Each 15 g contains: Ketoconazole BP 2% w/v, Cream base Q.S.
Pharmacology: Pharmacokinetics: The absorption of Ketoconazole from the gastrointestinal tract is variable and increases with decreasing stomach pH. Mean peak plasma concentrations of about 3.5 micrograms/mL have been obtained 2 hours after administration of 200 mg by mouth. Systemic absorption after topical or vaginal application in healthy subjects is minimal. Ketoconazole is more than 90% bound to plasma proteins, mainly albumin. It is widely distributed and appears in breast milk. Penetration into the CSF is poor. The elimination of Ketoconazole is reported to be biphasic, with an initial half life of 2 hours and a terminal half-life of about 8 hours. Ketoconazole is metabolised in the liver to inactive metabolites. It is excreted in the urine.
For the treatment of dermatophyte infections of the skin, Tinea corporis, Tinea cruris, Tinea manus, and Tinea pedis due to Trichophyton rubrum, as well as in the treatment of cutaneous candidiasis and Tinea (pityriasis) versicolor.
Ketoconazole should be applied to affected areas once daily. Treatment should be continued for a sufficient period, at least until a few days after disappearance of all symptoms. The diagnosis and/or treatment should be reconsidered if no clinical improvement is noted after 4 weeks of therapy. General measures in regard to hygiene should be observed to control sources of infection or re-infection. The usual duration of treatment is: Tinea versicolor (2-3 weeks), yeast infections (2-3 weeks), Tinea cruris (2-4 weeks), Tinea corporis (3-4 weeks), Tinea pedis (4-6 weeks).
Ketoconazole is contraindicated in individuals who have shown hypersensitivity to any of the ingredients.
Irritation may occur when Ketoconazole is used immediately after prolonged treatment with topical corticosteroids. Therefore, to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids, it is recommended to continue applying a mild topical corticosteroid in the morning and apply Ketoconazole in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
Pruritus, irritation, and burning sensation have been reported during treatment with ketoconazole. Also, in rare circumstances, allergic local skin phenomena, such as contact dermatitis, have been associated with Ketoconazole cream or one of its components, namely sodium sulphite or propylene glycol.
Store at temperatures not exceeding 30°C.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Topical cream 2% x 15 g x 1's.