Funit capsules 100 mg. №30

Description

Funit Storage
active substance: itraconazole;

1 capsule contains itraconazole 100 mg;

excipients: hydroxypropylmethylcellulose, polyethylene glycol 6000;

neutral micropellets: spherical sugar, corn starch;

gelatin capsule: azorubin (E 122), patented blue V (E 131), titanium dioxide (E 171), caramel (E 150), gelatin.

Funit Dosage form
Capsules.

Main physical and chemical properties: hard gelatin capsules with a pink lid and a brown body, containing spherical micropellets from white to almost white.

Funit Pharmacotherapeutic group
Antifungal agents for systemic use. Triazole derivatives.

ATX code J02A C02.

Pharmacological properties

Pharmacodynamics.

Itraconazole is a triazole derivative with a broad spectrum of action.

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 ​​are set only for Candida spp. For superficial fungal infections (CLSI M27-A2, limit values ​​are not set according to the EUCAST methodology). 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.

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, pathogen insensitivity or drug toxicity):
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.
Funit® can also be used to prevent fungal infections in patients with chronic neutropenia in cases where standard therapy is insufficient.

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

Concomitant use of Funit® 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”.

Funit® 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).

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