BETNOVATE RD

Route of administration:

Cutaneous Creams are especially appropriate for moist or weeping surfaces. Once an acute episode has been treated effectively with a continuous course of betamethasone valerate, improvement may be maintained with a small amount of ready diluted betamethasone valerate applied once or twice a day.

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. Paediatric population Betamethasone valerate 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 betamethasone valerate 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.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.

g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis Skin and Subcutaneous Tissue Disorders Common Pruritus, local skin burning /skin pain Very rare Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning* / skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation changes*,hypertrichosis, exacerbation of underlying symptoms Not known Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.

4) General Disorders and Administration Site Conditions Very rare Application site irritation/pain *Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression. 4) Reporting of suspected reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Betamethasone valerate should be used with caution in patients with a history of local hypersensitivity to other corticosteroids. 8) may resemble symptoms of the condition under treatment. Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids.

If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. 8). g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing) o Increasing hydration of the stratum corneum o Use on thin skin areas such as the face o Use on broken skin or other conditions where the skin barrier may be impaired o In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.

This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. Paediatric population In infants and children under 12 years of age, treatment courses should be limited to five days and occlusion should not be used; long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.

Infection risk with occlusion Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.

Use in Psoriasis Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases.

1. The following conditions should not be treated with betamethasone valerate: • Untreated cutaneous infections o Rosacea o Acne vulgaris o Pruritus without inflammation o Perianal and genital pruritus o Perioral dermatitis Betamethasone valerate is contraindicated in dermatoses in infants under one year of age, including dermatitis.