Betnovate Scalp Application.

Betamethasone Valerate BP 0.122% ^w/w.

Aqueous Suspension.

Steroid responsive dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis.

A small quantity of Betnovate Scalp Application should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.

For topical application.

Infections of the scalp. Hypersensitivity to the preparation. Dermatoses in children under one year of age, including dermatitis.

Care must be taken to keep the preparation away from the eyes. Does not use near a naked flame.

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).

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.

Development of secondary infection requires withdrawal of topical corticosteroid therapy and commencement of appropriate systemic antimicrobial therapy.

The least potent corticosteroid which will control the disease should be selected. The viscosity of the scalp application has been adjusted so that the preparation spreads easily without being too fluid. The specially-designed bottle and nozzle allow easy application direct to the scalp through the hair.

None known.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

There have been no studies to investigate the effect of betamethasone valerate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical betamethasone valerate.

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.

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.

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.

Absorption

Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Distribution

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary because circulating levels are well below the level of detection.

Metabolism

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver.

Elimination

Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Reproductive toxicity

Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 micrograms/kg/day during pregnancy produced foetal abnormalities including cleft palate and intrauterine growth retardation.

The effect on fertility of betamethasone valerate has not been evaluated in animals.

Carbomer

Isopropyl Alcohol

Sodium Hydroxide

Purified Water

None known.

24 months.

Store below 25°C

Polyethylene squeeze bottle with a polyethylene nozzle and a polystyrene or polyethylene cap or white High Density Polyethylene (HDPE) Hostalen GF4750 and Remafin white CEG 020 container with a polyethylene nozzle and a polystyrene or polyethylene cap.

Pack size: 30ml; 100ml

Not all pack sizes may be marketed

No special instructions.

Glaxo Wellcome UK Limited

trading as GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

PL 10949/0045.

9 December 1997

2 September 2011

POM