Composition Each gram contains: Ketoconazole (INN)………………. 20 mg Excipients: propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, polysorbate 80, isopropyl myristate, sodium bisulfite and purified water, q.s. Properties Ketoisdin (ketoconazole) cream has a potent action against dermatophytes such as Trichophyton rubrum, T. mentagrophytes and T. tonsurans, Epidermophyton floccosum and Microsporum canis, against yeasts such as Candida albicans and C. tropicales and against Pityrosporum orbiculare and P. ovale. In general, Ketoisdin (ketoconazole) cream rapidly reduces itching caused by dermatophyte or yeast infections. This symptomatic improvement occurs before the first signs of healing are detected, after just a few days of treatment. Plasma concentrations of ketoconazole are not detectable after topical application. Indications Ketoisdin (ketoconazole) cream is indicated for the topical treatment of dermatophyte infections of the skin: tinea corporis, tinea cruris, tinea manuum and tinea pedis caused by Trichophyton spp., Microsporum spp. and Epidermophyton spp., and for the treatment of cutaneous candidiasis and pityriasis versicolor. Ketoisdin (ketoconazole) cream is also indicated for the treatment of seborrhoeic dermatitis caused by Pityrosporum ovale.
Posology Ketoisdin (ketoconazole) cream should be applied once daily (preferably at night) to areas affected by tinea corporis, tinea curis, tinea manuum, tinea pedis, cutaneous candidiasis, seborrhoeic dermatitis and pityriasis versicolor. Treatment should be continued for sufficient time or until at least a few days after all symptoms have disappeared. In severe cases and at the doctor’s discretion, this dose may be increased to up to twice daily (morning and night). If no clinical improvement is observed after 4 weeks of treatment, the diagnosis should be reconsidered. General hygiene measures should be observed to control sources of infection or reinfection. The usual duration of treatment is: pityriasis versicolor 2-3 weeks, seborrhoeic dermatitis 2-4 weeks, yeast infections 2-3 weeks, tinea cruris 2-4 weeks, tinea corporis 3-4 weeks and tinea pedis 4-6 weeks. If a topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using Ketoisdin (ketoconazole) cream in order to reduce the incidence of steroid-induced skin sensitisation which has been reported when no recovery period has been allowed. Contraindications Ketoisdin (ketoconazole) cream should not be administered to patients with a hypersensitivity to any of its components. Given that plasma concentrations of ketoconazole are not detectable after topical application, its use during pregnancy and lactation is not contraindicated. However, potential risks should be assessed prior to use. Precautions Ketoisdin (ketoconazole) cream should not be used for ophthalmic treatments. Excipients warnings This medicinal product contains sodium bisulfite as an excipient and may therefore cause allergic reactions, including anaphylactic reactions and bronchospasm, in susceptible patients, especially in those with a history of asthma or allergies. Interactions No interactions have been reported. Undesirable effects In some cases, irritation, dermatitis or a burning sensation may occur during treatment. Poisoning and its treatment Due to its pharmaceutical form and method of administration, poisoning is highly unlikely. However, in the case of accidental ingestion, appropriate symptomatic therapy should be administered. Contact the Toxicological Information Service on 91 562 04 20 Pack sizes Cream: Tube containing 30 g. Subject to medical prescription KEEP MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN Manufactured by: Laboratorios Dr. Esteve, S.A Isdin SA Provençals, 33 08019 Barcelona Spain Detailed information on this medicine is available on the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices - AEMPS) web site: http://www.aemps.es/
August, 15, 2008 Lawsuits help guarantee drug safety, doctors say By Ricardo Alonso-Zaldivar, Associated Press Writer Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug safety, the editors of the New England J
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