Dexamethasone with glacial acetic acid and neomycin sulfate

§4.1 (therapeutic indications) was not fetched; the indication stated in the dose is taken from §4.4, which describes the product's use where 'otitis externa is treated topically with preparations containing aminoglycosides' and directs that chronic alternative diagnoses, including chronic otitis media, be excluded before treatment is commenced. IN-USE SHELF LIFE (§4.2): use within one month of first use; if there is a period of more than one week since last use, press the actuator down a few times before using again. PERFORATED DRUM: when otitis externa is treated topically with aminoglycoside-containing preparations in patients who have a perforation of the tympanic membrane there is an increased risk of drug-induced deafness, so it is important to ensure there is no perforation. DURATION LIMIT: 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; prolonged use may also lead to skin sensitisation and the emergence of resistant organisms. MITOCHONDRIAL MUTATIONS: an increased risk of ototoxicity has been observed with aminoglycosides in patients with mitochondrial mutations, particularly m.1555A>G, including cases where serum levels were within the recommended range; no cases were identified with neomycin, but based on a shared mechanism of action there is the potential for a similar effect. EXCIPIENTS: contains methyl and propyl hydroxybenzoates (E218 and E216), which may cause allergic reactions (possibly delayed), and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). §4.5 (interactions) was not retrieved — §4.4 was cut off at the source-fetch limit immediately before it.

FIXED DOSE, NOT WEIGHT-BASED — dosePerKg is deliberately null because this SPC gives children 2 years of age and over the same metered dose as adults, not a per-kilogram dose. Do not derive a per-kg figure. §4.2, verbatim: 'Adults (including the elderly) and children 2 years of age and over: ... One metered dose (60mg) to be administered directly into each affected ear three times daily.' UNDER 2 YEARS, verbatim: 'Infants and neonates (under 2 years of age): Dexamethasone/ Neomycin sulfate/ Acetic acid (Otomize) ear spray is not suitable for infants and neonates (see section 4.3)' — and §4.3 lists infants and neonates under 2 years of age as a contraindication. PAEDIATRIC CAUTIONS (§4.4): in children there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression, with prolonged use increasing that risk; due to potentially immature renal function in children, toxicity may develop, so caution is warranted when administering neomycin in this age group; aminoglycosides may cause irreversible, partial or total deafness, an effect that is dose related and enhanced by renal or hepatic impairment, which should be considered when high doses or prolonged treatment are given to small children. Verify against a children's formulary before prescribing.