Dermovate Scalp Application

/ GSK

Route of administration: Topical, on the scalp.
Owing to the flammable nature of the product, Dermovate Scalp Application should be kept away from open fire and flames and all sources of ignition, including smoking, during and immediately after use.
Adults, Elderly and Children over 1 year: A small quantity of clobetasol should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.
Paediatric population: Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Care should be taken when using clobetasol propionate to ensure the amount applied is the minimum that provides therapeutic benefit.
Duration of treatment for children and infants: Courses should be limited if possible to a few days and reviewed weekly.
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.

For the topical treatment of inflammatory conditions of the scalp responsive only to corticosteroids.

Infections of the scalp.
Hypersensitivity to the active substance or any of the excipients.
Dermatoses in children under one year of age, including dermatitis.

Care must be taken to keep the preparation away from the eyes.
Patients should be advised to avoid:
– smoking whilst applying to the scalp
– fire, flame and heat including use of hair dryer after application.
Clobetasol 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 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.
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)
– Increasing hydration of the stratum corneum
– Use on thin skin areas
– 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.
Paediatric population: 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 a few days and reviewed weekly.
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.
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.

Common: Pruritus, local skin burning/skin pain.
See prescribing information for full details.

Co-administered drugs that can inhibit CYP3A4 (eg ritonavir and 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: There are limited data from the use of clobetasol in pregnant women. Administration of clobetasol 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.
Lactation: The safe use of topical corticosteroids during lactation has not been established. 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 clobetasol during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant. If used during lactation clobetasol should not be applied to the breasts to avoid accidental ingestion by the infant.
See prescribing information for full details.

Symptoms: Topically applied clobetasol 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.
Management: In the event of overdose, clobetasol 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.

Storage: Do not Store above 25°C.
Use within 3 months after opening.
Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat. Do not leave Dermovate Scalp Application in direct sunlight.