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Ciprofloxacin and fluocinolone acetonide auricular

Updated 2 Feb 2023 | Anti-infective preparations


Ear drops containing ciprofloxacin and fluocinolone acetonide.

Drugs List

  • CETRAXAL PLUS 3mg+0.25mg/ml ear drops 0.25ml unit dose
  • ciprofloxacin 3mg/ml and fluocinolone acetonide 0.25mg/ml ear drops preservative-free 0.25ml unit dose
  • Therapeutic Indications


    Acute otitis externa
    Acute otitis media in patients with tympanostomy tubes



    Instil the contents of 1 dose unit into the affected ear(s) every 12 hours for 7 days.


    Children over 6 months
    Instil the contents of 1 dose unit into the affected ear(s) every 12 hours for 7 days.

    Children under 6 months
    This medication may used under exceptional circumstances if the expected benefit to the child is greater than any risk.


    None known

    Precautions and Warnings

    Children under 6 months

    Exclude external ear canal viral infection before initiating treatment
    Exclude fungal ear infection before initiating treatment
    Evaluate for other conditions if otorrhea persists/reoccurs after treatment
    If visual disturbances occur, perform ophthalmic evaluation
    Hypersensitivity reactions may be masked by the presence of the steroid
    Prolonged use may result in superinfection with non-susceptible organisms
    Discontinue if drug-related rash or other hypersensitivity reactions occur

    Pregnancy and Lactation


    Use the combination of ciprofloxacin and fluocinolone acetonide with caution during pregnancy.

    The manufacturer notes that systemic exposure will be very low but consideration should be given to the expected benefit to the mother outweighing any risk to the foetus.

    No malformative or foetal/neonatal toxicity is indicated in human pregnancy.


    Use the combination of ciprofloxacin and fluocinolone acetonide with caution during breastfeeding.

    The manufacturer notes that ciprofloxacin is excreted in breast milk but systemic exposure to it will be very low.

    Side Effects

    Auricular swelling
    Blurred vision
    Ear congestion
    Ear discomfort
    Ear fungal infection
    Ear pain
    Ear pruritus
    Erythematous rash
    Hypertrophic granulation
    Medication residue
    Otitis externa
    Otitis media
    Skin exfoliation
    Tympanic membrane disorder
    Tympanostomy tube obstruction


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2018

    Reference Sources

    Summary of Product Characteristics: Cetraxal Plus 3mg/ml + 0.25mg/ml ear drops solution in single-dose container.. Aspire Pharma Limited. Revised May 2019.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.