Clobeson is suitable for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.

Clobeson may be used as maintenance therapy between courses of one of the more active topical steroids.

Route of administration: Topical application For all ages:

Clobeson should be applied to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.

Hypersensitivity to the preparations.

Although generally regarded as safe, even for long-term administration in adults, there is a potential for overdosage, and in infants and children this may result in adrenal suppression. Extreme caution is required in dermatoses in such patients and treatment should not normally exceed seven days. In infants, the napkin may act as an occlusive dressing, and increase absorption.

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 systemic administration of antimicrobial agents.

As with all corticosteroids, prolonged application to the face is undesirable.

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.

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as glaucoma might result.

None stated

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 intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

None stated

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common ( ≥1/10), common ( ≥1/100 and <1/10), uncommon ( ≥1/1000 and <1/100), rare ( ≥1/10,000 and <1/1000) and very rare ( <1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. The background rates in placebo and comparator groups were not taken into account when assigning frequency categories to adverse events derived from clinical trial data, since these rates were generally comparable to those in the active treatment group. Rare and very rare events were generally derived from spontaneous data.

Immune System Disorders

Very rare: Hypersensitivity

Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria, local skin burning and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment.

In the unlikely event of signs of hypersensitivity appearing, application should stop immediately.

Endocrine Disorders

 Very rare: Adrenal suppression

When large areas of the body are being treated with clobetasone 17-butyrate, it  is possible that some patients will absorb sufficient steroid to cause transient adrenal suppression despite the low degree of systemic activity associated with clobetasone 17- butyrate.

Skin and Subcutaneous Tissue Disorders

 Very rare: Skin atrophy, pigmentation changes, hypertrichosis

Local atrophic changes could possibly occur in situations where moisture increases absorption of clobetasone 17-butyrate, but only after prolonged use.

General Disorders and Administration Site Conditions

Very rare: Exacerbation of underlying symptoms

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisol may appear and in this situation topical steroids should be reduced or discontinued gradually under medical supervision because of the risk of adrenal insufficiency.

Clobetasone butyrate is a topically active corticosteroid.

Clobetasone butyrate has little effect on hypothalamo-pituitary-adrenal function. This was so even when Clobeson was applied to adults in large amounts under whole body occlusion.

Clobetasone butyrate is less potent than other available corticosteroid preparations and has been shown not to suppress the hypothalamo-pituitary-adrenal axis in patients treated for psoriasis or eczema.

Pharmacological studies in man and animals have shown that clobetasone butyrate has a relatively high level of topical activity accompanied by a low level of systemic activity.

A single application of 30g clobetasone butyrate 0.05% ointment to eight patients resulted in a measurable rise in plasma clobetasone butyrate levels during the first three hours but then the levels gradually decreased. The maximum plasma level reached in the first three hours was 0.6ng/ml. This rise in levels was followed by a more gradual decline with plasma levels of clobetasone butyrate falling below 0.1ng/ml (the lower limit of the assay) after 72 hours. The normal diurnal variation in plasma cortisol levels was not affected by the application of clobetasone butyrate ointment.

No additional data included

Excipients are Light Liquid Paraffin, Cetostearyl Alcohol, Cetomacrogol Emulsifying Wax, Chlorocresol, Purified Water, Sodium Dihydrogen Phosphate Anhydrous, Anhydrous Disodium Hydrogen Phosphate, Glycerol and White Soft Paraffin.

None

Store below 30°C.

KEEP OUT OF THE REACH OF CHILDREN

Aluminium Collapsible Tubes

No special requirements.