Itracon capsules 100 mg. №15

Description

Itracon Storage
active substance: itraconazole;

1 capsule contains itraconazole, pellets in terms of itraconazole 100 mg;

excipients: hypromellose (hydroxypropylmethylcellulose (E 5)), sucrose;

gelatin capsule contains dyes: azorubin (E 122) and yellow FCF (E 110).

Itracon Dosage form
Capsules.

Main physical and chemical properties: hard gelatin capsules № 0 or № 1. The body of the capsule is pink, the lid is blue. Capsule content – granules from almost white to cream color, spherical shape.

Itracon Pharmacotherapeutic group
Antifungal drugs for systemic use.

ATX code J02A CO2.

Pharmacological properties

Pharmacodynamics

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. in 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 and resistant ≥1 μg / ml. Limit values ​​were not 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. tropicalis, C. parapsilosis and C. krusei, Cryptococcus neoformans, Malassezia spp., Trichosporon spp., Geotrichum spp.), Aspergillus spp .; Histoplasma spp., Including H. capsulatum; Paracoccidioides brasiliensis; Sporothrix schenckii; Fonsecaea spp .; Cladosporium spp .; Blastomyces dermatitidis; Coccidiodes immitis; Pseudallescheria boydii; Penicillium marneffei and other species of yeasts and fungi.

Indication
Vulvovaginal candidiasis;
herpes zoster;
dermatomycoses caused by itraconazole-sensitive pathogens (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), for example, foot dermatophytosis, inguinal dermatomycosis, trunk dermatophytosis, hand dermatophytosis;
oropharyngeal candidiasis;
onychomycosis caused by dermatophytes and / or yeast;
histoplasmosis;
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.
Itracon® is also indicated for the prevention of fungal infections in patients with chronic neutropenia in cases where standard therapy is insufficient.

Contraindication
Itracon® capsules are contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients.

Concomitant use of Itracon® 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 may 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”.

Itracon® capsules are 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).

Itracon® capsules should not be used during pregnancy, except in the treatment of life-threatening conditions of the mother (see section “Use during pregnancy or breast-feeding”).