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Topical Antibiotic-Steroid — Otitis Externa Pregnancy: UK SPC §4.6: 'There is inadequate evidence of safety in human pregnancy. Sofradex should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus. There is a risk of foetal ototoxicity if aminoglycoside antibiotics preparations are administrated during pregnancy.' Breast-feeding: 'The product should be used during breast-feeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child.'

Framycetin / Sofradex

Brand names: Sofradex (framycetin + dexamethasone + gramicidin)

Framycetin sulfate is an aminoglycoside antibiotic used topically in the ear, including in the compound preparation Sofradex which also contains the corticosteroid dexamethasone and the antibiotic gramicidin, for otitis externa.

Adult dose

Dose: Ear (this page's indication — infected inflammatory conditions of the outer ear / otitis externa): two or three drops instilled into the affected ear three or four times daily. Treatment duration should be short and must not exceed 7 days. SCOPE NOTE: the same SPC also licenses an ocular regimen (one or two drops to each affected eye up to six times daily) — that eye regimen is deliberately NOT reproduced on this otic page and must not be applied to the ear.
Route: Auricular (ear drops) — instilled into the affected ear. Sofradex is licensed for auricular and ocular use; this page covers the auricular route only
Frequency: Three or four times daily, for no more than 7 days
Verbatim source wording (UK SPC §4.2, Posology): 'Adults (including elderly) and paediatric population: In the Eye: One or two drops applied to each affected eye up to six times daily or more frequently if required. In the Ear: Two or three drops instilled into the ear three or four times daily.' Method of administration, verbatim: 'Auricular and Ocular use. Treatment duration should be short (not to exceed 7 days) (see section 4.4).' NO maxDose FIELD IS POPULATED: the SPC states no numeric dose ceiling for the ear, only the 7-day duration limit and the 'two or three drops, three or four times daily' range already given above — importing the ocular 'up to six times daily' figure as a ceiling would be a different route and is not done. COMBINATION PRODUCT: Sofradex contains an aminoglycoside (framycetin), a second antibiotic (gramicidin) and a corticosteroid (dexamethasone); the 7-day limit exists because 'prolonged use may lead to occult extension of infections due to the masking effect of the steroid' and to 'skin sensitisation and the emergence of resistant organisms' (§4.4). §4.4 was truncated at the source-fetch limit part-way into §4.5, so the interaction section is incomplete — the only interaction text retrieved is that co-treatment with CYP3A inhibitors including cobicistat-containing products is expected to increase the risk of systemic side-effects and the combination should be avoided unless the benefit outweighs the increased risk.

Paediatric dose

Route: Auricular (ear drops) — instilled into the affected ear
Frequency: Three or four times daily, for no more than 7 days
The SPC gives the SAME ear regimen for adults, the elderly and the paediatric population — 'Adults (including elderly) and paediatric population: ... In the Ear: Two or three drops instilled into the ear three or four times daily' (§4.2). dosePerKg IS DELIBERATELY NULL and concentration IS DELIBERATELY NULL: this is a topical drop instilled by count, not a weight-based or concentration-based dose, so no figure may drive a weight calculator. PAEDIATRIC CAUTIONS (§4.4): aminoglycosides 'may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin... the possibility should be considered when high dose topical is given to small children or infants'; and 'Although it is unlikely that infants will be treated with Sofradex for prolonged periods, there is a risk of adrenal suppression, even without occlusive dressings, after prolonged treatment of these patients with topical steroids.' Verify any under-18 use 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 the active substances or to any of the excipients listed in section 6.1 (§4.3)
  • EAR — eardrum perforation, because of the risk of ototoxicity (§4.3). This is the key contraindication for this page: exclude perforation before instilling
  • Viral or fungal infections of the eye and ear (§4.3)
  • Untreated purulent infections of the eye and ear, 'which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid' (§4.3)
  • Ocular use only (listed for completeness, not applicable to the auricular route): tuberculosis; glaucoma; herpes simplex and other viral diseases of the cornea and conjunctiva, including where herpetic keratitis such as dendritic ulcer is considered a possibility (§4.3)
  • Not a contraindication but an avoidance (§4.5, section truncated at the fetch limit): co-treatment with CYP3A inhibitors including cobicistat-containing products is expected to increase the risk of systemic side-effects and should be avoided unless the benefit outweighs the increased risk

Side effects

  • Immune system disorders, frequency not known (§4.8): 'Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis'
  • Ototoxicity — aminoglycoside antibiotics 'may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment' (§4.4)
  • Increased risk of ototoxicity in patients with mitochondrial mutations, particularly m.1555A>G, including where aminoglycoside serum levels were within the recommended range; some cases associated with a maternal history of deafness and/or mitochondrial mutation (§4.4)
  • Eye disorders, frequency not known (§4.8): blurred vision, glaucoma; topical steroid use may raise intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects; intensive or prolonged use may cause posterior subcapsular cataracts
  • Skin sensitisation and emergence of resistant organisms with prolonged use (§4.4)
  • Adrenal suppression after prolonged treatment of infants with topical steroids (§4.4)

Monitoring

  • Stop rule (§4.4): 'Treatment should be discontinued if there are signs of sensitivity to any of its ingredients.'
  • Duration rule (§4.4): 'Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.'
  • Exclude tympanic membrane perforation before instilling — perforation is an absolute contraindication because of ototoxicity risk (§4.3)
  • Corticosteroid course review (§4.4): 'Treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular, pressure, cataract formation or unsuspected infections.'
  • Visual disturbance (§4.4): if blurred vision or other visual disturbance is reported, consider referral to an ophthalmologist for possible cataract, glaucoma or central serous chorioretinopathy

Clinical monograph

How it works

Framycetin and gramicidin act as topical antibacterial agents against common ear pathogens, while the dexamethasone component in Sofradex reduces local inflammation and oedema.

Prescribing in practice

  • Avoid use when the tympanic membrane is perforated, as the aminoglycoside framycetin can cause ototoxicity if it reaches the middle ear.
  • Aminoglycosides such as framycetin can cause local hypersensitivity and contact sensitisation, so discontinue if local reactions develop.
  • Limit to short courses and review if symptoms persist to reduce sensitisation and the risk of fungal or resistant superinfection.

Monitoring

Monitor clinically for resolution and for any new hearing disturbance, tinnitus or local hypersensitivity during use.

Counselling the patient

  • Use only in the affected ear and for the short course advised.
  • Stop and seek advice if you notice dizziness, hearing changes, ringing in the ears or a rash.
  • Let the clinician know if your eardrum may be perforated.

Evidence & guidelines

Topical antibiotic-corticosteroid ear preparations are an established treatment for otitis externa, used cautiously in the presence of a perforated eardrum per UK ENT guidance.

Reference: ENT-UK Otitis Externa Guidelines; NICE CKS Otitis Externa; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. 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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