Corticosteroid + aminoglycoside + polypeptide antibiotic Pregnancy: Inadequate evidence of safety in human pregnancy — use only if potential benefits to the mother outweigh the potential risks, including to the fetus. Topical corticosteroids in pregnant animals can cause fetal abnormalities (cleft palate, intrauterine growth retardation); there is a risk of foetal ototoxicity if aminoglycoside preparations are given in pregnancy. Use during breast-feeding only if benefits outweigh risks.

Dexamethasone with framycetin sulfate and gramicidin

Brand names: Sofradex

Used in: Meningitis & Encephalitis

This combination of dexamethasone, framycetin sulfate and gramicidin is a topical corticosteroid-antibacterial preparation applied as ear or eye drops for inflammatory conditions of the outer ear or eye with associated or suspected bacterial infection, such as 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: In the ear: two or three drops instilled into the ear three or four times daily. In the eye: one or two drops applied to each affected eye up to six times daily, or more frequently if required

Route: Auricular and ocular use (Sofradex Ear/Eye Drops, solution)

Frequency: Ear: three or four times daily. Eye: up to six times daily (or more frequently if required)

The SPC gives the same posology for adults (including elderly) and the paediatric population — no per-kg dose is stated. Treatment duration should be short and should not exceed 7 days (§4.2/§4.4). Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of clinical improvement, since prolonged use may lead to occult extension of infection, skin sensitisation and emergence of resistant organisms. Discontinue if there are signs of sensitivity to any ingredient. Aminoglycoside ototoxicity: framycetin may cause irreversible partial or total deafness when given systemically or applied topically to open wounds or damaged skin; the effect is dose-related and enhanced by renal or hepatic impairment — consider this when high-dose topical treatment is given to small children or infants. Increased ototoxicity risk in patients with mitochondrial mutations, particularly m.1555A>G. Paediatric: although infants are unlikely to be treated for prolonged periods, there is a risk of adrenal suppression after prolonged treatment with topical steroids.

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 or to any of the excipients
Viral or fungal infections of the eye and ear
Untreated purulent infections of the eye and ear (may be masked or enhanced by the steroid)
Use in the ear: eardrum perforation, because of the risk of ototoxicity
Use in the eye: tuberculosis; glaucoma; herpes simplex and other viral diseases of the cornea and conjunctiva, including where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility

Side effects

Hypersensitivity reactions, usually of the delayed type, leading to irritation, burning, stinging, itching and dermatitis (frequency not known)
Blurred vision (frequency not known)
Glaucoma / increased intraocular pressure, which may lead to optic nerve damage, reduced visual acuity and visual field defects
Posterior subcapsular cataract formation with intensive or prolonged topical corticosteroid use
Thinning of the globe leading to perforation in diseases causing thinning of the cornea or sclera

Interactions

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic corticosteroid side-effects — the combination should be avoided unless the benefit outweighs the increased risk (§4.5)

Clinical monograph

How it works

Dexamethasone provides local anti-inflammatory action while framycetin (an aminoglycoside) and gramicidin provide antibacterial cover against common susceptible organisms at the site of application.

Prescribing in practice

Because the framycetin component is potentially ototoxic, aural use should generally be avoided when the tympanic membrane is perforated, as access to the middle ear risks ototoxic cochlear damage.
Treatment should be short-term; prolonged use risks local antibiotic resistance, fungal superinfection and, with ocular use, corticosteroid-related rises in intraocular pressure.
It is contraindicated where the eye or ear infection is viral or fungal, as the steroid component may worsen these.

Monitoring

Review response over a short course and reassess if symptoms persist; with ocular use consider intraocular pressure on prolonged treatment.

Counselling the patient

Use only for the short course prescribed and do not continue long-term.
Tell the prescriber if you have a known hole in the eardrum or previous ear surgery.
Seek review if symptoms do not improve within a few days.

Evidence & guidelines

Combined topical corticosteroid-aminoglycoside ear and eye preparations are established treatments for infected inflammatory otitis externa and selected ocular conditions, with avoidance advised where the eardrum is perforated.

Reference: NICE CKS Otitis externa; ENT UK; 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.

Calculators

Pathways