Betnovate Cream

Betamethasone Valerate BP 0.122% ^W/_W

Aqueous Cream

Betamethasone valerate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and is often effective in the less responsive conditions such as psoriasis.

Betnovate preparations are indicated for the treatment of 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 generalised erythroderma.

A small quantity of Betnovate should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often, or by using the appropriate ready-diluted (1 in 4) preparation Betnovate R.D. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary.

Betnovate and Betnovate R.D. creams are especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so.

In the more recent resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betnovate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions; thereafter improvement can usually be maintained by regular application without occlusion.

Children

Courses should be limited to five days. Occlusion should not be used.

For topical administration.

Rosacea, acne and perioral dermatitis. Primary cutaneous viral infections (e.g. herpes simplex, chickenpox). Hypersensitivity to any component of the preparation.

The use of Betnovate skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infections with fungi (e.g. candidiasis, tinea); or bacteria (e.g. impetigo); primary or secondary infections due to yeast; peri-anal and genital pruritus; dermatoses in children under 1 year of age, including dermatitis and napkin eruptions.

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing's syndrome, can occur even without occlusion. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see section 4.8 Undesirable Effects and Section 4.9 Overdose).

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.

If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis 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.

Further Information

The least potent corticosteroid which will control the disease should be selected. None of these preparations contain lanolin. Betnovate Cream and Ointment and the corresponding RD preparations do not contain parabens. Betnovate Lotion contains parabens.

None known.

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 intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

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

Very rare: Hypersensitivity.

If signs of hypersensitivity appear, application should stop immediately.

Endocrine disorders

Very rare: Features of Cushing's syndrome

As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce suppression of the HPA axis and the clinical features of Cushing's syndrome (see Section 4.4 Special Warnings and Precautions for use). These effects are more likely to occur in infants and children, and if occlusive dressings are used. In infants the napkin may act as an occlusive dressing.

Skin and subcutaneous tissue disorders

Common: Local skin burning and pruritus.

Very rare: Local atrophic changes in the skin such as thinning, striae and dilatation of the superficial blood vessels may be caused by prolonged and intensive treatment with highly active corticosteroid preparations, particularly when occlusive dressings are used or when skin folds are involved.

Pigmentation changes, hypertrichosis, allergic contact dermatitis, exacerbation of symptoms, pustular psoriasis (due to treatment of psoriasis with corticosteroids or its withdrawal: see Section 4.4. Special Warnings and Precautions for use)

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing's syndrome may appear and in this situation topical steroids should be discontinued gradually under medical supervision (see Section 4.4 Special Warnings and Precautions for use).

Betamethasone valerate is an active 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.

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.

None known.

Store below 25°C.

15gm, 30gm and 100gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a cap.

500mg opaque high density polythene pots with black urea formaldehyde screw caps having a steran faced wad.

Not all pack sizes may be marketed

No special instructions.

Glaxo Wellcome UK Ltd.,

T/A GlaxoSmithKline UK

Stockley Park West,

Uxbridge,

Middlesex UB11 1BT

PL10949/0014

24 October 1997

25th January 2005