Hydrocortisone with neomycin and polymyxin B

UK SPC (Otosporin Ear Drops) section 4.2, verbatim: 'Otosporin ear drops are for topical administration into the ear only. Adults Following cleansing and drying of the external auditory meatus and canal as appropriate, three drops should be instilled into the affected ear three or four times daily. Alternatively, a gauze wick may be introduced into the external auditory canal and kept saturated with the solution; the wick may be left in place for 24 to 48 hours. Treatment should not be continued for more than 7 days without medical supervision. Soap should not be used for cleansing of the external auditory meatus and canal as it may inactivate the antibiotics.' SOAP: do not use soap to cleanse the meatus and canal - it may inactivate the antibiotics. ELDERLY: 'As for adults. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulphate may occur.' RENAL IMPAIRMENT: 'Dosage should be reduced in patients with reduced renal function' - the SPC gives no numeric reduced regimen, so none is stated here. SEVEN-DAY LIMIT: section 4.4 adds that treatment with topical steroid/antibiotic combinations should not be continued for more than seven days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infection due to the masking effect of the steroid, to skin sensitisation and to emergence of resistant organisms. ADMINISTRATION ERRORS: accidental maladministration, prescription and dispensing errors have been reported - particular care should be taken to ensure the correct formulation has been provided and administered. SCOPE CAVEAT: sections 4.2, 4.3, 4.6 and 4.8 were captured in full; section 4.4 was cut at the source-fetch limit part-way through the aminoglycoside/mitochondrial-mutation paragraph, so the warnings list below is not complete - consult the full SPC.

NOT WEIGHT-BASED - this is a topical otic drop, so dosePerKg is deliberately left null and the weight calculator is unset. Section 4.2 verbatim: 'Children Otosporin Ear Drops are suitable for use in children ( 3 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Otosporin Ear Drops are not recommended in neonates and infants (<3 years).' Section 4.3 repeats this as a contraindication and explains why: 'In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.' Section 4.4 adds that development of adverse systemic effects from the hydrocortisone component is considered unlikely, 'although the recommended dosage should not be exceeded, particularly in infants.' Verify against a children's formulary before use.