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Topical Fluoroquinolone Antibiotic Pregnancy: Can be used during pregnancy and during breast-feeding - systemic exposure to ciprofloxacin after otic administration is negligible, so no effects are anticipated (UK SPC 4.6).

Ciprofloxacin Ear Drops

Brand names: Cetraxal, Ciloxan Otic

Ciprofloxacin ear drops are a topical fluoroquinolone antibiotic preparation used for bacterial ear infections, including otitis externa and infection through grommets or perforations.

Adult dose

Dose: Acute otitis externa (auricular use): instil the contents of one single-dose ampoule of ciprofloxacin 2 mg/ml ear drops into the affected ear, twice daily for seven days
Route: Topical otic (auricular use only). Warm the ampoule by holding it in the hand for several minutes to avoid the dizziness that may result from instilling a cold solution into the ear canal. The patient should lie with the affected ear upward, the drops are instilled, the auricle is pulled several times, and the position maintained for around 5 minutes to facilitate penetration; repeat for the opposite ear if necessary. Not for ophthalmic use, inhalation or injection
Frequency: Twice daily for seven days
The SPC gives one regimen only, for adults and children aged one year and older. If an otowick/tampon is used to facilitate administration, the first dose should be doubled (2 ampoules instead of 1). The single-dose container should be discarded after use and not kept for subsequent use. Renal/hepatic impairment: no dosage adjustment is deemed necessary, since the drug plasma concentration is anticipated to be undetectable. Safety and efficacy have not been studied in the presence of a perforated tympanic membrane, so use with caution in patients with known or suspected perforation or where there is a risk of perforation. It is recommended not to use other ear preparations concomitantly. The mg content per ampoule is not stated in the retrieved SPC text, so only the 2 mg/ml strength from the product name is given here.

Paediatric dose

Dose: Children aged one year and older: contents of one single-dose ampoule into the affected ear - the same regimen as adults
Route: Topical otic (auricular)
Frequency: Twice daily for seven days
The SPC states: 'The safety and efficacy of Cetraxal in children aged below 1 year of age have not been established. No data are available.' Section 4.4 adds that although very limited data are available in patients less than 1 year of age treated for acute otitis externa, the prescribing physician should weigh the clinical benefits of use against the known and possibly unknown risks when prescribing below 1 year. This is not a weight-based product - the SPC gives no mg/kg figure, so no per-kilogram value is stored. Verify any use below 1 year against a children's formulary.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to ciprofloxacin, to any member of the quinolone class of antimicrobial agents, or to any of the excipients

Side effects

  • Ear pruritus (uncommon) - the most commonly reported reaction, in 0.9% of treated patients
  • Tinnitus (uncommon)
  • Headache (uncommon)
  • Dizziness (uncommon)
  • Dermatitis (uncommon)
  • Application site pain (uncommon)
  • Very rarely with locally applied fluoroquinolones: generalised rash, toxic epidermolysis, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria

Monitoring

  • Meticulous medical monitoring is required in otic use, so that the possible need for other therapeutic measures is identified in a timely manner
  • Reassess the disease and the treatment if some signs and symptoms persist after one week of therapy
  • Discontinue at the first appearance of a skin rash or any other sign of hypersensitivity - serious and occasionally fatal anaphylactic reactions, some after the first dose, have been reported with systemic quinolones
  • Watch for overgrowth of non-susceptible organisms including bacterial strains, yeast and fungi; initiate appropriate therapy if superinfection occurs

Clinical monograph

How it works

Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, blocking DNA replication and producing a bactericidal effect against a broad range of organisms.

Prescribing in practice

  • A topical preparation specifically licensed for aural use should be chosen, as some ciprofloxacin formulations are not intended for the ear.
  • It is particularly useful where Pseudomonas is a likely pathogen in otitis externa.
  • Aural toilet to remove debris improves antibiotic contact in the ear canal.

Monitoring

Review the ear clinically for response and tolerability during treatment.

Counselling the patient

  • Use only in the affected ear as directed.
  • Warming the bottle in the hand before use can reduce dizziness from cold drops.
  • Return if symptoms persist or worsen.

Evidence & guidelines

Topical quinolone ear drops are an established option for otitis externa and discharging ears in UK clinical guidance.

Reference: NICE NG91 Otitis Externa; SIGN Otitis Media Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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