Product use should be discontinued, and medical advice sought where appropriate, if irritation or rash occurs, or if the condition worsens or does not improve within 7 days.
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 (see section 4.3).
It is important to exclude chronic alternate diagnoses, including chronic otitis media, before treatment is commenced.
Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.
In children there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression, with prolonged use increasing this risk of adrenal suppression in children.
Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.
Due to potentially immature renal function in children toxicity may develop, thus caution is warranted when administering neomycin in this age group.
Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment. This possibility should be considered when high doses or prolonged treatment is given to small children.
There have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, including cases where the patient's aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. While no cases were identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin. These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids
Contains methyl and propyl hydroxybenzoates (E218 and E216) which may cause allergic reactions (possibly delayed).
Contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).