CETRAXAL EAR DROPS SOLUTION 2MG/ML

4.1 Therapeutic indications

Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa caused by ciprofloxacin susceptible microorganisms (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.3 Contraindications

Hypersensitivity to the active substance ciprofloxacin or any member of the quinolone class of antimicrobial agents or to any of the excipients.

4.2 Posology and method of administration

Adults and children aged one year and older:

Instill the contents of one single ampoule into the affected ear twice daily for seven days.

Paediatric patients less than one year

The safety and efficacy of Cetraxal in children aged below 1 year of age have not been established. No data are available. See section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Instructions for correct use of the product:

• The solution should be warmed, by holding the ampoule in the hand for several minutes, to avoid the dizziness 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 5 minutes to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
• The patient should be advised to discard the single-dose container after the use, and not keep it for subsequent use.
• In case an otowick/tampon is used to facilitate administration, the first dose should be doubled (2 ampoules instead of 1).

Renal/ hepatic impairment

Since the drug plasma concentration is anticipated to be undetectable, no dosage adjustment for these patient groups is deemed necessary.