Fucicort Cream

/ Dexcel

A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. In the more resistant lesions the effect of Fucicort cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.

Treatment of eczematous dermatoses when secondary bacterial infection is confirmed.

Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the excipients.
Due to the content of corticosteroid, Fucicort is contraindicated in the following conditions:
Systemic fungal infections.
Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment.
Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy.
Perioral dermatitis and rosacea.

Long-term continuous topical therapy with Fucicort should be avoided.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucicort.
Due to the content of corticosteroid, Fucicort should be used with care near the eyes. Avoid getting Fucicort into the eyes.
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.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fucicort should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing’s syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment.
Due to the content of betamethasone valerate, prolonged topical use of Fucicort may cause skin atrophy.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance. This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, Fucicort may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment.
Fucicort cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions.
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.
Long term 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 advice is recommended in these cases or other treatment options should be considered.

The most frequently reported adverse reaction during treatment is pruritus.
Paediatric population: The observed safety profile is similar in children and adults.
See prescribing information for full details.

No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.

Pregnancy:
Fusidic acid: No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid.
Betamethasone valerate: There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities.
Fucicort should not be used during pregnancy unless clearly necessary.
Breast-feeding:
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the topically applied fusidic acid and betamethasone valerate to a limited area of skin of breast-feeding woman is negligible. Fucicort can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant.
See prescribing information for full details.

For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing’s syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than three weeks.
Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of Fucicort does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.