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Beclomethasone Dipropionate, Ketoconazole and Neomycin Sulphate Cream is indicated for the relief of the inflammatory manifestations of corticosteroid responsive dermatoses when complicated by secondary infection caused by organisms sensitive to the components of this dermatologic preparation or when the possibility of such infection is suspected.
Such disorders include: Chronic dermatitis of the extremities, balanoposthitis, eczematoid dermatitis, contact dermatitis, follicular dermatitis, parakeratosis, paronychia, anal pruritus, intertrigo, impetigo, neurodermatitis, angular stomatitis, photosensitivity dermatitis, lichenified inguinal dermatophytosis and tinea infections such as tinea pedis, tinea cruris and tinea corporis.
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 the diagnosis may be necessary.
A small quantity of Beclomethasone Dipropionate, Ketoconazole and Neomycin Sulphate Cream should be applied to cover completely the affected area two or three times daily, or as prescribed by the physician. Frequency of application should be determined according to severity of the condition. Duration of therapy should be determined by patient response. In cases of tinea pedis, longer therapy (2 – 4 weeks) may be necessary.
The most frequent adverse reactions reported were burning, irritation, itching and stinging sensation. Less frequent adverse reactions were skin atrophy, cracking and fissuring of the skin, erythema, folliculitis, numbness of fingers, skin atrophy and telangiectasia.
The following additional local adverse reactions have been reported occasionally with topical corticosteroids: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have been reported with oral administration.
Beclomethasone Dipropionate, Ketoconazole and Neomycin Sulphate Cream 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. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Manifestations of Cushing syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.
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 Kozon Cream, treatment should be discontinued and appropriate therapy instituted.
Prolonged use of topical antibiotics occasionally may result in overgrowth of non-susceptible organisms. If this occurs or if irritation, sensitization or super infection develops, treatment with Kozon Cream should be discontinued and appropriate therapy instituted.
Store below 30 °C preferably in cool and dry place. Protect from light.
Keep the medicine out of reach of children.
Beclomethasone Dipropionate, Ketoconazole and Neomycin Sulphate Cream available in Lami tube with white cap containing 15 g of cream. Such 01 tube in a monocarton with pack insert.
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