País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
itraconazole
Janssen Cilag S.p.A.
J02AC02
itraconazole
100mg
capsules
(14/1x14/) in blister
Prescription
Registered
2019-10-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Orungal 100 mg Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains itraconazole 100 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsules, hard Capsule (Size 0): 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 _(Trichophyton spp._ , _Microsporum spp._ , _Epidermophyton floccosum_ ) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum. 4. Oropharyngeal candidosis. 5. Onychomycosis caused by dermatophytes and/or yeasts. 6. The treatment of histoplasmosis. 7. Orungal is indicated in the following systemic fungal conditions when first-line systemic anti- fungal therapy is inappropriate or has proved ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity. - Treatment of aspergillosis and candidosis - Treatment of cryptococcosis (including cryptococcal meningitis): in immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system. - Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection. Orungal is also indicated in the prevention of fungal infection during prolonged neutropenia when standard therapy is considered inappropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Orungal 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: _ _ _INDICATION_ _DOSE_ _REMARKS_ Vulvovaginal candidosis 200 mg twice daily for 1 day 1 Pityriasis versicolor 200 mg once daily for 7 days Tinea corporis, tinea cruris 100 mg once daily for 15 days or 200 mg once daily for 7 days Tinea pedis, tinea manuum 100 mg once daily for 30 days Oropharyngeal candidosis 100 mg once daily for Leer el documento completo