Cetraxal Plus Special Precautions

This medicinal product is for auricular use only, not for ophthalmic use, inhalation or injection. This medicine should not be swallowed or injected.
If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumour. If after the treatment some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment.
Cetraxal Plus should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.
As with other antibiotic preparations, the use of this product may result in overgrowth of non-susceptible organisms, including bacterial strains, yeast and fungi. If superinfection occurs, appropriate therapy should be initiated.
Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to sun. Due to the site of administration, it is unlikely that this product may produce photoallergic reactions.
Corticosteroids may reduce resistance to, and aid in, the establishment of bacterial, viral, or fungal infections and mask the clinical signs of an infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to substances in the product.
Cetraxal Plus may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate (see Adverse Reactions).
Effects on the ability to drive and use machines: Cetraxal Plus has no influence on the ability to drive and use machines due to the route of administration and the conditions of use.
Use in Children: Safety and efficacy of Cetraxal Plus have not been established in children younger than 6 months. Under exceptional circumstances, Cetraxal Plus treatment could be used in this sub-paediatric population after a very careful benefit/risk evaluation by prescribing physician taking into account that although there are no known safety concerns or differences in disease process to preclude use in these children, clinical experience is insufficient in these specific subgroups of paediatric population.