Dermovate should be used with caution in patients with a history of local hypersensitivity to other corticosteroids or to any of the excipients in the preparation.
Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids.
If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see Adverse Reactions).
Dermovate Ointment contains propylene glycol which may cause skin irritation.
Dermovate Cream contains: propylene glycol which may cause skin irritation, cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis), chlorocresol which may cause allergic reactions.
Risk factors for increased systemic effects are: Potency and formulation of topical steroid; duration of exposure; application to a large surface area; use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings in infants the nappy may act as an occlusive dressing); increasing hydration of the stratum corneum; use on thin skin areas such as the face; use on broken skin or other conditions where the skin barrier may be impaired.
In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Infection risk with occlusion: Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in Psoriasis: Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.
Concomitant infection: Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
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.
Application to the face: Application to the face is undesirable as this area is more susceptible to atrophic changes. If used on the face, treatment should be limited to only 5 days.
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 from repeated exposure. If Dermovate does enter the eye, the affected eye should be bathed in copious amounts of water.
Effects on ability to drive and use machines: There have been no studies to investigate the effect of clobetasol on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical clobetasol.
Use in Children: In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Children are more susceptible to develop atrophic changes with the use of topical corticosteroids.
Duration of treatment for children and infants: Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be used.