Dermal Laboratories Limited

DIODERM™ 0.1% w/w CREAM

Hydrocortisone 0.1% w/w.

Smooth white aqueous cream.

For the topical treatment of eczema and dermatitis.

For adults, the elderly and children: apply to the affected areas twice daily. For infants: although generally regarded as safe, there is a potential for overdosage in infancy. Extreme caution is therefore required in dermatoses in infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed 7 days.

As with all topical steroids, Dioderm is not to be used where there is bacterial, viral or fungal infection.

Not to be used on open wounds, ulcers or broken skin.

Not to be used in cases of sensitivity to any of the ingredients.

Prolonged or extensive uninterrupted application should be avoided, particularly if used on the face or with occlusive dressings.

Keep away from the eyes.

None known.

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 known.

Reported side effects of corticosteroids include skin thinning and striae. Although rare, these could occur even with hydrocortisone, especially when used under occlusion or in the folds of the skin.

Dioderm is usually well tolerated although the excipient propylene glycol may on rare occasions cause skin irritation in sensitive people. In the rare event of skin irritation or a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued.

Under exceptional circumstances, if Dioderm is used excessively, particularly in young children, it is theoretically possible that adrenal suppression and skin thinning may occur. The symptoms are normally reversible on cessation of treatment.

Corticosteroids are used in pharmacological doses for their anti-inflammatory and immunosuppressive glucocorticoid properties which suppress the clinical manifestations of a wide range of diseases. Although many synthetic derivatives have been developed, hydrocortisone is still used widely in topical formulations for inflammatory dermatoses. It has the advantage over its synthetic derivatives that it is metabolised in the skin and therefore cannot accumulate to cause local side effects.

The cream formulation of Dioderm was developed in order to optimise the release and partition of its active ingredient, hydrocortisone, into the skin. The hydrocortisone is presented as a saturated or near saturated solution in aqueous propylene glycol, which represents the continuous phase of the emulsion system. It has been shown, by the vasoconstrictor assay on normal skin, that, in this environment, a 0.1% concentration of the hydrocortisone is equivalent to the 1.0% concentration of the official cream formulations appearing in the British Pharmacopoeia where the drug substance is in suspension. Clinical studies have confirmed that 0.1% Dioderm is equivalent to 1.0% Hydrocortisone Cream BP whilst the reduced strength of Dioderm increases the margin of safety.

The presentation of preclinical safety data is considered inappropriate due to the fact that the safety and efficacy of hydrocortisone in topical dosage forms has been well established over many years of widespread clinical usage.

Anhydrous Citric Acid; Emulsifying Ointment; Propylene Glycol; Purified Water.

Not applicable.

18 months.

Do not store above 25°C. Replace cap tightly after use.

30 g collapsible tube.

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

PA 278/3/1.

1 December 2005.

April 2008.