GlaxoSmithKline (Ireland) Ltd

Betnovate RD (Ready Diluted) 0.025% w/w Ointment

Betamethasone 0.025% w/w (as Betamethasone valerate).

For a full list of excipients, see section 6.1

Ointment.

A smooth, off-white soft-paraffin based ointment

Betamethasone is indicated in the topical management of corticosteroid responsive dermatoses such as eczema in children and adults, including atopic and discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), neurodermatoses, including lichen simplex, lichen planus, seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalized erythroderma.

Betamethasone Valerate is a potent glucocorticoid absorbed in part after topical use. Betnovate RD preparations are indicated for maintenance treatment when control has been achieved with Betnovate.

Application to the affected area usually one to three times daily, or as directed by the physician.

When improvement occurs frequency of use should be gradually reduced.

Betnovate RD ointment is especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so.

Rosacea, acne vulgaris, primary cutaneous viral infections, perianal and genital pruritus and peri-oral dermatitis.

Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.

Use in primary cutaneous viral infections (e.g. herpes simplex, chickenpox). Hypersensitivity to any ingredients of the preparations.

Dermatoses in children under one year of age, including dermatitis and napkin eruptions. Widespread plaque psoriasis except single lesions.

Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressing may suppress adrenocortical function. Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression or of growth suppression, systemic absorption and hypercorticism.

The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

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

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses on cessation of use, development of tolerances, risk of generalized pustular psoriasis, excessive systemic absorption and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

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.

None known.

Animal studies with corticosteroids have shown teratogenic effects. To date similar effects have not been shown to occur in man. This product should not be used during pregnancy or lactation unless considered essential by the physician.

None known.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. The background rates in placebo and comparator groups were not taken into account when assigning frequency categories to adverse events derived from clinical trial data, since these rates were generally comparable to those in the active treatment group. Rare and very rare events were generally determined from spontaneous data.

Immune system disorders

If signs of *hypersensitivity appear, application should stop immediately.

Endocrine disorders

*As with other corticosteroids, prolonged use of large amounts or treatment of extensive areas, can result in sufficient systemic absorption to produce the *features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.

Vascular disorders

*Prolonged and intensive treatment with highly active corticosteroid preparations may cause *dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.

Skin and subcutaneous tissue disorders

*Prolonged and intensive treatment with highly active corticosteroid preparations may cause *local atrophic changes in the skin such as *thinning, and *striae, particularly when occlusive dressings are used or when skin folds are involved.

In very rare instances, treatment of psoriasis with corticosteroid (or its withdrawal) is thought to have provoked the pustular form of the disease.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticisolism may appear and in this situation topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency.

Betamethasone valerate is a corticosteroid with topical anti-inflammatory activity.

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

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings on the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.

No additional data.

White Soft Paraffin,

Liquid Paraffin.

Not applicable

3 years.

Do not store above 25^oC. Store in the original package in order to protect from light.

Betnovate RD ointment is supplied in 100g collapsible aluminium tubes.

No special requirements

GlaxoSmithKline (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16

PA 1077/1/5

24^th August 1984 / 24^th August 2009

March 2010