Topical otic antibiotic + corticosteroid Pregnancy: No animal reproduction studies and no adequate or well-controlled studies in pregnant women have been conducted with the combination of ciprofloxacin and dexamethasone; this medicine should not be used during pregnancy unless clearly necessary and only if the potential benefit justifies the potential risk to the foetus. Breast-feeding: ciprofloxacin and corticosteroids appear in milk after oral administration and a risk to the suckling child cannot be excluded, so caution should be exercised during lactation.

Ciprofloxacin with dexamethasone

Brand names: Cetraxal Plus, Ciloxan-Dexa

This is a combined ear-drop suspension of the fluoroquinolone ciprofloxacin with the corticosteroid dexamethasone, used to treat acute otitis media in children with tympanostomy (grommet) tubes and acute otitis externa.

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: Four drops of ciprofloxacin 3 mg/ml + dexamethasone 1 mg/ml ear drops, suspension, instilled into the affected ear(s)

Route: Otic (ear drops) — for otic use only; not for ophthalmic use, inhalation or injection

Frequency: Twice a day for 7 days

UK SPC (Ciprofloxacin/dexamethasone 3 mg/ml + 1 mg/ml ear drops, suspension), adults and the elderly, for acute otitis externa, following the instillation instructions for patients with acute otitis externa. No overall differences in safety and effectiveness have been observed between elderly and other adult patients. PAEDIATRIC: this medicine has been shown to be safe and effective in paediatric patients 1 year of age and older for the treatment of acute otitis externa and can be used at the SAME DOSE AS IN ADULTS (no per-kilogram dose exists for this product, so the structured paediatric field is null). Safety and efficacy have not been established in children younger than 1 year in acute otitis externa; under exceptional circumstances it could be used in that age group after a very careful benefit-risk evaluation by the prescribing physician. METHOD: shake the bottle well before use; warm the suspension by holding the bottle in the hand for several minutes to avoid dizziness from a cold suspension; the patient should lie with the affected ear upward and the drops instilled while pulling several times on the auricle, maintaining the position for around 5 minutes to help the drops penetrate; repeat for the opposite ear if necessary. Do not touch the auricle, external ear canal, surrounding areas or other surfaces with the dropper tip; keep the bottle tightly closed when not in use and keep it until the treatment is complete. If otorrhoea persists after a full course, or two or more episodes occur within six months, further evaluation is recommended to exclude cholesteatoma, foreign body or tumour; if signs and symptoms persist after one week of therapy, reassess the disease and the treatment. NOTE ON SOURCES: the US label bundled with this record is ciprofloxacin 0.3% OPHTHALMIC solution (a different product, different route and different indications) and was not used for any field in this draft.

Dose adjustments

Renal

No dose adjustment is necessary in renal (or hepatic) impairment. Mild to moderate hepatic or renal impairment does not alter the pharmacokinetics of ciprofloxacin or dexamethasone after systemic administration; after topical otic administration small increases in plasma concentrations may occur in severe renal or hepatic impairment, but systemic exposure remains well below the plasma concentrations tolerated after recommended oral or intravenous doses.

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 ciprofloxacin, to other quinolones, to dexamethasone or to any of the excipients
Viral otic infections (e.g. varicella, herpes simplex)
Fungal otic infections

Side effects

Ear pain (common) — with ear pain and ear discomfort the most common reactions overall, occurring in approximately 1% to 1.5% of patients
Ear pruritus (the most frequently reported reaction in acute otitis externa, 1.5%), otorrhoea, ear congestion, ear discomfort and fungal ear infection (uncommon)
Paraesthesia (tingling in the ears) and crying (uncommon); dizziness and headache (rare); hypoacusis, tinnitus and medication residue present (rare)
Candidiasis (uncommon); flushing, vomiting, dysgeusia, skin exfoliation, tympanostomy tube obstruction, irritability and fatigue (uncommon)
Vision blurred and hypersensitivity (frequency not known) — serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with systemic quinolones, and tendon inflammation/rupture has been reported with systemic fluoroquinolones

Clinical monograph

How it works

Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV to kill common ear pathogens, while dexamethasone suppresses local inflammation, oedema and discharge.

Prescribing in practice

It is for auricular (ear) use only and must not be injected or used in the eye, and the suspension should be warmed in the hand before instillation to avoid dizziness.
The corticosteroid component means courses are kept short to limit the risk of secondary fungal or bacterial superinfection.
Treatment may be reconsidered if discharge persists or recurs, as this can indicate an unresponsive or resistant organism.

Monitoring

Review clinically for resolution of discharge and for any signs of superinfection rather than by laboratory tests.

Counselling the patient

Warm the bottle in your hands and lie with the treated ear uppermost for a few minutes after instilling the drops.
Tell the prescriber if the discharge does not settle or comes back.

Evidence & guidelines

Topical fluoroquinolone–corticosteroid ear drops are established therapy for otorrhoea associated with grommets and for otitis externa per their SPCs and ENT guidance.

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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