RUMYCOZ CAPSULES 100MG

Active ingredient and dosage form

capsules white or two-color (with a white case and a beige-brown lid), №0; the contents of the capsules are spherical microgranules from light yellow to yellowish-beige.
1 capsule contains 100 mg of itraconazole;
6 or 15 capsules per pack.

Mechanism of action

Rumicosis - antifungal medication. Itraconazole is a broad-spectrum synthetic antifungal agent derived from triazole. Inhibits the synthesis of ergosterol in the cell membrane of fungi, which causes the antifungal effect of the drug.
Itraconazole active against infections caused by dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), yeast-like fungi, and yeast (Cryptococcus neoformans, Pityrosporum spp., Candida spp. / including Candida albicans, Candida glabrata, Candida kappas, Candida klippraum spp., Candida albicans, Candida vebra, Candida klippanum spp., Candida sic., including Candida albicans, Candida vebra, Candida krucceum spp. spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatidis, as well as other yeast and mold fungi.

Indications and usage

Rumicosis indicated for the treatment of the following diseases:

• ringworm;
• fungal keratitis;
• onychomycosis caused by dermatophytes and / or yeasts and molds;
• Systemic mycoses: systemic aspergillosis and candidiasis, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and other systemic or tropical mycoses;
• Candidomycosis with damage to the skin or mucous membranes (including vulvovaginal candidiasis);
• deep visceral candidiasis;
• pityriasis versicolor.

Dosage and administration

Rumicosis capsules must be taken immediately after a meal. Capsules should be swallowed whole.

The oral bioavailability of itraconazole may be reduced in some immunocompromised patients, for example, in patients with neutropenia, AIDS patients or transplanted organs. Therefore, a double dose increase may be required.

Pulse therapy
One course of pulse therapy consists in daily intake of Rumikoza on 2 caps. 2 times / day (200 mg 2 times / day) for 1 week.
For the treatment of fungal infections of the nail plate brushes 2 courses are recommended.
For the treatment of fungal infections of the nail plate foot, 3 courses are recommended. The interval between courses, during which you do not need to take the drug, is 3 weeks.
Clinical results will become apparent after the end of treatment, as nails grow back.

Continuous therapy
On 2 caps. 1 time / day (200 mg 1 time / day) for 3 months.
Removal of Rumikoza from the skin and nail tissue is slower than from plasma. Thus, optimal clinical and mycological effects are achieved 2-4 weeks after the end of treatment for skin infections and 6-9 months after the end of the treatment of nail infections.
Systemic mycoses
Recommended doses vary depending on the type of infection.

Adverse reactions

Most frequently reported reactions in connection with the use of itraconazole were reactions from the gastrointestinal tract, such as: dyspepsia, nausea, abdominal pain and constipation.
In addition, it was noted: anorexia, headache, fatigue, reversible increase in liver enzymes, cholestatic jaundice, hepatitis, menstrual disorders, dizziness, allergic reactions (such as itching, rash, urticaria, angioedema), peripheral neuropathy, Stevens-Johnson syndrome, alopecia, alopecia, alopecia, allope, swelling, edema, congestive heart failure and pulmonary edema, dark-colored urine staining, hypercreatininemia.
In very rare cases when itraconazole was applied, severe toxic liver damage developed, incl. cases of acute liver failure with a fatal outcome.

Contraindications

- Rumycoz in capsules is contraindicated in patients with individual hypersensitivity to the drug or its constituent parts;
- pregnant women Rumycoz should be prescribed only if the expected benefit to the woman outweighs the potential risk to the fetus. Women of childbearing age who take Rumycoz need to use adequate methods of contraception throughout the course of treatment until the first menstruation after its completion;
- with caution - children's age; severe heart failure; liver diseases (including those accompanied by liver failure);
- terfenadine, astemizole, mizolastine, cisapride, dofetilide, quinidine, pimozide metabolized with isoenzyme CYP3A4, HMG-CoA reductase inhibitors such as Simvastatin and lovastatin, triazolam, and midazolam, should not be taken simultaneously with Rumikozom.

Pregnancy and lactation
Based on the results of preclinical studies and due to the fact that studies on the use of itraconazole in pregnant women have not been conducted, itrakanozol should be prescribed to pregnant women only with life-threatening systemic mycosis, when the potential benefit of therapy for a woman justifies the possible risk to the fetus.
Since a small amount of itraconazole is excreted in breast milk, the expected benefits of taking itraconazole must be compared with the risk for the baby when breastfeeding. In case of doubt, breastfeeding should not be.

List B. The drug should be stored in a dry, dark place and out of reach of children at a temperature not exceeding 25 ° C.
Shelf life - 2 years.
Pharmacy sales terms
The drug is available on prescription.

Rumicosis