DAKTACORT Cream Ref.[28074] Active ingredients: Hydrocortisone Miconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4 EG, UK

4.1. Therapeutic indications

For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema.

Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

Intertriginous eczema including inflammatory intertrigo, perianal and genital dermatitis.

Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

4.2. Posology and method of administration

For topical administration.

Apply the cream two or three times a day to the affected area, rubbing in gently until the cream has been absorbed by the skin.

The properties of Daktacort indicate it particularly for the initial stages of treatment. Because of its corticosteroid content avoid long-term treatment with Daktacort. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with miconazole nitrate 20 mg/g cream or miconazole nitrate 20 mg/g powder. Treatment should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks).

If after about 7 days' application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy.

The same dosage applies to both adults and children.

Elderly

Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.

Paediatrics

In infants and children, caution is advised when Daktacort is applied to extensive surface areas or under occlusive dressings including baby napkins (diapers). In infants, long term continuous topical corticosteroid therapy should be avoided (see Section 4.4).

4.9. Overdose

Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store in a refrigerator (2-8°C).

6.5. Nature and contents of container

Aluminium tube with polypropylene cap.

Each tube contains 5 g, 10 g, 15 g, 30 g or 75 g cream.

6.6. Special precautions for disposal and other handling

None.

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