País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ITRACONAZOLE
PCO Manufacturing
ITRACONAZOLE
100 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox 100mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains itraconazole 100 mg. Also contains sucrose. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard _Product imported from Greece:_ Gelatin capsule with opaque blue cap and pink transparent body containing coated beads. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Vulvovaginal candidosis 2. Pityriasis versicolor 3. Dermatophytoses caused by organisms susceptible to itraconazole 4. Oral candidosis 5. Fungal keratitis 6. Systemic mycoses 7. Onychomycosis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sporanox is for oral administration and must be taken immediately after a meal for maximal absorption. The capsules must be swallowed whole. Treatment schedules in adults for each indication are as follows: _Short-Term Usage_ INDICATION DOSE Vulvovaginal candidosis 200 mg twice daily for 1 day or 200 mg once daily for 3 days. Pityriasis versicolor 200 mg once daily for 7 days Tinea corporis, tinea cruris 100 mg once daily for 2 weeks or 200 mg once daily for 7 days Tinea pedis, tinea manuum 100 mg once daily for 4 weeks Oral candidosis 100 mg once daily for 2 weeks Fungal keratitis 200 mg once daily for 3 weeks IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/08/2011_ _CRN 2104693_ _page number: 1_ Treatment should not exceed four weeks _Long-term usage:_ Dosage recommendations vary according to the infection treated. Impaired absorption in AIDS and neutropenic patients may lead to low intraconazole blood levels and lack of efficacy. In such cases, blood level monitoring is indicated. _Use in children (below 12 years): Llegiu el document complet