Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see sections 4.8 and 4.9).
Application to the Face
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema with this medicinal product.
Application to the Eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result.
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, 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) which have been reported after use of systemic and topical corticosteroids.
Chronic leg ulcers
Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Paediatric population
In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.
Use in Psoriasis
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.
Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
Infection
If infection persists, systemic chemotherapy is required. Any spread of infection requires withdrawal of topical corticosteroid therapy. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
Do not continue for more than 7 days in the absence of clinical improvement, since occult extension of infection may occur due to the masking effect of the steroid.
Staining
This medicinal product may stain hair, skin or fabric, and the application should be covered with a dressing to protect clothing.
Dilution
Products which contain antimicrobial agents should not be diluted.
The least potent corticosteroid which will control the disease should be selected.
Neurotoxicity
There is a theoretical risk of neurotoxicity from the topical application of clioquinol, particularly when Betamethasone/Clioquinol skin preparations are used for prolonged periods or under occlusion.
Fire hazard in contact with dressings, clothing and bedding
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
These preparations do not contain lanolin or parabens.