Properties
What is it?
Axytopi® Cream (Ketoconazole Cream B.P) Composition: Ketoconazole - B.P 2% w/w Cream base – S.R. Pharmacodynamics: ATC Code: D01AC08 See Blog: Axytopi - A remedy for skin-related medical conditions Axytopi® usually acts quickly on itching, which is often observed in dermatophyte and yeast-induced infections, as well as skin infections associated with Malassezia spp. Symptomatic improvement is observed before the first signs of recovery. Ketoconazole, a synthetic derivative of imidazole dioxylene, has potent antifungal activity against dermatophytes such as Trichophyton spp., Epidermophyton flucostem, Microsporum spp., and yeasts, including Malassezia spp. and Candida spp. Its effect on Malassezia spp. is practically definitive. A study of 250 patients, applying ketoconazole 2% cream and clotrimazole 1% cream twice daily for 7 days on both feet, showed efficacy in patients with tinea pedis (athlete's foot) and interdigital lesions. The primary efficacy endpoint was a negative microscopic KOH examination after 4 weeks. Treatment with 2% ketoconazole showed similar results to the use of 1% clotrimazole for 4 weeks. No signs of relapse were observed 8 weeks after treatment with ketoconazole cream. Pharmacokinetics: Plasma concentrations of ketoconazole were not detectable after topical application of ketoconazole cream in adults. In one study of infants with seborrheic dermatitis (n=19), where approximately 40 mg of ketoconazole cream was applied daily to 40% of the body surface, ketoconazole levels in plasma were detectable in 5 infants, ranging from 32 to 133 ng/mL. Indications: For topical use 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. Axytopi® is also indicated for the treatment of cutaneous candidiasis (including vulvitis), tinea (pityriasis) versicolor, and seborrheic dermatitis caused by Malessezia (formerly Pityrosporum) spp. Dosage and Method of Administration: Ketoconazole cream is used in adults. Tinea pedis: Axytopi® cream should be applied to the affected area twice daily. The usual duration of treatment for mild infections is 1 week. For more severe and widespread infections (including one or both feet), treatment should be continued for a few days after the disappearance of signs and symptoms to rule out relapses. For other infections: Axytopi® 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. Seborrheic dermatitis is a chronic condition and relapse is highly likely. Method of application: For topical application to the skin. Pediatrics: Experience with the use of ketoconazole 2% cream in pediatric patients is limited. Contraindications: Ketoconazole cream is contraindicated in patients who are hypersensitive to any of the ingredients or to ketoconazole itself. Warnings and Precautions: Ketoconazole cream is not intended for ophthalmic use. When used concurrently with a topical corticosteroid, to prevent the rebound effect after discontinuation of long-term treatment with topical corticosteroids, it is recommended to continue using a mild topical corticosteroid in the morning and Axytopi® in the evening, and to gradually withdraw the topical corticosteroid treatment over 2-3 weeks. Side Effects: Common side effects of ketoconazole cream include: burning sensation of the skin, erythema at the application site, and itching at the application site. Overdosage: Topical use: Excessive topical application may cause erythema, swelling, and a burning sensation, which will disappear after discontinuation of treatment. Ingestion (swallowing): Supportive and symptomatic measures should be taken in case of accidental ingestion. Storage: Store in a dark and dry place, at a temperature below 25°C. Keep away from direct light. Avoid contact with eyes. Dispensing Rule: Pharmaceutical product group II, dispensed with prescription form №3.
