Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
Avekort Furoate 1mg/g Cream is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster, chickenpox, verrucae vulgares, condylomata acuminate and molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Avekort Furoate 1mg/g Cream should not be used on wounds or on skin which is ulcerated.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
| Table 1: Treatment-related adverse reactions reported with Avekort Furoate by body system and frequency Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated from available data) | |
| Infections and infestations Not known Very rare Nervous system disorders Not known Very rare Eye disorders Not known Skin and subcutaneous tissue disorders Not known Very rare General disorders and administration site conditions Not known |
Infection, furuncle Folliculitis
Paraesthesia, Burning sensation )
Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy Pruritus Application site pain, application site reactions |
Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and development of children.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
There are no findings of relevance to the prescriber other than those mentioned elsewhere in the SPC.
Avekort Furoate 1mg/g Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.
This medicinal product is indicated in adults and children above 6 years of age.
Avekort furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.
In the croton oil assay in mice, Avekort was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.
In guinea pigs, Avekort was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.
Pharmacokinetic studies have indicated that systemic absorption following topical application of Avekort furoate cream 1mg/g is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.
If irritation or sensitisation develop with the use of Avekort Furoate 1mg/g Cream, treatment should be withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of Avekort Furoate in paediatric patients below 6 years of age have not been established, its use in this age group is not recommended.
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.
Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised 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.
As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.
Avekort Furoate 1mg/g Cream contains propylene glycol which may cause skin irritation. Avekort Furoate 1mg/g Cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Avekort Furoate 1mg/g Cream topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex 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, 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.
None stated.
Posology
Adults, including elderly patients, adolescents and children aged 6 years and over: A thin film of Avekort Furoate 1mg/g Cream should be applied to the affected areas of skin once daily. One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand.
Use of a weaker corticosteroid is often advisable when there is a clinical improvement.
Paediatric population
Avekort Furoate 1mg/g Cream should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children a maximum of 10% of body surface area should be treated.
Use of topical corticosteroids in children aged 6 years and over, or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.
Children below 6 years: Avekort Furoate 1mg/g Cream is not recommended for use in children below 6 years of age due to insufficient data on safety.
Not applicable.
