Moderately potent corticosteroids (topical steroids) / hydrating agents.

Hydrocortisone/urea

Alphaderm cream contains the active ingredients Hydrocortisone, PhEur 1% w/w and Urea, BP 10% w/w.

Translucent white cream.

For the treatment of all dry ichthyotic, eczematous conditions of the skin, including atopic, infantile, chronic allergic and irritant eczema, asteatotic, hyperkeratotic and lichenified eczema, neurodermatitis and prurigo.

Adults, children and the elderly. A small amount should be applied topically to the preferably dry affected areas twice daily. In resistant lesions occlusive dressings may be used but this is usually unnecessary because of the self occlusive nature of the special base.

Primary bacterial, viral and fungal diseases of the skin and secondarily infected eczemas or intertrigo acne, perioral dermatitis, rosacea and, in general, should not be used on weeping surfaces.

Known hypersensitivity to the active ingredients or any of its excipients.

Caution should be exercised when using in children. In infants and children, long term continuous therapy should be avoided, as adrenal suppression can occur even without occlusion. Excessive absorption may occur when applied under napkins. Where possible treatment in infants should be limited to 5-7 days.

Application to moist or fissured skin may cause temporary irritation.

As with corticosteroids in general, prolonged application to the face and eyelids is undesirable and the cream should be kept away from the eyes.

If used correctly Alphaderm is unlikely to cause side effects. However, the following events have been observed with topical steroids, and although are rare with hydrocortisone, may occur, especially with long-term use; spread and worsening of untreated infection; thinning of the skin; irreversible striae atrophicae and telangiectasia; contact dermatitis, perioral dermatitis; acne; mild depigmentation which may be reversible. Atrophic changes may occur in intertriginous areas or nappy areas in young children.

Alliance Pharmaceuticals

(POM)

04 June 2009