Each gram of Betamethasone cream for external use contains:
active ingredient: betamethasone [as valerate] – 1 mg;
For a full list of excipients, see section 6.1
Drug formSoft
ATC categoryGlucocorticoids
ATC subcategoryGlucocorticoids for external use
Brand nameBetamethasone
Generic nameBetamethasone
Each gram of Betamethasone cream for external use contains:
active ingredient: betamethasone [as valerate] – 1 mg;
For a full list of excipients, see section 6.1
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
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 betamethasone valerate 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. 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.
ATC code D07AC01; Corticosteroids, potent (group III)
List of excipients
ceteareth-12
ceteareth-20
cetostearyl alcohol
liquid paraffin
propylene glycol
dimethicone
methylparaben
propylparaben
ethanol
water purified.
For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134296/1732701222744.pdf