INFORMATION FOR HEALTH PROFESSIONALS
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Dermol Cream and Ointment each contain 0.05% w/w clobetasol propionate. The water-miscible cream and the paraffin-based ointment are both white in appearance.
Clobetasol propionate is a very active topical corticosteroid which is of particular value when used in short courses for conditions which do not respond satisfactorily to less active steroids.
Percutaneous penetration of clobetasol propionate varies among individuals and as with other topical corticosteroids, sufficient clobetasol propionate may be absorbed to give systemic effects especially if applied under an occlusive dressing or when the skin is broken.
Mean peak plasma clobetasol propionate concentrations of 0.63ng/mL occurred in one study eight hours after the second application (13 hours after an initial application) of 30g clobetasol propionate 0.05%ointment to normal individuals with healthy skin. Following the application of a second dose of 30g clobetasol propionate cream 0.05% mean peak plasma concentrations were slightly higher than the ointment and occurred 10 hours after application. In a separate study, mean peak plasma concentrations of approximately 2.3ng/mL and 4.6ng/mL occurred respectively in patients with psoriasis and eczema three hours after single application of 25g clobetasol propionate 0.05% ointment.
Following percutaneous absorption of clobetasol propionate the drug probably follows the metabolic pathway of systemically administered corticosteroids. However, systemic metabolism of clobetasol has never been fully characterised or quantified. [The above findings are based on the brand leader (DERMOVATE) datasheet, Issue 10, March 2002]
Treatment of resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant eczemas, lichen planus and discoid lupus erythematosus and other skin conditions which do not respond satisfactorily to less active steroids.
Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved. In the more responsive conditions this may be within a few days.
If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary.
Repeated short courses of CLOBETASOL PROPIONATE may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of CLOBETASOL PROPIONATE 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.
Rosacea, acne vulgaris and perioral dermatitis. Primary cutaneous viral infections (e.g. herpes simplex, chickenpox).
Hypersensitivity to the preparation.
The use of CLOBETASOL PROPIONATE skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea), or bacteria (e.g. impetigo): perianal and genital pruritus.
Dermatoses in children under one year of age, including dermatitis and napkin eruptions.
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion.
If used in childhood or on the face, courses should be limited if possible to five days and occlusion should not be used.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma or cataract might result.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.
Appropriate anti-microbial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of anti-microbial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.
Pregnancy:
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. The relevance of this finding to human beings has not been established, however, topical steroids should not be used extensively in pregnancy, i.e., in large amounts for prolonged periods. There may be a very small risk of abnormal foetal development in the human foetus.
As with other topical corticosteroids prolonged use of large amounts, or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism.
Provided the weekly dosage is less than 50 g in adults, any suppression of the HPA axis is likely to be transient with a rapid return to normal values once the short course of steroid therapy has ceased. The same applies to children given proportionate dosage. Use of occlusive dressing increases the absorption of topical corticosteroids. In infants the napkin may act as an occlusive dressing.
Prolonged and intensive treatment with a highly active corticosteroid preparation may cause local atrophic changes in the skin such as thinning, striae and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.
There are reports of pigmentation changes and hypertrichosis with topical steroids.
CLOBETASOL PROPIONATE is usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately.
Exacerbation of symptoms may occur.
Nil.
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the symptoms of severe adrenal suppression and hypercorticism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk of acute adrenal suppression this should be done under medical supervision.
Store below 25°C, out of direct sunlight.
Prescription Medicine.
Tubes of 30 g
The least potent corticosteroid which will control the disease should be selected.
Mylan New Zealand Limited
PO Box 11-183
Ellerslie
AUCKLAND
Telephone 09-579-2792
2 February 2009