SOFRAMYCIN

What it is

SOFRAMYCIN is a clear bright colourless aqueous solution containing framycetin sulfate 5 mg, gramicidin 50 μg and dexamethasone (as sodium metasulfobenzoate) 500 μg per mL. Framycetin sulfate is a bactericidal antibiotic active against a wide variety of Gram-positive and Gram-negative bacteria commonly found in superficial infections, including staphylococci, Pseudomonas aeruginosa, coliforms and pneumococci. Gramicidin reinforces the action of framycetin sulfate against streptococci. Dexamethasone is a highly potent topical corticosteroid.

Approved indications

— Inflammatory and allergic conditions of the ear, for example otitis externa.

Dosing overview

Two or three drops should be instilled into the ear three or four times daily; alternatively, a gauze wick kept saturated with the drops may be inserted into the external auditory meatus.

Key safety warnings

Treatment with corticosteroid/antibiotic combinations should not be continued in the absence of clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid, and may also lead to skin sensitisation and the emergence of resistant organisms. Aminoglycoside antibiotics may cause irreversible, partial or total deafness when applied topically to open wounds or damaged skin, and this effect is aggravated by renal or hepatic impairment and by prolonged duration of treatment. There have been reported cases of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, and although no cases were identified with topical preparations of neomycin, framycetin or gentamicin, the potential for a similar effect with neomycin and other aminoglycosides administered topically cannot be ruled out. Visual disturbance may be associated with systemic and topical corticosteroid use, and if a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy. Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids, and corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.

Contraindications

Contraindications include hypersensitivity to the active substances or to any of the excipients, viral and fungal infections, tubercular lesions, varicella, vaccinia, eardrum perforation, and acute purulent untreated infections.

PBS listing

SOFRAMYCIN eye or ear drops containing framycetin sulfate 5 mg per mL in 8 mL bottles are listed on the PBS with 2 items, unrestricted restriction, at an ex-manufacturer price of A$2.85.

Regulatory history

SOFRAMYCIN was first approved on 1 April 1993. The product was first listed on the ARTG on 7 January 1994 under licence category RE.