Properties
What is it?
Composition: Ketoconazole-B.P 2% w/w, Cream Base–S.R. Indication: For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus, tinea pedis infections caused by Trichophyton spp., Microsporon spp., Epidermophyton spp. Axitop is also indicated for the treatment of cutaneous candidiasis (including vulvitis), tinea versicolor and seborrheic dermatitis caused by Malesseria (formerly Pityrosporum). Contraindication: Ketoconazole cream is contraindicated in patients who are hypersensitive to any of the ingredients or to ketoconazole itself. Dosage and Method of Administration: Ketoconazole cream is used in adults Tinea pedis: Axitop® cream is applied to the affected area twice daily. The usual duration of treatment for mild infections is 1 week. For more severe and extensive infections (including one or both feet), treatment should be continued for a few days after the disappearance of signs and symptoms to prevent recurrence. For other infections: Axitop cream should be applied to the affected areas daily, depending on the severity of the infection. Treatment should be continued for a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor–2-3 weeks, tinea corporis–3-4 weeks. If there is no clinical improvement after 4 weeks, the diagnosis should be reviewed. General hygiene measures should be taken in relation to the focus of infection to prevent recurrence of the infection. Seborrheic dermatitis This is a chronic disease and recurrence is highly likely. Method of application: For application to the skin. Pediatrics: Experience with the use of ketoconazole 2% cream in pediatric patients is limited. Warnings and Precautions: Ketoconazole cream is not intended for ophthalmic use. When used concurrently with a topical corticosteroid, to prevent withdrawal effects after prolonged use of corticosteroids, it is recommended to use a mild corticosteroid in the morning and apply Axitop in the evening, the topical corticosteroid should be gradually withdrawn over 2-3 weeks. The patient should avoid contact with the eyes. Side Effects: Common side effects of ketoconazole cream include: burning sensation of the skin, erythema at the application site, itching at the application site. If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. Overdose: Topical use: Topical overdose may cause erythema, edema, and burning sensation, which will disappear after discontinuation of treatment. Ingestion: In case of accidental ingestion, supportive and symptomatic measures should be taken. Dispensing Rule: Pharmaceutical product group II, dispensed with prescription form N3. Storage: Store in a dark and dry place, at a temperature below 25C, protected from direct light and out of reach of children.