ARISTOCORT

What it is

ARISTOCORT ointment contains triamcinolone acetonide 1 mg (0.1%), neomycin (as sulfate) 2.5 mg, gramicidin 0.25 mg and nystatin 100,000 IU per gram. Triamcinolone acetonide is a topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive actions. Neomycin and gramicidin provide antibacterial activity against microorganisms likely to be responsible for topical bacterial infections. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.

Approved indications

— Relief of the inflammatory and pruritic manifestations of dermatoses likely to become or which are already infected.

Dosing overview

Apply to the affected area 2 to 3 times daily.

Key safety warnings

Because of the potential hazard of nephrotoxicity and ototoxicity, this medication should not be used in patients with extensive skin damage or other conditions where absorption of neomycin is possible. The use of occlusive dressing should be avoided because of the increased risk of sensitivity reactions and increased percutaneous absorption particularly of triamcinolone acetonide and neomycin. Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi other than Candida, and corticosteroids can enhance microbial infections, so constant observation of the patient is essential. If a favourable response does not occur promptly, application should be discontinued until the infection is adequately controlled by other anti-infective measures. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycaemia and glucosuria in some patients, with conditions which augment systemic absorption including the application of the more potent steroids, use over large surface areas and prolonged use. Use of this medication over large surface areas or for prolonged periods in paediatric patients could result in sufficient systemic absorption to produce systemic effects, and paediatric patients may demonstrate greater susceptibility to HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Visual disturbance may be reported 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 (CSCR).

Contraindications

Known hypersensitivity to triamcinolone, neomycin, nystatin or gramicidin. Ophthalmic use. Tuberculous lesions and most viral lesions of the skin such as Herpes simplex, but particularly in vaccinia and varicella.

Regulatory history

ARISTOCORT 0.02% ointment (triamcinolone acetonide 0.2 mg/g) was first listed on the ARTG on 9 September 1991.