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ELIDEL is a brand name for Pimecrolimus. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of patients 3 months of age and older with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible. This may include: • Intolerance to topical corticosteroids • Lack of effect of topical corticosteroids • Use on the face and neck where prolonged…
Verbatim from this product's MHRA label. Tap a section to expand.
Elidel should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Elidel can be used in the short term for the treatment of the signs and symptoms of atopic eczema and intermittently in the long term for the prevention of progression to flares.
Elidel treatment should begin at the first appearance of signs and symptoms of atopic dermatitis. Elidel should only be applied to areas affected with atopic dermatitis. Pimecrolimus should be used for as short period as possible during flares of disease.
The patient or caregiver should stop using pimecrolimus when signs and symptoms resolve. Treatment should be intermittent, short-term and not continuous. If no improvement occurs after 6 weeks, or in case of disease exacerbation, treatment should be stopped.
The diagnosis of atopic dermatitis should be re- evaluated and further therapeutic options considered. Adults Apply a thin layer of Elidel to the affected skin twice daily and rub in gently and completely. Each affected region of the skin should be treated with pimecrolimus until clearance occurs and then treatment should be discontinued.
Elidel may be used on all skin areas, including the head and face, neck and intertriginous areas, except on mucous membranes. 4). In the long-term management of atopic dermatitis (eczema), Elidel treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease.
Elidel should be used twice daily. Emollients can be applied immediately after using Elidel. Paediatric population For infants (3-23 months), children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.
Elderly patients Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over. Clinical studies with Elidel did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.
Method of administration Elidel should be applied thinly to the affected areas twice daily.
The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with Elidel and 16% of patients in the control groups. These reactions generally occurred early in treatment, were mild/moderate and were of short duration.
The following undesirable effects have been observed with the frequencies indicated below during clinical trials using pimecrolimus cream 1% and from spontaneous reporting. Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: 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, including isolated reports).
g. 4). 4). Paediatric population The clinical safety database of children aged 3 months and older treated with pimecrolimus 1% cream is extensive with long-term safety data available for up to 5 years. The safety profiles in infants, children and adolescent were comparable in nature and frequency of the adverse events observed.
The most common observed adverse reactions were application site reactions. 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.
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Pimecrolimus cream should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression. Long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown.
Pimecrolimus should not be applied to potentially malignant or pre-malignant skin lesions. Pimecrolimus should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chicken pox). Elidel has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Before commencing treatment with Elidel, clinical infections at treatment sites should be cleared. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi's varicelliform eruption), treatment with pimecrolimus may be associated with an increased risk of skin herpes simplex virus infection, or eczema herpeticum (manifesting as rapid spread of vesicular and erosive lesions).
In the presence of herpes simplex skin infection, pimecrolimus treatment at the site of infection should be discontinued until the viral infection has cleared. Patients with severe atopic dermatitis may have an increased risk of skin bacterial infections (impetigo) during treatment with pimecrolimus.
8). If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated. Care should be taken to avoid contact with eyes and mucous membranes. If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed off with water.
5). Elidel contains the active substance pimecrolimus, a calcineurin inhibitor. In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
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8). However, patients with atopic dermatitis treated with Elidel have not been found to have significant systemic pimecrolimus levels. 8). These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy.
Of these 14 cases, the majority had either a clear aetiology or were known to resolve. Patients who receive Elidel 10mg/g cream and who develop lymphadenopathy should have the aetiology of their lymphadenopathy investigated. In the absence of a clear aetiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, treatment with pimecrolimus should be discontinued.
Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves. 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. Populations with potentially higher risk of systemic exposure. Elidel has not been studied in patients with Netherton’s syndrome. Due to the potential for increased systemic absorption of pimecrolimus, Elidel is not recommended in patients with Netherton's syndrome.
As the safety of pimecrolimus has not been established in erythrodermic patients, the use of Elidel in this patient population cannot be recommended. The use of Elidel under occlusion has not been studied in patients. Occlusive dressings are not recommended.
In patients with severely inflamed and/or damaged skin, the systemic concentrations may be higher. g. contact dermatitis). Further Elidel also contains 10 mg benzyl alcohol per 1 g cream, which may cause allergic reactions and mild local irritation.
Elidel also contains 50 mg propylene glycol (E 1520), per 1 g cream which may cause skin irritation.