Wednesday, 23 May 2012

Betnovate Cream





1. Name Of The Medicinal Product



Betnovate Cream


2. Qualitative And Quantitative Composition



Betamethasone Valerate BP 0.122% W/W



3. Pharmaceutical Form



Aqueous Cream



4. Clinical Particulars



4.1 Therapeutic Indications



Betamethasone valerate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and is often effective in the less responsive conditions such as psoriasis.



Betnovate preparations are indicated for the treatment of eczema in children and adults, including atopic and discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalised erythroderma.



4.2 Posology And Method Of Administration



A small quantity of Betnovate should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often, or by using the appropriate ready-diluted (1 in 4) preparation Betnovate R.D. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary.



Betnovate and Betnovate R.D. creams are especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so.



In the more recent resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betnovate 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.



Children



Courses should be limited to five days. Occlusion should not be used.



For topical administration.



4.3 Contraindications



Hypersensitivity to the active substance or any of the excipients in the product.



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 is contraindicated in dermatoses in infants under one year of age, including dermatitis



4.4 Special Warnings And Precautions For Use



Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing's syndrome, can occur even without occlusion. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see section 4.8 Undesirable Effects and Section 4.9 Overdose).



The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.



If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.



Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.



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 systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.



Further Information



The least potent corticosteroid which will control the disease should be selected. None of these preparations contain lanolin. Betnovate Cream and Ointment and the corresponding RD preparations do not contain parabens. Betnovate Lotion contains parabens.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.



4.7 Effects On Ability To Drive And Use Machines



There have been no studies to investigate the effect of betamethasone valerate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical betamethasone valerate.



4.8 Undesirable Effects



Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (














Immune system disorders


 


Very rare:




Hypersensitivity.




If signs of hypersensitivity appear, application should stop immediately.


 


Endocrine disorders


 


Very rare:




Features of Cushing's syndrome



As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce suppression of the HPA axis and the clinical features of Cushing's syndrome (see Section 4.4 Special Warnings and Precautions for use). These effects are more likely to occur in infants and children, and if occlusive dressings are used. In infants the napkin may act as an occlusive dressing.










Skin and subcutaneous tissue disorders


 


Common:




Local skin burning and pruritus.




Very rare:




Local atrophic changes in the skin such as thinning, striae and dilatation of the superficial blood vessels may be caused by prolonged and intensive treatment with highly active corticosteroid preparations, particularly when occlusive dressings are used or when skin folds are involved.



Pigmentation changes, hypertrichosis, allergic contact dermatitis, exacerbation of symptoms, pustular psoriasis (due to treatment of psoriasis with corticosteroids or its withdrawal: see Section 4.4. Special Warnings and Precautions for use)



4.9 Overdose



Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing's syndrome may appear and in this situation topical steroids should be discontinued gradually under medical supervision (see Section 4.4 Special Warnings and Precautions for use).



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Betamethasone valerate is an active corticosteroid with topical anti-inflammatory activity.



5.2 Pharmacokinetic Properties



Absorption



Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.



Distribution



The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary because circulating levels are well below the level of detection.



Metabolism



Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver.



Elimination



Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.



5.3 Preclinical Safety Data



Reproductive toxicity



Subcutaneous administration of betamethasone valerate to mice or rats at doses



The effect on fertility of betamethasone valerate has not been evaluated in animals.



6. Pharmaceutical Particulars



6.1 List Of Excipients






















Chlorocresol




BP




Cetomacrogol 1000




BP




Cetostearyl Alcohol




BP




White Soft Paraffin




BP




Liquid Paraffin




BP




Sodium Acid Phosphate




BP




Phosphoric Acid




BP




Sodium Hydroxide




BP




Purified Water




BP



6.2 Incompatibilities



None known.



6.3 Shelf Life








Tubes




36 Months




500gm pots




18 months



6.4 Special Precautions For Storage



Store below 25°C.



6.5 Nature And Contents Of Container



15gm, 30gm and 100gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a cap.



500mg opaque high density polythene pots with black urea formaldehyde screw caps having a steran faced wad.



Not all pack sizes may be marketed



6.6 Special Precautions For Disposal And Other Handling



No special instructions.



Administrative Data


7. Marketing Authorisation Holder



Glaxo Wellcome UK Ltd.,



T/A GlaxoSmithKline UK



Stockley Park West,



Uxbridge,



Middlesex UB11 1BT



8. Marketing Authorisation Number(S)



PL10949/0014



9. Date Of First Authorisation/Renewal Of The Authorisation



24 October 1997



10. Date Of Revision Of The Text



1 February 2012




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