Anti-infectives combined with a corticosteroid in ear drop solution: AURICULARUM (oxytetracycline, polymyxin B, nystatin, dexamethasone)
Reason for request
Low clinical benefit for the treatment of acute otitis externa
These medicinal products have been granted a marketing authorisation for the topical treatment of bacterial acute otitis externa. Proprietary medicinal products containing an amino sugar (ANTIBIO SYNALAR, FRAMYXONE, PANOTILE and POLYDEXA) are restricted to the treatment of acute otitis externa with a closed tympanum. Also, AURICULARUM has also been granted a marketing authorisation for the topical treatment of bacterial and/or fungal acute otitis externa.
The efficacy in obtaining clinical recovery from acute otitis externa is not the subject of relevant evidence for these fixed antibiotic + corticosteroid combinations, with the exception of CILOXADEX.
The benefit of combining a corticosteroid with the topical antibiotic treatment for the treatment of acute otitis externa has not been demonstrated for any of these medicinal products.
Given the long follow-up period of use in particular, the higher risk of antibiotic resistance with fluoroquinolones and the lack of alternatives containing a non-fluoroquinolone antibiotic and not combined with a corticosteroid, they retain a low clinical benefit.
CILOXADEX should be used as a second-line treatment due to the higher risk of antibiotic resistance with fluoroquinolones or in cases of an open tympanum or previous history of tympanic perforation. The role of AURICULARUM in the therapeutic strategy for otitis externa is limited; it should be reserved for acute otitis externa of fungal or combined fungal and bacterial origin.