= Additional active ingredients
Hydrocortisone acetate 1%, pramoxine HCl 1%.
PRESENTATION AND DOSSAGE
NO INTERACTION WITH FOOD
Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Hypersensitivity to any of the components.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients.Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.In pediatric patients absorption may result in higher blood levels and thus more susceptibility to systemic toxicity. See prescribing information for full details. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. See prescribing information for full details.
MANUFACTURER & DISTRIBUTER:
Manufacturer: Meda Pharmaceuticals
License Holder: Megapharm Ltd.