Cetraxal Ear drops solution

/ CTS

Adults
Acute otitis externa and acute otitis media with tympanostomy tubes:
Instil 6-8 drops into the affected external ear canal every 12 hours for 7 days.
Paediatric population
The dosage in children aged 6 months and older is the same as for adults for both indications.
Method of administration
Auricular use.
Precautions to be taken before handling or administering the medicinal product.
The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled pulling several times on the auricle. This position should be maintained for around 1 minute to facilitate penetration of the drops into the ear.
Repeat, if necessary, for the opposite ear.
To prevent contamination of the dropper tip in order to limit bacterial risks, care should be taken not to touch the auricle or the external ear canal and surrounding areas, or 2 other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. Keep the bottle until the completion of the treatment.

Use in adults and in children aged 6 months and older for the following infections: – Acute otitis externa (AOE) – Acute otitis media in patients with tympanostomy tubes (AOMT) caused by ciprofloxacin susceptible microorganisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents

* Hypersensitivity to the active substances ciprofloxacin or fluocinolone acetonide or any member of the quinolones class of antimicrobial agents or to any of the excipients.
* Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

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 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 may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. See prescribing information for full details.

Ear Pain, ear discomfort, ear pruritus, dysgeusia. See prescribing information for full details.

No interaction studies have been performed with Cetraxal. However, due to negligible plasma levels observed after application in the ear (see section 5.2), it is unlikely that ciprofloxacin or fluocinolone acetonide may show clinically meaningful systemic interaction with other drugs.
The systemic administration of some quinolones has been shown to enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Oral administration of ciprofloxacin has been shown to inhibit cytochrome P450 CYP1A2 and CYP3A4 isozymes, and alter the metabolism of methylxanthine compounds (caffeine, theophylline). Following topical otic administration of Cetraxal, ciprofloxacin plasma concentrations are low, and it is unlikely that an interaction involving P450 metabolism with concomitant medications would result in clinically relevant changes in plasma levels of methylxanthine compounds.
It is recommended not to use other ear preparations concomitantly. If more than one medicine needs to be administered by this route, it is advised to administer them apart. See prescribing information for full details.

Pregnancy:
Data available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity. Since systemic exposure to ciprofloxacin will be very low no effects are anticipated on the foetus.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide. See prescribing information for full details.
Lactation:
Ciprofloxacin is excreted in breast milk. Since systemic exposure ciprofloxacin will be very low no effects are anticipated on the children that are breastfeeding.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. See prescribing information for full details.

No case of overdose has been reported.
Due to negligible plasma levels observed after application in the ear, it is unlikely that topically applied ciprofloxacin or fluocinolone acetonide may show clinically meaningful systemic effects. See prescribing information for full details.

Storage: Store below 30ºC