BETNOVATE N CREAM; betamethsone, neomycin, dermatological agents .
ACTIVE-INGREDIENT OF BETNOVATE N CREAM
IT CONTAIN 0.122 % w/w betamethasone 17-valerate with 0.5% w/w neomycin sulphate .
INDICATION OF BETNOVATE N CREAM
betamethasone valerate is a potent topical corticosteriod indicated for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses . Neomycin sulphate is an aminoglycoside broad spectrum antibiotic . Topical preparations combining betamethasone valerate and neomycin sulphate are indicated for the treatment of the following conditions where secondary bacterial infection is present , suspected , or likely to occur :- atopic dermatitis . – nummular dermatitis ( discoid eczema ) – prurigo nodularis .- psoriasis( excluding widespread plaque psoriasis ) .- lichen simplex chronicus ( neurodermatitis) and lichen planus .- seborrhoeic dermatits – initial or allergic contact dermatitis – insect bite reactions .- miliaria (pickly heat ) .- anal and genital intertrigo. – otitis externa.
DOSAGE OF BETNOVATE N CREAM
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
BETNOVATE N CREAM is especially appropriate for dry ,lichenified or scaly lesions . Adults and adolescents : apply a thinly and gently rub in using enough to cover the entire affected area once or twice daily for up to seven days , then change to another corticosteriod preparation not containing neomycin sulphate if further treatment is required .
allow adequate time for absorbtion after each application before applying an emolient . in the more resistant lesions , such as the thickened plaques of psoriasis on elbows and knees , the effect of betnovate N can be enhanced , if necessary , by occluding the treatment area with polythenefilm .
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 . treatment should not be continued for more than seven days without medical supervision .
if the condition worsens or does not improve within seven days , treatment and diagnosis should be re-evaluated . children aged 2 years and over : betnovate N is suitable for use in children ( 2 years and over ) at the same dose as adults .
a possibility of increased absorption exists in very young children , thus betnovate N is contraindicated in neonates and infants ( less than 2 years ) .
children are more likely to develop local and systemic side effects of topical corticoseroids and , in general , require shorter courses and less potent agents than adults . care should be taken when using BETNOVATE N to ensure the amount applied is the minimum that provides therapeutic benefit . – elderly : BETNOVATE N is suitable for use in the elderly .
clinical studies have not identified difference in responses between the elderly and younger patients . the greater frequancy of decreased hepatic and 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 impairment : dosage should be reduced in patients with reduced renal function .
OVER-DOSAGE OF BETNOVATE N CREAM
symptoms and signs : topically applied betamethasone valerate may be absorped in sufficient amounts to produce systemic effects , acute overdosage is very unlikely to occur , however , in the case of chronicoverdosage or misuse the features of hypercortisolism may occur .
CONTRA-INDICATION OF BETNOVATE N CREAM
BETNOVATE N is contraindicated in children under 2 years of age . Due to the known ototoxic and nephrotoxic potential of neomycin sulphate , the use of BETNOVATE N in large quantities or on large areas for prolonged periods of time is contraindicated in circumstances where significant systemic absorption may occur .
the following conditions should not be treated with BETNOVATE N : – rosacea – acne vulgaris – perioral dermatitis – pruritus without inflammation -perianal and genital pruritus – primary cutanneous viral infections – primary infected skin lesion caused by infection with fungi , or bacteria – primary or secondary infections due to yeasts – secondary infections due to pseudomonas or proteus species – otitis externa when the ear drum is perforated , because of the risk of ototoxicity .
STORAGE OF BETNOVATE N CREAM
store at temperature not exceeding 30 ° C .
PACK OF BETNOVATE N CREAM
BETNOVATE N CREAM is packed in a collapsible alluminium tube , internally coated with an epoxy resin based lacquer and closed with a cap .
BETNOVATE N CREAM MANUFACTURED BY
Smithkline Beecham – El -Giza-EGYPT For : Glaxosmithkline Egypt.
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