FOR UK HEALTHCARE PROFESSIONALS

For more information about Cetraxal®, please see the prescribing information.

Drehobl et al (2008)1

Non-inferiority study comparing the efficacy and safety of ciprofloxacin otic solution 0.2% to polymyxin B-neomycin-hydrocortisone (PNH) otic solution in the treatment of acute diffuse otitis externa in children, adolescents and adults. 630 patients were randomised to 7 days treatment with either Cetraxal solution 0.25ml twice-daily or PNH three times daily.

✓ Ciprofloxacin was found to be non-inferior to PNH (polymyxin-b-neomycin-hydrocortisone).
✓ Ciprofloxacin was well tolerated with only mild adverse events recorded: ear pruritus (0.9%), headache (0.6%) and application site pain (0.6%).

Cetraxal showed non-inferior efficacy to neomycin-based treatment, PNH

Lorente et al (2014)2

Randomised, double-blind, parallel-group clinical trial comparing the efficacy of ciprofloxacin otic solution 0.3% (4-6 drops every 8 hours for 8 days) with ciprofloxacin 0.3% and fluocinolone acetonide 0.025% otic solution (4-6 drops every 8 hours for 8 days)† in the treatment of diffuse otitis externa.

✓ Significantly greater reduction in intensity of oedema and otorrhoea in patients receiving ciprofloxacin + fluocinolone vs ciprofloxacin alone.
✓ Comparable resolution of otalgia between ciprofloxacin and ciprofloxacin + fluocinolone.
✓ Both treatments were well tolerated.

Use of steroid may be reserved for more complicated cases of AOE with swelling or known tympanic membrane perforation.

When AOE strikes, deploy Cetraxal

*Clinical cure was defined as absence of ear pain, swelling and discharge in patients who previously had these symptoms moderately or severely.
† Cetraxal Plus is licensed for use as one ampoule twice daily for seven days
† † Reduction of otalgia, oedema and otorrhoea based on visual analogue scale (VAS) score ranging from 0-10. A VAS score of 7-10 was classed as severe (or 3), 3.5-7 was classed as moderate (or 2), 0-3.5 was classed as mild (or 1) and 0 was classed as absent (or 0). The total symptom score was the sum of these three scores, ranging from 0-9
1. Drehobl, M. et al. (2008) Comparison of efficacy and safety of ciprofloxacin otic solution 0.2% versus polymyxin B-neomycin-hydrocortisone in the treatment of acute diffuse otitis externa.Current Medical 24,(12): pp. 3531-3542.
2. Lorente, J et. al; Ciprofloxacin plus fluocinolone acetonide versus ciprofloxacin alone in the treatment of diffuse otitis externa. The Journal of Laryngology & Otology (2014), 128, 591-598.
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Adverse events should be reported. Reporting forms and information can be found at:

Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148.www.mhra.gov.uk/yellowcard

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