Rumikoz

Rumikoz – peroral antifungal drug.

Form of release and structure

Dosage form – capsules: the size No. 0, with the white case and a lid of pink-brown color; contents – spherical microgranules from light yellow till yellowish-beige color (on 6 or 5 pieces in blister strip packagings, in a cardboard pack respectively 1 or 3 packagings).

Active agent: итраконазол – 100 mg in 1 capsule.

Auxiliary components: half-oxameasures (лутрол), sucrose, gipromelloza, starch wheat, ferrous oxide black.

Structure of the capsule: titanium dioxide, gelatin, ferrous oxide red, yellow sunset, quinolinic yellow, azoruby.

Indications to use

• the onychomycoses caused by dermatophytes and/or mold mushrooms and yeast;
• candidiasis with damage of skin or mucous (including vulvovaginal candidiasis);
• fungal keratitis;
• chromophytosis;
• dermatomycoses;
• deep visceral candidiases;
• system mycoses: histoplasmosis, zymonematosis, sporotrichosis, aspergillosis, paracoccidioidomycosis, candidiasis, cryptococcosis (including cryptococcal meningitis), and also other system and tropical mycoses.

Contraindications

• simultaneous use of drugs which are metabolized with the participation of an isoenzyme of CYP3A4 and are capable to increase QT interval (a tsizaprid, a mizolastin, a dofetilid, an astemizol, quinidine, a sertindol, Pimozidum, a terfenadin, left methadone), peroral forms of midazolam and a triazolam, the inhibitors of GMG-KOA-reduktazy which are metabolized with participation of an isoenzyme of CYP3A4 (for example, a lovastatina, a simvastatina), drugs of alkaloids of an ergot (ergotamine, ergometrine, dihydroergotamine, methylergometrine);
• lactation period;
• hypersensitivity to Rumikoz's components.

With care:

• chronic renal failure;
• diseases of a liver and liver failure;
• heavy heart failure;
• hypersensitivity to other azolovy antifungal means.

To pregnant women and children drug is appointed only in exceptional cases, after careful assessment of a ratio of advantage and risks.

Route of administration and dosage

Rumikoz it is necessary to accept inside after food.

The recommended dosing modes at fungus diseases:

• chromophytosis: on 2 capsules 1 times/days within 7 days;
• fungal keratitis: on 2 капс. 1 times/days for 21 days;
• dermatomycoses of smooth skin: on 2 капс. 1 times/days a 7-day course or on 1 капс. 1 times/days within 15 days;
• oral candidiasis: on 1 капс. 1 times/days for 15 days;
• vulvovaginal candidiasis: on 2 капс. 2 times/days within 1 day or on 2 капс. 1 times/days course 3 days;
• defeats of the high-keratinized areas of an integument (hands and/or feet): on 2 капс. 2 times/days within 7 days or on 1 капс. 1 times/days for 30 days.

Depending on dynamics of a clinical picture of a disease the doctor can adjust treatment duration.

Because at immunity disturbances (for example, at the patients who transferred organ transplantation at a neutropenia or acquired immunodeficiency syndrome) bioavailability of the itrakonazol received orally can decrease, to these categories of patients increase in a daily dose can be required twice.

The recommended dosing modes at system mycoses:

• candidiasis: on 1-2 капс. 1 times/days a course, depending on the course of a disease, from 3 weeks to 7 months. If the disease has the invasive or disseminated form, the dose is increased to 2 капс. 2 times/days;
• aspergillosis: on 2 капс. 1 times/days within 2-5 months. If the disease has the invasive or disseminated form, the dose is increased to 2 капс. 2 times/days;
• sporotrichosis: on 1 капс. 1 times/days 3-month course;
• histoplasmosis: on 2 капс. 1-2 times/days within, as a rule, 8 months;
• chromomycosis: on 1-2 капс. 1 times/days for 6 months;
• zymonematosis: depending on weight of a course of a disease the dose can vary ranging from 1 капс. 1 times/days to 2 капс. 2 times/days, treatment duration – 6 months;
• paracoccidioidomycosis: on 1 капс. 1 times/days 6-month course;
• cryptococcosis (excepting meningitis): on 2 капс. 1 times/days, therapy duration depending on disease severity can vary from 2 months to 1 year;
• cryptococcal meningitis: on 2 капс. 2 times/days within 2-12 months (as a maintenance therapy).

Depending on a type of an infection and features of a course of a disease the doctor can adjust doses.

At an onychomycosis one of two schemes of treatment is applied:

• pulse therapy: on 2 капс. 2 times/days within 7 days, all spend 2 (at defeat of nail plates of hands) or 3 (at defeat of nail plates of feet) such a bucketed course 3 weeks between courses;
• continuous therapy (at defeat of nail plates of feet without defeat or with defeat of nail plates of hands): on 2 капс. 1 time a day a 3-month course.

As out of skin and nail plates итраконазол it is brought more slowly, than out of a blood plasma, optimum mycologic and clinical effects are reached in 2-4 weeks after the end of treatment of skin defeats and in 6-9 months after the end of therapy of diseases of nails.

Side effects

• allergic reactions: skin rashes, urticaria, skin itch, Quincke's disease; seldom – Stephens-Johnson's syndrome (a mnogoformny exudative erythema);
• dermatological reactions: photosensitization, alopecia;
• from the central and peripheral nervous system: dizziness, headache, peripheral neuropathy;
• from the alimentary system: reversible increase in activity of liver enzymes, diarrhea/lock, loss of appetite, nausea, abdominal pain, dyspepsia, vomiting, hepatitis; seldom or never – crushing toxic damage of a liver, including an acute liver failure with a lethal outcome;
• others: coloring of urine in dark color, an edematous syndrome, a giperkreatininemiya, a hypopotassemia, a fluid lungs, congestive heart failure, disturbances of a menstrual cycle.

Special instructions

Patients with a cryptococcosis of the central nervous system and an immunodeficiency Rumikoz can appoint only when drugs of the first line cannot be used in these cases or were inefficient.

Women of childbearing age should use reliable methods of contraception during all course of treatment up to the first periods after its termination.

Itrakonazol possesses a negative inotropic effect in this connection increases risk of development of heart failure. For this reason for patients with chronic heart failure (in the anamnesis including) Rumikoz can be appointed only in cases if the expected advantage exceeds potential risks.

At a renal failure bioavailability of an itrakonazol can decrease therefore dose adjustment can be required.

At simultaneous use of antiacid drugs Rumikoz it is necessary to accept a minimum in 2 hours after them.

The patient with an achlorhydria and to the patients receiving inhibitors of a protonew pomp or blockers of histamine _{H2 receptors}, it is recommended to accept drug with acid drinks.

Very exceptional cases of development of crushing toxic damages of a liver, including with an acute liver failure and a lethal outcome are known. This side effect of Rumikoz was observed at people with associated diseases of a liver and the persons who are receiving medical treatment for drugs with a hepatotoxic action. In this regard during treatment it is necessary to control function of a liver regularly.

In case of development of a neuropathy therapy itrakonazoly should be stopped.

The negative impact of drug on the speed of reactions and ability to concentration of attention was not noted.

Medicinal interaction

Whenever possible it is not necessary to apply along with itrakonazoly blockers of calcium channels as they can also render a negative inotropic effect which at use of this combination can amplify.

Powerful inductors of an isoenzyme CYP3A4 (рифабутин, rifampicin, an isoniazid, carbamazepine) considerably reduce bioavailability of an itrakonazol, significantly reducing its efficiency therefore such combination is undesirable.

Powerful inhibitors of CYP3A4 enzyme (for example, erythromycin, кларитромицин, индинавир and ритонавир) can increase bioavailability of an itrakonazol.

The drugs reducing acidity of a gastric juice reduce absorption of an itrakonazol.

Itrakonazol is capable to suppress CYP3A4 - the mediated metabolism of drugs owing to what strengthening or prolongation of their effects, including collateral is possible. After Rumikoz's cancellation concentration of an itrakonazol in a blood plasma decreases gradually, depending on the applied dose and duration of therapy. These data should be considered in need of carrying out a combination therapy.

At co-administration of the following drugs it is necessary to watch their concentration in a blood plasma, action and side effects:

• antineoplastic drugs (триметрексат, бусульфан, alkaloids of a periwinkle pink, dotsetakset);
• the blockers of calcium channels (for example, verapamil or dihydropyridine) which are metabolized CYP3A4 isoenzyme;
• peroral anticoagulants;
• immunodepressive means (такролимус, cyclosporine, сиролимус);
• some glucocorticosteroids (dexamethasone, будесонид, Methylprednisolonum);
• HIV protease inhibitors (индинавир, ритонавир, саквинавир);
• the GMG-KOA-reduktazy inhibitors which are metabolized with participation of an isoenzyme of CYP3A4;
• other medicines: midazolam for intravenous administration, репаглинид, alfentanit, carbamazepine, рифабутин, цилостазол, to alprazola, digoxin, элетриптан, эбастин, Disopyramidum, буспирон, галофантрин, ребоксетин, brotiozolam.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 2 years.