Vulvovaginal candidiasis; pityriasis versicolor; dermatomycosis caused by Itraconazole-sensitive pathogens (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), for example, dermatophytosis of the feet, inguinal dermatomycosis, dermatophytosis of the trunk, dermatophytosis of the hands; oropharyngeal candidiasis; onychomycosis caused by dermatophytes and / or yeast; histoplasmosis; systemic mycoses (in cases where first-line antifungal therapy cannot be used or in cases where treatment with other antifungal drugs is ineffective, which may be due to existing pathology, pathogen insensitivity, or drug toxicity): aspergillosis and candidiasis; cryptococcosis (including cryptococcal meningitis): treatment of immunosuppressed patients with cryptococcosis and all patients with Central nervous system cryptococcosis; supportive therapy in AIDS patients to prevent recurrence of existing fungal infection. Itraconazole should be prescribed for the prevention of fungal infection in patients with long-term neutropenia in cases where standard therapy is insufficient.
Eszol tablets Storage
active substance: itraconazole;
1 tablet contains itraconazole 100 mg;
Excipients: spherical sugar, hydroxypropylmethylcellulose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K 30, low-substituted hydroxypropylcellulose, sodium starch glycolate (type A), silicon dioxide hydroxide 39 talc, titanium dioxide (E 171), polyethylene glycols, lecithin, iron oxide red (E 172).
Eszol tablets Dosage form
Main physical and chemical properties: capsule-shaped tablets, coated with pink color, with the logo “ITR 100” on one side.
Antifungal drugs for systemic use. ATX code J02A CO2.
Eszol tablets Pharmacological properties
Itraconazole is a triazole derivative with a broad spectrum of action. In vitro studies have shown that itraconazole inhibits ergosterol synthesis in fungal cells. Ergosterol is an important component of the cell membrane of the fungus, inhibition of its synthesis provides an antifungal effect.
For itraconazole, limit values were set only for Candida spp. For superficial fungal infections (CLSI M27-A2 limit values were not set according to the EUCAST methodology). The CLSI limit values are as follows: sensitive ≤ 0.125, sensitive dose-dependent 0.25-0.5, resistant ≥ 1 μg / ml. Limit values have not been set for mycelial fungi.
In vitro studies have shown that itraconazole inhibits the growth of a wide range of fungi pathogenic to humans at concentrations typically ≤ 1 μg / ml. These include: dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), yeast (Candida spp., Including C. albicans, C. glabrata and C. krusei, Cryptococcus neoformans, Pityrosporum spp., Trichosporon spp., Geotrich. ,), Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatitidis, Coccidiodes immitis, Pseudallescheria boydii, Penicillium margin,
Candida krusei, Candida glabrata and Candida tropicalis are generally the least sensitive species of Candida, and some isolates show resistance to itraconazole in vitro.
The main types of fungi that are not inhibited by itraconazole are zygomycetes (Rhizopus spp., Rhizomucor spp., Mucor spp., And Absidia spp.), Fusarium spp., Scedosporium proliferans and Scopulariopsis spp.
dermatomycoses caused by itraconazole-sensitive pathogens (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), for example, foot dermatophytosis, inguinal dermatomycosis, trunk dermatophytosis, hand dermatophytosis;
onychomycosis caused by dermatophytes and / or yeast;
systemic mycoses (in cases where first-line antifungal therapy cannot be used or in case of ineffective treatment with other antifungal drugs, which may be due to existing pathology, insensitivity of the pathogen or toxicity of the drug):
aspergillosis and candidiasis;
cryptococcosis (including cryptococcal meningitis): treatment of immunocompromised patients with cryptococcosis and all patients with cryptococcosis of the central nervous system;
maintenance therapy in AIDS patients to prevent recurrence of existing fungal infections.
Itraconazole should be used to prevent fungal infections in patients with chronic neutropenia in cases where standard therapy is insufficient.
Itraconazole is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients.
Concomitant use of itraconazole and CYP3A4 substrates is contraindicated. Concomitant use may result in increased plasma concentrations of these drugs, which may lead to increased or prolonged therapeutic and adverse reactions and potentially life-threatening conditions. For example, increased concentrations of these drugs can lead to prolongation of the QT interval and ventricular tachyarrhythmias, including cases of ventricular fibrillation, arrhythmias with potentially fatal outcome. These drugs are listed in the section “Interaction with other medicinal products and other forms of interaction”.
Itraconazole is contraindicated in patients with ventricular dysfunction, such as congestive heart failure or a history of congestive heart failure, except for the treatment of life-threatening infections (see section 4.4).