Properties
What is it?
International Nonproprietary Name - Ketoconazole, Zinc pyrithione Pharmacological group: Antifungal and other effects preparation Composition: Ketoconazole BF - 2% w/w Zinc pyrithione - 1% w/w Base - q.s. Indication: Axitop® is indicated for the treatment and prevention of seborrheic dermatitis, pityriasis capitis (dandruff), and pityriasis versicolor, which may be associated with the fungus - Pityrosporum. Contraindication: Hypersensitivity to ketoconazole or any of the excipients. Dosage and method of administration: Adults including elderly and adolescents: Wet hair and scalp thoroughly with water. Apply shampoo in an amount sufficient to produce enough lather to wash the hair and scalp, gently massage into the scalp and leave for 3-5 minutes, then rinse. Seborrheic dermatitis and dandruff: Use Axitop® twice a week for 2-4 weeks. Prevention: Use Axitop® once every 1-2 weeks. Pityriasis versicolor: Use Axitop® once daily for a maximum of 5 days. Prevention: As pityriasis pathways become more apparent with sun exposure, Axitop® may be used once daily for a maximum of 3 days during a treatment course prior to sun exposure. Side effects: The safety of Axitop® was evaluated in 2980 subjects participating in 22 clinical trials. Axitop® was used topically on the scalp and/or skin. Based on the summarized safety data from these clinical trials, no ≥1% ADRs were observed. The following table presents ADRs described during the use of Axitop® in clinical trials or post-marketing experience.