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  • Eumovate Ointment/Cream
    / GSK


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cream

    25 g

    full basket chart 811 5092

    Cream

    30 g

    full basket chart 25833

    Ointment

    25 g

    full basket chart 2530 5093

    Dosage

    Route of administration: Cutaneous
    Adults, Elderly, Children and Infants from the age of 3 month: Ointments are especially appropriate for dry, lichenified or scaly lesions. Creams are especially appropriate for moist or weeping surfaces.
    Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient.
    Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
    Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations.
    Duration of treatment for adults and elderly: Continuous daily treatment for longer than four weeks is not recommended. If the condition worsens or does not improve within four weeks, treatment and diagnosis should be re-evaluated.
    Paediatric population: Use in children under 12 years should be on the advice of a doctor. Care should be taken when using clobetasone to ensure the amount applied is the minimum that provides therapeutic benefit.
    Duration of treatment for children and Infants: When clobetasone is used in the treatment of dermatoses in children, extreme caution is required and treatment should not normally exceed 7 days.
    If the condition worsens or does not improve within 7 days, treatment should be reviewed.
    Once the condition has been controlled, the frequency of application should be reduced to the lowest effective dose for the shortest time possible.
    Continuous daily treatment for longer than four weeks is not recommended in
    children.
    Elderly: Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
    Renal / Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.


    Indications

    Cream: Topical treatment for corticosteroids responsive dermatosis.
    Ointment: Eumovate ointment is a moderately potent topical corticosteroid indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.
    These include the following:
    – Atopic dermatitis
    – Irritant or allergic contact dermatitis
    – Seborrhoeic dermatitis
    – Nappy rash
    – Photodermatitis
    – Otitis externa
    – Prurigo nodularis
    – Insect bite reactions
    Eumovate may be used as maintenance therapy between courses of one of the more potent topical steroids.


    Contra-Indications

    Untreated cutaneous infections; Rosacea; Acne vulgaris; Pruritus without inflammation; Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Eumovate should be used with caution in patients with a history of local hypersensitivity to other corticosteroids. Local hypersensitivity reactions may resemble symptoms of the condition under treatment.
    Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamicpituitary-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.
    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 can be considered 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.
    Paediatric population: Children are more likely to develop local and systemic adverse reactions due to the use of local corticosteroids because of their higher surface area to body mass ratio and, in general, require a shorter treatment.
    Particularly, in infants and toddlers the diaper can be considered as an occlusive dressing and therefore can enhance absorption.
    In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal and growth suppression is more likely to occur.
    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.
    Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
    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.
    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.
    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.
    Accidental ingestion: For external use only. This and all medication should be kept out of the reach of children.
    In case of accidental ingestion, professional assistance should be sought or a national poison control centre contacted immediately.
    Eumovate Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.
    Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame.
    Patients should be warned of this risk and advised to keep away from fire when using this product.


    Side Effects

    For full details see prescribing information.


    Drug interactions

    Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
    The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.


    Pregnancy and Lactation

    Pregnancy: Administration of clobetasone during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
    Breast-feeding: It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.
    Administration of clobetasone during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
    If used during lactation, clobetasone should not be applied to the breasts to avoid accidental ingestion by the infant.
    See prescribing information for full details.


    Overdose

    Symptoms and signs: Topically applied clobetasone may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur.
    Treatment: In the event of overdose, clobetasone should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
    Further management should be as clinically indicated or as recommended by the national poisons centre, where available.


    Manufacturer
    Glaxo Operations UK Ltd
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