DIPROSONE Cream Ref.[27513] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

4.1. Therapeutic indications

Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in eczema and dermatitis of all types, including atopic eczema, photodermatitis, lichen planus, lichen simplex, prurigo nodularis, discoid lupus erythematosus, necrobiosis lipoidica, pretibial myxodemea and erythroderma. It is also effective in the less responsive conditions such as psoriasis of the scalp and chronic plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis.

4.2. Posology and method of administration

Adults and Children

Once to twice daily. In most cases a thin film of Diprosone Cream should be applied to cover the affected area twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application.

Diprosone Cream is especially appropriate for moist or weeping surfaces and the ointment for dry, lichenifield or scaly lesions but this is not invariably so.

Control over the dosage regimen may be achieved during intermittent and maintenance therapy by using Diprobase Cream or Ointment, the base vehicles of Diprosone Cream and Ointment. Such control may be necessary in mild and improving dry skin conditions requiring low dose steroid treatment.

4.9. Overdose

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic treatment is indicated. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or to substitute a less potent steroid.

The steroid content of each tube is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

5, 30 or 100 g expoxy-lined aluminium tubes with polypropylene caps.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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