For the treatment of otitis externa
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.
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.
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
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.
Effects on ability to drive and use machines
Unresolved ear problems could themselves affect driving ability.
Some patients may experience a transient stinging or burning sensation for the first few days of treatment
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