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  • Daktacort
    / Janssen


    Active Ingredient *
    Hydrocortisone 10 mg/g
    Miconazole (nitrate) 20 mg/g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cream

    15 g

    full basket chart 582 4001

    Dosage

    The product should be applied topically to the lesion once to twice daily. It should be rubbed in gently until it has been completely penetrated into the skin. The treatment with the product (or subsequently with miconazole nitrate 20 mg/g topical cream) should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks).
    Pediatrics: In infants and children, caution is advised when the product is applied to extensive surface areas or under occlusive dressings including baby napkins (diapers). In infants, long term continuous topical corticosteroid therapy should be avoided.
    Eldery: Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.


    Indications

    Infections of the skin caused by dermatophytes or candida species in which inflammatory symptoms are prominent.


    Contra-Indications

    Known hypersensitivity to miconazole or other imidazole derivatives, hydrocortisone or another ingredient of the drug. Tuberculous skin infections, herpes simplex, vaccinia, all forms of varicella.  


    Special Precautions

    If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued. This product must not come into contact with the mucosa of the eyes. As with any topical corticosteroid, caution is advised with infants and children when this product is to be applied to extensive surface areas or under occlusive dressings including baby napkins (diapers). Similarly application to the face should be avoided. In infants, long-term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion. Because of its corticosteroid content avoid long-term treatment with this product. Once the inflammatory symptoms have disappeared treatment may be continued with miconazole nitrate 20mg/g cream. This product can damage certain synthetic materials. Therefore, it is recommended to wear cotton underwear if this clothing comes into contact with the affected area. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole topical formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.


    Side Effects

    Skin irritation, skin burning sensation, irritability.
    See prescribing information for full details.


    Drug interactions

    Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and the anticoagulant effect should be monitored. The effects and side effects of some other drugs (e.g., certain oral hypoglycemics and phenytoin), when co-administered with miconazole, can be increased and caution should be exercised. Miconazole is a CYP3A4 inhibitor that can decrease the rate of metabolism of hydrocortisone. Serum concentrations of hydrocortisone may be higher with the use of this product compared with topical preparations containing hydrocortisone alone.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Caution is recommended during pregnancy. Treatment of large surfaces and the application under occlusive dressing should be avoided during that time.
    Lactation: There are no adequate studies. Caution is recommended during breast-feeding. Treatment of large surfaces and the application under occlusive dressing should be avoided during that time.
    See prescribing information for full details.


    Overdose

    Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Topically applied, corticosteroids can be absorbed in sufficient amounts to produce systemic effects.


    Important notes

    After first opening, use within 3 months.
    Contact should be avoided between latex products such as contraceptive diaphragms or condoms and this product since the constituents of it may damage the latex.


    Manufacturer
    Janssen Pharmaceutica, Beerse, Belgium
    Licence holder
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