DIPROSALIC Ointment Ref.[27526] Active ingredients: Betamethasone Salicylic acid

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 those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and it is also effective in the less responsive conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis.

Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the epidermis.

Diprosalic presentations are therefore indicated for the treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid. The salicylic acid constituent of Diprosalic preparations, as a result of its descaling action, allows access of the dermis more rapidly than by applying steroid alone.

4.2. Posology and method of administration

Adults

Once to twice daily. In most cases a thin film should be applied to cover the affected area twice daily.

For some patients adequate maintenance therapy may be achieved with less frequent application.

It is recommended that Diprosalic preparations are prescribed for two weeks, and that treatment is reviewed at that time. The maximum weekly dose should not exceed 60 g.

Children

Dosage in children should be limited to 5 days.

4.9. Overdose

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing’s disease.

Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.

With topical preparations containing salicylic acid excessive prolonged use may result in symptoms of salicyclism. Treatment is symptomatic. Measures should be taken to rid the body rapidly of salicylate. Administer oral sodium bicarbonate to alkalinise the urine and force diuresis.

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

15, 30 or 100 gm expoxy-lined aluminium tubes with plastic caps.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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