Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
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:
Clobetasol propionate belongs to the most potent class of topical corticosteroids (Group IV) and prolonged use may result in serious undesirable effects (see section 4.4). 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).
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.
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.
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.
Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be used.
Courses should be limited to five days if possible and occlusion should not be used.
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.
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.
Medodermone is used for cutaneous administration.
Creams are especially appropriate for moist or weeping surfaces.
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 (see section 4.8).
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.
36 months.
Store below 25°C in the original package, in order to protect from moisture.
PVC screwed-cap pilferproof aluminium tubes of 15 g and 25 g.
Not all pack sizes may be marketed.
No special requirements.
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