Rumikoz - instructions for use, reviews, analogs and forms of release (capsules or tablets 100 mg) of the drug for treatment of thrush or candidiasis, nail fungus and other mycoses in adults, children and pregnancy. Composition and alcohol

In this article, you can read the instructions for using the drug Rumikoz. Comments of visitors of the site - consumers of this medication, as well as opinions of specialists on the use of Rumikoz in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Rumikoza in the presence of existing structural analogues. Use to treat thrush or candidiasis,fungus nails and other mycoses in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Rumikoz - a synthetic antifungal agent of a broad spectrum of action, a derivative of triazole. Inhibits the synthesis of ergosterol cell membrane of fungi, which determines the antifungal effect of the drug.

Itraconazole is active against dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), yeast-like fungi and yeast (Cryptococcus neoformans, Pityrosporum spp., Trichosporon spp., Geotrichum spp., Candida spp.), Including Candida albicans, Candida glabrata, Candida krusei), Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatidis, Pseudallescheria boydii, Penicillium marneffei, and also against yeasts and other fungi.

Composition

Itraconazole + excipients.

Pharmacokinetics

When administered orally, the maximum bioavailability of Itraconazole is noted when taking capsules immediately after meals. Binding to plasma proteins is 99.8% with plasma proteins. Itraconazole penetrates well and is distributed in tissues and organs. The concentration of the drug in the lungs, kidneys, liver, bones, stomach, spleen, skeletal muscles is 2-3 times higher than its concentration in the plasma. Accumulation of itraconazole in keratin tissues, especially in the skin, is 4 times higher than its accumulation in plasma, and the rate of excretion depends on the regeneration of the epidermis.

Unlike plasma concentrations that are not detectable within 7 days after cessation of therapy, therapeutic concentrations in the skin persist for 2-4 weeks after the cessation of the 4-week course of treatment; in the mucous membrane of the vagina - within 2 days after the end of the 3-day course of treatment with the drug at a dose of 200 mg per day and 3 days after the end of the 1-day course of treatment with the drug at a dose of 200 mg twice a day. The therapeutic concentration in the nail keratin is determined 1 week after the start of treatment and is maintained for 6 months after the completion of the 3-month course of therapy. Itraconazole is also defined in the secretion of the sebaceous and sweat glands.

Metabolised in the liver with the formation of active metabolites, one of which - hydroxy-itraconazole has an antifungal action comparable to itraconazole. Excretion with feces is from 3% to 18% of the dose. Excretion in the urine is less than 0.03%. Approximately 35% of the dose is excreted in the form of metabolites with urine for 1 week.

Indications

• dermatomycosis;
• fungal keratitis;
• onychomycosis caused by dermatophytes and / or yeast and mold fungi;
• systemic mycoses: systemic aspergillosis and candidiasis (thrush); cryptococcosis, including cryptococcal meningitis (for patients with immunodeficiency and for patients with cryptococcosis of the central nervous system, rheumycosis should be prescribed only if the first-line drugs are not applicable or effective in this case); histoplasmosis; sporotrichosis; paracoccidioidomycosis; blastomycosis; other systemic or tropical mycoses;
• Candidiasis with a lesion of the skin or mucous membranes (including vulvovaginal candidiasis);
• deep visceral candidiasis;
• pityriasis lichen.

Forms of release

Capsules 100 mg (sometimes mistakenly called pills).

There are no other medicinal forms, be it cream, ointment or candles.

Instructions for use and reception scheme

The drug is administered orally after a meal.

The bioavailability of itraconazole for oral administration may be reduced in some patients with impaired immunity, for example, in patients with neutropenia, AIDS patients or organ transplant patients. In such cases, a double dose increase may be required.

Pulse therapy

One course of pulse therapy is a daily intake of Rumikoza 200 mg twice a day (2 capsules 2 times a day) for 1 week.

For treatment of fungal lesions of the nail plates of the brushes, 2 courses are recommended.

For treatment of fungal lesions of the nail plates of the feet, 3 courses are recommended.

The interval between the courses, during which you do not need to take the drug, is 3 weeks. Clinical results become evident after the end of treatment, as the nails grow.

Continuous therapy

If the nail plates are injured with a lesion or without affecting the nail plates of the brushes, the dose is 200 mg per day, the duration of treatment is 3 months.

Removal of Rumikoz from the skin and nail tissue is slower than from the plasma. Thus, optimal clinical and mycological effects are achieved in 2-4 weeks after the end of treatment for skin lesions and 6-9 months after the end of treatment of nail diseases.

Side effect

• dyspepsia;
• nausea, vomiting;
• decreased appetite;
• abdominal pain;
• diarrhea;
• constipation;
• reversible increase in hepatic enzyme activity;
• hepatitis;
• severe toxic liver damage, incl. cases of acute hepatic insufficiency with a lethal outcome;
• headache;
• dizziness;
• peripheral neuropathy;
• skin rash;
• itching;
• hives;
• angioedema;
• multi-form exudative erythema (Stevens-Johnson syndrome);
• alopecia;
• photosensitization;
• menstrual cycle disorders;
• hypokalemia;
• edematous syndrome;
• congestive heart failure;
• pulmonary edema;
• staining the urine in a dark color;
• hypercreatininaemia.

Contraindications

• simultaneous with Rumikoz use of drugs metabolized with the participation of the isoenzyme CYP3A4, which are able to increase the QT interval (terfenadine, astemizole, misolastine, cisapride, dofetilide, quinidine, pimozide, levomethadone, sertindole); HMG-CoA reductase inhibitors metabolized with the participation of the CYP3A4 isoenzyme (simvastatin, lovastatin); midazolam and triazolam (for oral administration); preparations of ergot alkaloids (dihydroergotamine, ergometrine, ergotamine and methylergometrine);
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

In pregnancy, the drug should be prescribed only if the potential benefit of therapy for the mother exceeds the potential risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Women of childbearing age who take itraconazole should use adequate contraceptive methods throughout the course of treatment until the onset of the first menstruation after it is completed.

Use in children

Rumikoz should not be given to children, unless the expected benefit of therapy exceeds the possible risk.

special instructions

When examining the intravenous dosage form of itraconazole, there was a transient asymptomatic decrease in the left ventricular ejection fraction normalized until the next infusion of the drug.

Itraconazole has been found to have a negative inotropic effect. There have been reports of cases of heart failure associated with taking Rumikoza. Therefore, the drug is not prescribed for patients with chronic heart failure or having a history of this disease, unless the expected benefit of therapy significantly exceeds the potential risk.

In connection with the above, simultaneous use of the drug Rumikoz with alcohol is prohibited due to the development of potentially dangerous complications of cardiovascular diseases and conditions caused by joint reception.

Calcium channel blockers can have a negative inotropic effect, which can enhance the similar effect of itraconazole; Itraconazole is able to slow the metabolism of calcium channel blockers. Care should be taken with the simultaneous use of itraconazole and calcium channel blockers.

In patients with renal insufficiency, it is possible to decrease the bioavailability of itraconazole, in such cases a dose adjustment may be required.

With a reduced acidity of the stomach, the absorption of itraconazole is disrupted. Patients receiving antacid preparations (for example, aluminum hydroxide), it is recommended to take them not earlier than 2 hours after taking Rumikoza. Patients with achlorhydria, as well as patients taking histamine H2 receptor blockers or proton pump inhibitors, are recommended to take itraconazole with acidic drinks.

In very rare cases with the use of Rumikoza severe toxic liver damage developed, sometimes with acute hepatic insufficiency and lethal outcome. This was observed in patients with already existing liver diseases, as well as in patients receiving other medications,possessing a hepatotoxic effect. Several such cases occurred in the first month of therapy, and some in the first week of treatment. In this regard, it is recommended to regularly monitor liver function in patients receiving Rumikoz.

Treatment should be discontinued when neuropathy occurs, which may be associated with the administration of Rumikoza.

There is no evidence of cross-sensitivity to itraconazole and other azole antifungal agents. Rumikoz should be administered with caution to patients with hypersensitivity to other azole antifungal agents.

In patients with impaired immunity (AIDS, condition after organ transplantation, neutropenia), an increase in the dose of Rumikoza may be required.

Perhaps a joint appointment with antibiotics for the proliferation of candidiasis (thrush).

Impact on the ability to drive vehicles and manage mechanisms

Effects on the ability to drive and work with machinery were not observed.

Drug Interactions

Medicines that affect the absorption of itraconazole

Drugs that reduce the acidity of gastric juice, reduce the absorption of itraconazole.

Medicines that affect the metabolism of itraconazole

Itraconazole is mainly metabolized by the CYP3A4 isoenzyme. With simultaneous use with rifampicin, rifabutin, phenytoin, carbamazepine, isoniazid, which are powerful inducers of the isoenzyme CYP3A4, the bioavailability of itraconazole and hydroxy-itraconazole is significantly reduced, which leads to a significant decrease in the effectiveness of the drug (simultaneous application of Rumikoz with these drugs is not recommended).

Powerful inhibitors of the enzyme CYP3A4, such as ritonavir, indinavir, Clarithromycin and erythromycin, can increase the bioavailability of itraconazole.

Effect of itraconazole on the metabolism of other drugs

Itraconazole is able to inhibit CYP3A4-mediated metabolism of drugs, which can lead to an increase or prolongation of their effect, incl. side effects. After discontinuation of treatment with Rumikoz, the concentration of itraconazole in the plasma decreases gradually, depending on the dose and duration of treatment. This should be considered when combining therapy is necessary.

Drugs that can not be administered simultaneously with itraconazole

Calcium channel blockers, in addition to the possible pharmacokinetic interaction associated with common CYP3A4-mediated metabolism, can have a negative inotropic effect, which can enhance the similar effect exhibited by itraconazole.

Preparations, in the appointment of which it is necessary to monitor their concentration in the plasma, the effect, side effects:

• oral anticoagulants;
• HIV protease inhibitors (ritonavir, indinavir, saquinavir);
• antitumor drugs (vinca alkaloids pink, busulfan, docetaxel, trimetrexate);
• calcium channel blockers (dihydropyridine, verapamil) metabolized by the isoenzyme CYP3A4;
• immunosuppressive agents (cyclosporine, tacrolimus, sirolimus);
• HMG-CoA reductase inhibitors metabolized by the CYP3A4 isoenzyme;
• some glucocorticosteroids (GCS) (budesonide, dexamethasone and methylprednisolone);
• other drugs: digoxin, carbamazepine, buspirone, alfentanil, alprazolam, brothisolam, midazolam for IV introduction, rifabutin, ebastin, reboxetine, cilostazol, disopyramide, eletriptan, halofantrine, repaglinide.

If a simultaneous application with Rumikoza is required, a dose reduction of these drugs may be required.

Interactions between itraconazole and zidovudine, fluvastatin was not detected.

There was no effect of itraconazole on the metabolism of ethinylestradiol and norethisterone.

Studies have demonstrated the lack of interaction between itraconazole and propranolol, imipramine, diazepam, cimetidine, indomethacin, tolbutamide, sulfamethasin when bound to plasma proteins.

Analogues of the drug Rumikoz

Structural analogs for the active substance:

• Irunin;
• Itrazole;
• Itraconazole;
• Itramikol;
• Canditral;
• Miconiol;
• Orungal;
• Orungamine;
• Orunite;
• Tecnazol.

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