Cream and Ointment
Clobetasol propionate

Dermovate 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.

Mode of Action
Clobetasol 17-propionate is a highly active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy.
Corticosteroids, with the exception of deoxycortone, are absorbed from the gastrointestinal tract. When administered by topical application, particularly under an occlusive dressing or when the skin is broken,
sufficient corticosteroid may be absorbed to give systemic effects.
Corticosteroids in the circulation are extensively bound to plasma proteins, mainly to globulin and also to albumin.
The corticosteroids binding globulin has high affinity but low binding capacity, while the albumin has low affinity but large binding capacity.
Only unbound corticosteroid has pharmacological effects or is metabolised.
The synthetic corticosteroids are less extensively protein bound than hydrocortisone (cortisol). They also tend to have longer half-lives.
Corticosteroids are metabolised mainly in the liver but also in the kidney, and are excreted in the urine. The slower metabolism of the synthetic corticosteroids with their lower protein binding affinity may account for their increased potency compared with the natural corticosteroids.

Clobetasol propionate is a very active topical corticosteroid which is of particular value when used in short courses for the treatment of the more resistant dermatoses such as psoriasis (excluding widespread plaque
psoriasis), recalcitrant eczema, lichen planus, discoid lupus erythematosus and other conditions which do not respond satisfactorily to less active steroids.

Dosage and Administration
Apply sparingly to the affected area once or twice daily until improvement occurs and discontinue when control is achieved. In the more responsive conditions this may be within a few days. Treatment should not be continued for more than four weeks without the patient's condition being reviewed. Repeated short courses of Dermovate 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 Dermovate 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 and perioral dermatitis. Perianal and genital pruritus. Skin lesions caused by infection with viruses (eg herpes simplex, chickenpox).
Hypersensitivity to the preparation.
The use of Dermovate skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria.
Dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Long-term continuous therapy with Dermovate should be avoided particularly in infants and children, in whom adrenal suppression occurs readily. If Dermovate is required for use in children, or on face, courses should be limited if possible to five days and occlusion should not be used. It should be noted that the infant's napkin may act as an occlusive dressing.
The face, more than other areas of the body, may exhibit atrophic change after prolonged treatment with potent topical corticosteroid. This must be borne in mind when treating facial conditions which warrant use of Dermovate, and frequent observation of the patient is important. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.
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 institutional of suitable systemic chemotherapy.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
Topical administration of corticosteroid to pregnant animals can caused abnormalitis of fetal development including cleft palate and intra-uterine growth retardation. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, ie. in large amounts or for prolonged periods.
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. As with other topical corticosteroid, prolonged use of large amounts, or treatment of extensive areas can result in sufficient systemic absorption to produce
the feature of hypercorticism.

Provided the weekly dosage is less than 50 g in adults, any pituitary-adrenal suppression is likely to be transient with a rapid return to normal values once the short courses of steroid therapy has ceased. The same
applies to children given proportionate dosage. Use ofocclusive dressings increases the absorption of topical corticosteroid.
Prolonged and intensive treatment with highly active corticosteroid preparations may cause atrophic changes, such as striae, thinning of the skin, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved.
There are reports of pigmentation changes and hypertrichosis with topical steroids.
In rare instances, treatment of psoriasis with corticosteroid (or its withdrawal) is thought to have provoked the pustular form of the disease.
Dermovate is usually well tolerated, but if signs of hypersensitivity appear application should be stopped immediately. Exacerbation symptoms may occur.

Drug Interactions
Standard works on adverse reactions and drug interactions are routinely examined; no firm effects other than those mentioned in this application have been found.

Legal Category
On medical prescription only.

Package Quantities and Registration Number
Dermovate Cream, 5 g tube, Reg. No. DKL9232000429A1
Dermovate Cream, 10 g tube, Reg. No. DKL9232000429A1
Dermovate Ointment, 10 g tube, Reg. No. DKL9232000330A1

Further Information
The least potent corticosteroid which will control the disease should be selected.
Dermovate preparations contain neither lanolin nor parabens.

Store below 25°C

Manufactured by
PT. Glaxo Wellcome Indonesia
Jakarta, Indonesia

™Dermovate is a trade mark of the GlaxoSmithKline group of companies

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