to assist in the control of bacterial infection.

5.2 Pharmacokinetic Properties

Otomize ear spray is applied topically to the external auditory meatus and acts locally.

The spray provides excellent distribution and coverage of the surface.

5.3 Preclinical Safety Data

No additional data of relevance

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol (2) Stearyl Ether

Macrogol (20) Stearyl Ether

Stearyl Alcohol

Methyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf Life

Shelf life in the product as packaged for sale: 18 months from the date of manufacture.

Shelf life after first opening of the container: use within one month of first use.

6.4 Special Precautions For Storage

Store upright in a carton. Do not store above 25°C. Do not freeze.

6.5 Nature And Contents Of Container

The product is supplied in an amber glass bottle of 5ml capacity fitted with a spray device.

6.6 Special Precautions For Disposal And Other Handling

Shake the bottle well before use. Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray.

Administer spray directly by gently placing nozzle tip into ear opening and pressing down once on the actuator. Use within one month of first use. If there is a period of more than one week since last use, press actuator down a few times before using again.

7. Marketing Authorisation Holder

Stafford Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as GlaxoSmithKline Consumer Healthcare, Brentford TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00036/0042

9. Date Of First Authorisation/Renewal Of The Authorisation

05/10/1989 / 25/08/2006

10. Date Of Revision Of The Text

01/12/2009