Topiclo®S Ointment: Each gram ointment contains Clobetasol Propionate USP 0.50 mg & Salicylic Acid BP 30 mg.
Topiclo® S ointment contains the active compound Clobetasol Propionate, a synthetic corticosteroid and Salicylic Acid, a keratolytic agent, for topical dermatologic use. Clobetasol is an analog of prednisolone having a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Salicylic Acid is a keratolytic and antiseptic agent.
Apply a thin layer of Topiclo® S ointment to the affected skin areas twice daily and rub in gently and completely. For some patients, adequate maintenance therapy may be achieved with less frequent application.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
It should not be used with occlusive dressings.
Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients. Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be máde to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The ointment should not be used on the face, groin or axillae.This ointment is not for ophthalmic use. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing syndrome, hyperglycemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA suppréssion. Clobetasol produced HPA axis suppression when used at doses as low as 2 g/day for 1 week in patients with eczema. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios."If irritation or sensitization develops with the use of this ointment, treatmént should be discontinued and appropriate therapy instituted. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of the ointment should be discontinued until the infection has been adequately controlled.
Do not store above 30°C temperature. Keep away from light and wet place. Keep out of reach of children. Do not store at refrigerate.