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DERMOVATE is a brand name for Clobetasol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clobetasol is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of steroid responsive dermatoses unresponsive to less potent corticosteroids. These include the following: • Psoriasis…
Verbatim from this product's MHRA label. Tap a section to expand.
4). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).
Route of administration:
Cutaneous Ointments are especially appropriate for dry, lichenified or scaly lesions. Adults, Elderly and Children over 1 year Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs (in the more responsive conditions this may be within a few days), 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. Repeated short courses of clobetasol propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film.
Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Treatment should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation should be used. The maximum weekly dose should not exceed 50gms/week. Therapy with clobetasol 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 clobetasol.
Recalcitrant dermatoses:
Patients who frequently relapse Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (once daily, twice weekly, without occlusion) may be considered. This has been shown to be helpful in reducing the frequency of relapse.
Application should be continued to all previously affected sites or to known sites of potential relapse. This regimen should be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be re-evaluated on a regular basis.
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycaemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis Skin and Subcutaneous Tissue Disorders Common Pruritus, local skin burning /skin pain Uncommon Skin atrophy*, striae*, telangiectasias* Very rare Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne\ Not known Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.
4) *Skin features secondary to local and/or systemic effects of hypothalamic- pituitary adrenal (HPA) axis suppression. General Disorders and Administration Site Conditions Very rare Application site irritation/pain Eye disorders Very rare Cataract, central serous chorioretinopathy, glaucoma Not known (cannot be estimated from available data) Vision, blurred Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the risk/benefit balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
2). g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. 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.
8) 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. 8). g. on intertriginous areas or under occlusive dressings (in infants the nappy may act 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.
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 five days and reviewed weekly. Occlusion should not be used.
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.
1. The following conditions should not be treated with clobetasol: • Untreated cutaneous infections • Rosacea • Acne vulgaris • Pruritus without inflammation • Perianal and genital pruritus • Perioral dermatitis. Clobetasol is contraindicated in dermatoses in children under one year of age, including dermatitis and nappy eruptions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paediatric population Clobetasol is contraindicated in children under one year of age. 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 five days and reviewed weekly.
Occlusion should not be used. Application to the face Courses should be limited to five days if possible and occlusion should not be used. 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.
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. 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.
Application to the face Application to the face is undesirable as this area is more susceptible to atrophic changes. If used on the face, treatment should be limited to only 5 days. 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.
If clobetasol does enter the eye, the affected eye should be bathed in copious amounts of water. Visual disturbance Visual disturbance has been 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.
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.
Dermovate Ointment contains 50 mg propylene glycol per gram of product. Propylene glycol may cause skin irritation. Clobetasol ointment contains paraffin. Instruct patients not to smoke or go near naked flames due to the 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. Topical steroid withdrawal syndrome 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 […]