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Clovate

Clovate

clobetasol

Manufacturer:

Rainbow Life Sciences

Distributor:

Ambica
Concise Prescribing Info
Contents
Clobetasol propionate
Indications/Uses
Short-term treatment of steroid responsive dermatoses resistant to other less potent topical corticosteroids such as: Cream: Psoriasis (excluding widespread plaque psoriasis); recalcitrant dermatoses, lichen planus, discoid lupus erythematosus, other skin conditions which do not respond satisfactorily to less potent steroids. Oint: Contact & atopic dermatitis, eczema, lichen planus, bug bites, psoriasis & alopecia areata.
Dosage/Direction for Use
Cream Apply thinly & gently rub to the affected area once daily or bid, in a sufficient quantity covering interested zone, & allow adequate time for absorption after each application until improvement occurs. Oint Apply sparingly to the affected area once daily or bid, in a sufficient quantity covering interested zone, & massage until complete absorption, continuing until improvement occurs.
Contraindications
Hypersensitivity. Cream: Untreated cutaneous infections, rosacea, acne vulgaris, pruritus w/o inflammation, perianal & genital pruritus, perioral dermatitis. Dermatoses in childn <1 yr, including dermatitis & nappy eruptions.
Special Precautions
Occlusive dressings may induce bacterial infections. Cleanse skin before applying fresh dressing when using occlusive dressings. Pregnancy & lactation. Avoid long-term continuous therapy particularly in infants & childn <12 yr as adrenal suppression can occur even w/o occlusion. Cream: Reported cases of osteonecrosis serious infections (including necrotizing fasciitis) & systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) w/ long-term use beyond recommended doses. Consider less potent corticosteroid prep if treatment w/ local corticosteroids is clinically justified >4 wk. Patients w/ history of local hypersensitivity to other corticosteroids. W/draw drug gradually by reducing frequency of application, or by substituting less potent corticosteroid if manifestations of hypercortisolism (Cushing's syndrome) & reversible hypothalamic-pituitary-adrenal axis suppression, leading to glucocorticosteroid insufficiency, in some individuals as result of increased systemic absorption of topical steroids 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; psoriasis; concomitant infection. Any spread of infection requires w/drawal of topical corticosteroid therapy & administration of appropriate antimicrobial therapy. Chronic leg ulcers. Limit treatment to 5 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. Visual disturbance. Consider ophth evaluation if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Contains paraffin; instruct patients not to smoke or go near naked flames due to risk of severe burns. Topical steroid w/drawal syndrome. More susceptible to develop atrophic changes w/ use in childn. Limit courses if possible to 5 days & review wkly, & do not use occlusion in childn & infants.
Adverse Reactions
Cream: Pruritus, local skin burning/skin pain. Oint: Stop application immediately if signs of hypersensitivity appear.
Drug Interactions
Inhibited metabolism of corticosteroids leading to 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
Clovate cream 0.5 mg/g (0.05% w/w)
Packing/Price
15 g x 1's
Form
Clovate oint 500 mcg/g (0.05% w/w)
Packing/Price
15 g x 1's
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