Sporaxol (itraconazole) capsules 100 mg. №10

Description

Sporaxol (itraconazole) capsules 100 mg. №10

Composition 

active substance: itraconazole;

1 capsule contains itraconazole 100 mg;

Excipients: spherical sugar (sucrose, corn starch, purified water), poloxamer 188, hypromellose 6 cP, poloxamer 188 micronized, capsule (indigo carmine) (E 132), quinoline yellow (E 104), titanium dioxide (E 171), purified water , gelatin).

Dosage form

Capsules.

Main physical and chemical properties: opaque hard gelatin capsules №0 with green lid and body, containing yellow-beige spherical microgranules.

Pharmacotherapeutic group

Antifungal drugs for systemic use. Itraconazole.
ATX code J02A C02.

Pharmacological properties

A synthetic antifungal drug intended for systemic use. The active agent of the drug is itraconazole.
The mechanism of action is due to its ability to inhibit the synthesis of ergosterol, which is an important component of the fungal cell membrane.

Indications

Sporaxol is prescribed for the treatment of mycoses caused by pathogens that are sensitive to this drug, including diseases such as:

• vulvovaginal candidomycosis;
• chronic recurrent fungal vulvovaginitis;
• mycoses of the skin, oral cavity, eyes, onychomycosis caused by dermatophytes or yeasts;
• aspergillosis of the lungs and extrapulmonary localization in patients suffering from intolerance or refraction to amphotericin B therapy;
• systemic mycoses, including systemic aspergillosis, candidiasis, cryptococcosis, including cryptococcal meningitis;
• histoplasmosis (including chronic pulmonary, disseminated, not meningeal), sporotrichosis, paracoccidioidosis, blastomycosis, as well as other systemic, including rare and tropical mycoses.

Trichophyton spp., Epidermophyton floccosum, Microsporum spp., Candida spp. Are sensitive to itraconazole. (including C. albicans), Cryptococcus noeformans, Sporothix schencki, Fonsecaea spp., Cladosporium spp., Blastomyces dermatidis, some other microorganisms.

Contraindications

Contraindicated in case of allergy to itraconazole, or other active ingredient of the drug.
It is contraindicated to use with CYP3A4 substrates, eletriptan, nizoldipine, simvastatin, lovastatin, triazolam, midazolam. Also, it should not be used in patients with ventricular dysfunction.
The encapsulated form is not recommended for children under 15 years of age.

Application during pregnancy and lactation

Application during pregnancy and lactation is possible only when the tangible positive effects for the body are higher than the likely harm caused.
Breastfeeding is stopped during treatment with itraconazole.

Method of administration and dosage

Sporaxol is taken immediately after meals, 1-2 times a day. The exact dosage and course of treatment is prescribed by the attending physician. Usually Sporaxol prescribed for treatment:

• vulvovaginal candidiasis – 1 day – 200 mg, 2 times a day or 3 days, 200 mg 1 time a day.
• chronic recurrent fungal vulvovaginitis – 100 mg 2 times a day (1 week), and during the next 3-6 menstrual cycles, take 100 mg on the first day of the cycle.
• lichen – 200 mg once a day (1 week);
• dermatomycosis – 100 mg once a day (15 days), with lesions of the skin of the hands or feet – additionally the same dose is taken for another 15 days;
• oral candidiasis – 100 mg, once a day (15 days);
• fungal keratitis – 200 mg, 1 time per day (3 weeks);
• onychomycosis – 200 mg once a day (3 months), with damage to the nails on the toes – 3 courses, taking 1 week and 3 weeks off, on the hands – 2 such courses;
• systemic candidiasis – 100-200 mg, 1 time per day (from 3 weeks to 7 months), the dose may be doubled;
• systemic cryptococcosis without meningitis – 200 mg once a day, with meningitis – 2 times a day.
• Maintenance therapy – once a day (2-12 months);
• histoplasmosis – 200 mg, 1-2 times a day, (6-8 months);
• sporotrichosis – 100 mg, once a day (6 months);
• chromomycosis – 100-200 mg, once a day (6 months);
• aspergillosis – 200 mg 1-2 times a day (2-5 months);
• blastomycosis – 100-200 mg 1-2 times a day (6 months).

With weakened immunity, dosages may be increased.

Overdose

To date, no cases of overdose have been recorded. If an overdose occurs, you should rinse the stomach, take sorbents.

Side effects

The most common side effects are:

• dyspepsia, nausea, constipation, hepatitis;
• headache, dizziness, peripheral neuropathy;
• allergic reactions such as pruritus, urticaria, angioedema;
• dysmenorrhea, hypokalemia (rarely).