Merck Sharp & Dohme Ireland (Human Health) Limited

Diprosalic 0.05 % w/w + 3 % w/w Ointment

0.05% w/w Betamethasone (as dipropionate)

3.00% w/w Salicylic acid

For a full list of excipients, see section 6.1.

Ointment

A smooth, off-white ointment

Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. In combination with salicylic acid it is indicated for the treatment of chronic lichenified eczema, lichen planus, lichen simplex and non bullous ichthyosiform 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.

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

Adults:

Once to twice daily. In most cases a thin film should be applied to cover the affected area once or 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 60g.

Children:

Dosage in children should be limited to 5 days.

Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Diprosalic preparations contra-indicates their use as does tuberculous and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. Diprosalic should not be used in napkin eruptions, fungal or bacterial skin infections without suitable concomitant anti-infective therapy.

Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid.

Local and systemic toxicity is common, especially following long continuous use on large areas of damaged skin, in flexures or with polythene occlusion. Long term continuous therapy should be avoided in all patients irrespective of age. If used in children or on the face courses should be limited to 5 days.

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

There have been a few reports in the literature of the development of cataracts in patients who have been using corticosteroids for prolonged periods of time. Although it is not possible to rule out systemic corticosteroids as a known factor, prescribers should be aware of the possible role of corticosteroids in cataract development.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.

The systemic absorption of betamethasone dipropionate and salicylic acid may be increased if extensive body surface areas or skin folds are treated for prolonged periods or with excessive amounts of steroids. Suitable precautions should be taken in these circumstances, particularly with infants and children.

None stated.

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 intrauterine growth retardation.

There may therefore be a very small risk of such effects in the human foetus. Diprosalic skin preparations should not be used in pregnancy and lactation unless considered essential by the physician.

None stated.

Diprosalic skin preparations are generally well tolerated and side-effects are rare.

Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face.

In addition, prolonged use of salicylic acid preparations may cause dermatitis.

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.

With topical preparations containing salicylic acid excessive prolonged use may result in symptoms of salicyclism. Treatment is symptomatic.

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.

Diprosalic preparations contain the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties of corticosteroids, and salicylic acid which has keratolytic properties.

Salicylic acid is applied topically in the treatment of hyperkeratotic and scaling conditions where its keratolytic action facilitates penetration of the corticosteroid.

In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory and/or immune suppressive effects.

Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of a range of dermatoses because of their anti-inflammatory, anti-pruritic and vasoconstrictive actions. However, while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanisms of their action in each disease are uncertain.

Salicylic acid exerts only local action after topical application.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal barrier and the use of occlusive dressings.

Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolised primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted in the bile.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Liquid Paraffin

White Soft Paraffin

Not applicable.

5 years

Do not store above 25°C.

Epoxy-lined aluminium tubes with plastic caps, containing 30g or 100g of ointment.

No special requirements.

Merck Sharp & Dohme Ireland (Human Health) Limited

Pelham House

South County Business Park

Leopardstown

Dublin 18

Ireland

PA 1286/29/2

27 October 1983 / 16 March 2007

26 November 2010

Prescription Only Medicine

© Merck Sharp & Dohme Limited 2011. All rights reserved.

DiprosalicO/Irl/04-11/03