Topical otic antibiotic + corticosteroid Pregnancy: eMC §4.6: data on ciprofloxacin in pregnant women indicate no malformative or foeto/neonatal toxicity and, as systemic exposure after ear administration is very low, no effects on the foetus are anticipated. Corticosteroids have been teratogenic in laboratory animals given systemically at relatively low doses and some are teratogenic after dermal application; there are no adequate and well-controlled studies of fluocinolone acetonide teratogenicity in pregnant women. Before administering, assess whether the benefits of treatment outweigh the possible risk. Breastfeeding: ciprofloxacin is excreted in breast milk but systemic exposure will be very low, so no effects on the breastfed child are anticipated; systemically administered corticosteroids appear in human milk and it is not known whether topical corticosteroid administration produces detectable quantities - caution should be exercised in a nursing woman. Fertility: no animal studies performed.

Ciprofloxacin with fluocinolone acetonide

Brand names: Cetraxal Plus, Otovel

This is a combined ear-drop solution of the fluoroquinolone ciprofloxacin with the corticosteroid fluocinolone acetonide, used for acute otitis externa and for otitis media with discharge in patients with tympanostomy tubes.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Instil the contents of one single-dose container into the affected ear canal every 12 hours for 7 days

Route: Auricular (ear drops). For auricular use only - not for ophthalmic use, inhalation or injection; must not be swallowed or injected (eMC §4.4)

Frequency: Every 12 hours for 7 days

eMC §4.2 (Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops solution - the fixed combination of ciprofloxacin and fluocinolone acetonide, so the source matches this page's product). The same regimen applies to both licensed indications: acute otitis externa, and acute otitis media with tympanostomy tubes. ELDERLY: no overall differences in safety and effectiveness have been observed between elderly and other adult patients. RENAL/HEPATIC IMPAIRMENT: no dosage adjustment is deemed necessary. PAEDIATRIC: the SPC states that the dosage in children aged 6 months and older is the same as for adults for both indications - this is not a per-kg dose, so no structured paediatric dose is given here. Safety and efficacy have not been established in children younger than 6 months; §4.4 says treatment could be used in that sub-group only under exceptional circumstances after a very careful benefit/risk evaluation by the prescribing physician. Verify any under-18 use against a children's formulary. ADMINISTRATION (§4.2): warm the solution before use by holding the bottle in the hand for several minutes to avoid discomfort from instilling a cold solution; the patient should lie with the affected ear upward; for otitis externa instil the drops while pulling several times on the auricle; for acute otitis media with tympanostomy tubes pump the tragus 4 times by pushing inward to facilitate penetration into the middle ear; maintain the position for around 1 minute; repeat for the opposite ear if necessary. PROVENANCE NOTE: the openFDA record in this bundle is for ciprofloxacin OPHTHALMIC solution 0.3% (single agent, eye route) and was NOT used for any dose here - it is a different product, route and indication.

Dose adjustments

Renal

eMC §4.2: no dosage adjustment is deemed necessary in renal or hepatic impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances ciprofloxacin or fluocinolone acetonide, to any member of the quinolone class of antimicrobial agents, or to any of the excipients (eMC §4.3)
Viral infections of the external ear canal, including varicella and herpes simplex infections (eMC §4.3)
Fungal otic infections (eMC §4.3)

Side effects

Dysgeusia (common)
Ear pain, ear discomfort, ear pruritus (common)
Paraesthesia (tingling in ears), dizziness, headache, crying (uncommon)
Hypoacusis, tinnitus, otorrhoea, ear congestion, tympanic membrane disorder, auricular swelling (uncommon)
Candidiasis, fungal ear infection, contralateral otitis media (uncommon); skin exfoliation, erythematous rash, rash, granulation tissue (uncommon); blurred vision (frequency not known - consider ophthalmology referral, see §4.4)

Interactions

eMC §4.5: no interaction studies have been performed with this product; because plasma levels after application in the ear are negligible, it is considered unlikely that ciprofloxacin or fluocinolone acetonide would show clinically meaningful systemic interactions (the §4.5 text is truncated in this bundle - clinician to confirm in the full SPC)
eMC §4.4 (class caution, not a formal interaction): the risk of tendon rupture reported with systemic fluoroquinolones may be increased in patients receiving corticosteroids, especially geriatric patients; to date clinical and post-marketing data have not demonstrated a clear association between otic ciprofloxacin and these reactions

Clinical monograph

How it works

Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV to provide antibacterial cover, while fluocinolone acetonide reduces local inflammation and pruritus.

Prescribing in practice

It is for auricular use only and must not be used in the eye, and the drops should be warmed in the hand before instillation to reduce vestibular upset.
Treatment is short term because prolonged topical corticosteroid use can favour fungal or resistant bacterial superinfection.
Persistent or recurrent discharge should prompt clinical reassessment and consideration of an alternative agent.

Monitoring

Monitor by clinical response, watching for resolution of discharge and any emergent superinfection.

Counselling the patient

Warm the bottle in your hands and keep the treated ear uppermost briefly after each dose.
Report itching, worsening discharge or a lack of improvement to your prescriber.

Evidence & guidelines

Combined ciprofloxacin–corticosteroid ear preparations are supported for ear infection by their SPCs and standard ENT prescribing practice.

Reference: 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).

Curated clinical cross-links plus same-class fallbacks.

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