DIODERM 0.1% W/W CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dioderm 0.1 w/w Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone 0.1% w/w

For excipients see Section 6.1

3. PHARMACEUTICAL FORM

Smooth white aqueous CREAM.

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

For the topical treatment of eczema and dermatitis.

4.2. Posology and Method of Administration

For adults, the elderly and children

Apply to the affected areas twice daily. For infants, the treatment period should not normally exceed 7 days.

4.3 Contra-Indications

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.

4.4 Special warnings and special precautions for use

Although generally regarded as safe, even for long-term administration in adults, there is a potential for overdosage in infancy. Extreme caution is required in dermatoses in infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed 7 days.

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

The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people.

Keep out of the reach and sight of children.

Keep away from the eyes.

For external use only.

4.5. Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6. Pregnancy and Lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

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 but in the event of a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

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.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

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 form a depot which may result in local side effects.

5.2. Pharmacokinetic Properties

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.

5.3. Pre-clinical Safety Data

No special information.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid

Emulsifying wax

White soft paraffin

Liquid paraffin

Propylene glycol

Purified water

6.2. Incompatibilities

None known.

6.3 Shelf life

24 months in unopened container.

6.4. Special Precautions for Storage

Do not store above 25°C.

Replace cap tightly after use.

6.5. Nature and Content of Container

30 g, 50 g and 100 g membrane sealed epoxy resin coated aluminium collapsible TUBES. High density polyethylene white spiked flowerpot SCREW CAPS inverted over the orifice to break the seal. Supplied as original packs (OP).

6.6. Instructions for Use, Handling and Disposal

Not applicable.

Diomed Developments Limited T/A Dermal Laboratories Tatmore Place, Gosmore Hitchin

Herts, SG4 7QR

UK

8. MARKETING AUTHORISATION NUMBER

PL 0173/0047

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

16 December 1987 / 24 February 1998