dexamethasone sodium metasulfobenzoate + framycetin sulfate + gramicidin: clinical use

Prescribing considerations

• Establish the diagnosis before ocular use; topical corticosteroids must not be used for an undiagnosed red eye.
• Exclude fungal, viral and untreated purulent infection before prescribing.
• Confirm tympanic-membrane integrity before auricular use.
• Stop treatment if sensitisation develops or reassess if clinical improvement is absent.
• Consider ototoxicity risk in infants, damaged tissue, renal or hepatic impairment, mitochondrial disease, or a maternal family history of deafness.

Contraindications and cautions

• Hypersensitivity to an active substance or excipient.
• Viral or fungal infection of the eye or ear, or untreated purulent infection.
• Ocular tuberculosis, glaucoma, herpes simplex keratitis or other viral corneal or conjunctival disease.
• Perforated eardrum.

Monitoring

• Review unexplained blurred vision or other visual disturbance and consider ophthalmology assessment.
• Repeated or prolonged ocular exposure requires review for raised intraocular pressure, cataract and masked infection.
• Monitor for systemic corticosteroid effects with strong CYP3A inhibitors.
• Remain alert to tinnitus, imbalance or hearing deterioration in patients at increased ototoxicity risk.

Clinical pharmacology

Dexamethasone is a synthetic glucocorticoid. Framycetin is an aminoglycoside active against susceptible Gram-negative organisms and Staphylococcus aureus; gramicidin is a cyclic polypeptide antimicrobial with mainly Gram-positive activity. Absorbed framycetin is renally excreted in active form.

Formulation and product differences

• A sterile, clear, colourless aqueous solution is authorised for ocular and auricular administration.
• It may be supplied in glass or plastic dropper bottles; available pack sizes may vary.