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Topical Antibiotic-Steroid — Otitis Externa Pregnancy: Topical use — use with caution; avoid prolonged courses; safe for short-term acute otitis externa

Framycetin / Sofradex

Brand names: Sofradex (framycetin + dexamethasone + gramicidin)

Adult dose

Dose: 2–3 drops
Route: Otic
Frequency: Three to four times daily for up to 7 days
Max: 3 drops per ear four times daily
Combination topical preparation: framycetin (aminoglycoside antibacterial) + gramicidin (antibacterial) + dexamethasone 0.1% (anti-inflammatory). Used for acute otitis externa with significant inflammation. CONTRAINDICATED with perforated tympanic membrane — aminoglycoside ototoxicity. Also licensed as eye drops for conjunctivitis.

Paediatric dose

Dose: 2–3 drops drops/kg
Route: Otic
Frequency: Three times daily
Max: 3 drops per ear three times daily
BNFc: avoid prolonged use in children; CONTRAINDICATED with perforated TM. Review after 7 days.

Dose adjustments

Renal

No dose adjustment required (topical)

Hepatic

No dose adjustment required

Paediatric weight-based calculator

BNFc: avoid prolonged use in children; CONTRAINDICATED with perforated TM. Review after 7 days.

Clinical pearls

  • Framycetin is an aminoglycoside antibiotic — same ototoxicity risk as neomycin and gentamicin with perforated TM; NEVER use with perforation
  • Sofradex is dual-purpose (ear and eye) — same formulation used for otitis externa and bacterial conjunctivitis; verify indication before prescribing
  • Contact sensitisation: framycetin cross-reacts with neomycin — patients sensitised to neomycin (Otosporin) will also react to Sofradex
  • Dexamethasone component reduces canal oedema, which is often as important as treating infection in OE
  • Duration: limit to 7 days — prolonged aminoglycoside use increases sensitisation and risk; review and switch to alternative if extending course
  • If TM status uncertain: use acetic acid drops (EarCalm) or ciprofloxacin ear drops (Ciloxan) — safe with perforation

Contraindications

  • Perforated tympanic membrane — CONTRAINDICATED (framycetin is aminoglycoside — ototoxic)
  • Fungal or viral otitis externa
  • Hypersensitivity to framycetin or neomycin (cross-reactivity)

Side effects

  • Aminoglycoside ototoxicity (with perforated TM)
  • Contact sensitisation to framycetin (neomycin cross-reactive)
  • Local irritation
  • Adrenal suppression (prolonged use — dexamethasone component)

Interactions

  • Negligible at topical otic doses

Monitoring

  • Symptom response at 7 days
  • TM integrity before prescribing
  • Signs of sensitisation

Reference: BNFc; BNF 90; BNFc; ENT-UK Otitis Externa Guidelines; NICE CKS Otitis Externa. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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