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Dermovate

Dermovate

clobetasol

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Clobetasol propionate
Indications/Uses
Relief of inflammatory & pruritic manifestations of steroid responsive dermatoses including psoriasis (excluding widespread plaque psoriasis), recalcitrant dermatoses, lichen planus, discoid lupus erythematosus, other skin conditions which do not respond satisfactorily to less potent steroids, for adults, elderly & childn >1 yr.
Dosage/Direction for Use
Apply thinly & gently rub in the affected area once daily or bid for up to 4 wk until improvement occurs. Max: 50 g/wk.
Contraindications
Untreated cutaneous infections, rosacea, acne vulgaris, pruritus w/o inflammation, perianal & genital pruritus, perioral dermatitis. Dermatoses in childn <1 yr, including dermatitis.
Special Precautions
Patients w/ history of local hypersensitivity to corticosteroids. W/draw drug gradually if manifestations of hypercortisolism (Cushing's syndrome) & reversible hypothalamic-pituitary-adrenal axis suppression, leading to glucocorticosteroid insufficiency, are observed. Abrupt w/drawal of treatment may result in glucocorticosteroid insufficiency. Risk factors for increased systemic effects are potency & formulation of topical steroid; duration of exposure; application to large surface area; use on occluded areas of skin eg, on intertriginous areas or under occlusive dressings (in infants the nappy may act as occlusive dressing); increasing hydration of stratum corneum; use on thin skin areas eg, face; & on broken skin or other conditions where skin barrier may be impaired. Infection risk w/ occlusion. Ensure careful patient supervision if used in psoriasis. Use appropriate antimicrobial therapy in case of infection. Any spread of infection requires w/drawal of topical corticosteroid therapy & administration of appropriate antimicrobial therapy. Higher occurrence of local hypersensitivity reactions & increased risk of local infection if used in dermatitis around chronic leg ulcers. Limit treatment to only a few days if used on the face. Ensure prep does not enter the eye if applied to eyelids, as cataract & glaucoma might result from repeated exposure. Reports of visual disturbance. Contains paraffin; instruct patients not to smoke or go near naked flames due to risk of severe burns. Min quantity should be used for the shortest duration to achieve desired clinical benefit in patients w/ renal/hepatic impairment. Pregnancy & lactation. Adrenal suppression in childn <12 yr may occur on long-term use. Increased susceptibility to atrophic changes w/ use in childn; limit treatment to only a few days & review wkly.
Adverse Reactions
Drug Interactions
Increased systemic exposure w/ CYP3A4 inhibitors (eg, ritonavir & itraconazole).
MIMS Class
Topical Corticosteroids
ATC Classification
D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Form
Dermovate cream 500 mcg/g
Packing/Price
5 g x 1's
Form
Dermovate oint 500 mcg/g
Packing/Price
5 g x 1's
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