⚠️ Warnings
If irritation develops during the use of Elocom, treatment must be discontinued and appropriate therapy initiated.
If a skin infection develops, appropriate antifungal or antibacterial treatment should be started.
If the infection does not respond promptly to such treatment, the use of Elocom must be discontinued until the infection is adequately controlled.
Systemic absorption of topical corticosteroids can cause reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which may potentially lead to glucocorticoid insufficiency after treatment is stopped. In some patients, systemic absorption of topical corticosteroids may manifest during treatment as Cushing's syndrome, hyperglycaemia or glycosuria. Patients applying topical corticosteroids to a large body surface area and/or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression.
Local and systemic toxicity is common, particularly following prolonged use on large areas of damaged skin, in flexures and with polythene occlusive dressings. Occlusion should not be used in children or on the face. If used on the face, the duration should be limited to 5 days. Continuous long-term therapy should be avoided in all patients regardless of age.
The use of topical corticosteroids in psoriasis is hazardous for a number of reasons, including the possibility of increased relapse due to the development of tolerance, the risk of generalised pustular psoriasis and the development of local or systemic toxicity owing to impairment of the barrier function of the skin. If Elocom is used in patients with psoriasis, careful monitoring of these patients is important.
As with all potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. When topical treatment with potent corticosteroids is discontinued, a rebound phenomenon may occur in the form of dermatitis with intense skin redness, stinging and burning. This can be prevented by gradually reducing treatment, for example by continuing treatment intermittently before stopping it.
Any of the adverse reactions reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Corticosteroids may alter the appearance of some lesions, making correct diagnosis more difficult, and may also delay healing.
Topical Elocom preparations are not intended for ophthalmic use, including on the eyelids, because of the very rare risk of developing glaucoma or subcapsular cataract.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after systemic and topical corticosteroid use.
Paediatric population
Elocom may be used with caution in paediatric patients over 2 years of age, although the safety and efficacy of use for longer than 3 weeks have not been established. As the safety and efficacy of Elocom in paediatric patients under 2 years of age have not been established, use in this age group is not recommended.
Because of their greater skin surface area to body weight ratio, paediatric patients may be more susceptible to systemic toxicity than adults at equivalent doses.
