Composition

Each 100 g contains:
Betamethasone (as valerate) .......................................................... 0.1 g
Inactive ingredients:
BETADERM Cream: Cetostearyl alcohol, sodium lauryl sulfate, white soft paraffin, sodium phosphate monobasic, chlorocresol, propylene glycol, purified water, heavy liquid paraffin.
BETADERM Ointment: Cetostearyl alcohol, white soft paraffin, propylene glycol, white bees wax, hard paraffin, heavy liquid paraffin.

Therapeutic Indications

BETADERM is a potent topical corticosteroid indicated for adults, elderly and children over 1 year, for the relief of the inflammatory and pruritic manifestations of steroid-responsive dermatoses. These include the following:
Atopic dermatitis (including infantile atopic dermatitis).
Seborrhoeic dermatitis.
Irritant or allergic contact dermatitis.
Nummular dermatitis (discoid eczema).
Prurigo nodularis.
Psoriasis (excluding widespread plaque psoriasis).
Lichen simplex chronicus (neurodermatitis) and lichen planus.
Discoid lupus erythematosus.
Adjunct to systemic steroid therapy in generalised erythroderma.
Insect bite reactions.

Dosage and Administration

Route of administration: Cutaneous.
Creams are especially appropriate for moist or weeping surfaces.
Ointments are especially appropriate for dry, lichenified or scaly lesions.
Apply thinly and gently rub in, using only enough to cover the entire affected area, once or twice daily for up to 4 weeks until improvement occurs; then reduce the frequency of application or change the treatment to a less potent preparation.
Allow adequate time for absorption after each application before applying an emollient.
In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of BETADERM 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.
If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Therapy with BETADERM should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of BETADERM.
Recalcitrant Dermatoses:
Patients who frequently relapse: Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (apply once a day twice a week without occlusion) may be considered. This has been shown to be helpful in reducing the frequency of relapse.
Application should be continued to all previously affected sites or to known sites of potential relapse. This regimen should be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be re-evaluated on a regular basis.
Pediatric population:
BETADERM is contraindicated in children under one year of age.
Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults; therefore, courses should be limited to five days and occlusion should not be used. Care should be taken when using BETADERM to ensure the amount applied is the minimum that provides therapeutic benefit.
Elderly:
Clinical studies have not identified differences in responses between the elderly and younger patients.
The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal/Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period), metabolism and elimination may be delayed, therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.