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AUDAVATE is a brand name for Betamethasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Betamethasone valerate 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) Nummular dermatitis…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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 this medicine 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 betamethasone valerate 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 betamethasone valerate.
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. 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.
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 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Post-marketing data Infections and infestations Very rare:
Opportunistic infection.
Immune system disorders Very rare:
Hypersensitivity, generalised rash.
Endocrine disorders Very rare:
Hypothalamic-pituitary adrenal (HPA) axis suppression. 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.
4). General disorders and administration site conditions Very rare Application site irritation/pain. 4). *Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
Reporting of suspected adverse reactions:
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) • Increasing hydration of the stratum corneum • Use on thin skin areas such as the face • Use on broken skin or other conditions where the skin barrier may be impaired • 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 • Rosacea • Acne vulgaris • Pruritus without inflammation • Perianal and genital pruritus • Perioral dermatitis. Betamethasone valerate skin preparations are contraindicated in dermatoses in infants under one year of age, including dermatitis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Betamethasone in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
Method of administration Cutaneous
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.
If used in psoriasis careful patient supervision is important. Topical steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).
A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.
Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
Application to the face Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes; therefore, treatment courses should be limited to five days and occlusion should not be used. Application to the eyelids If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure.
Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Concomitant infection 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 administration of appropriate antimicrobial therapy.
Chronic leg ulcers Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
The label will state strong steroid.