Capsules: size No. 0, firm gelatinous, yellow color; contents of capsules – spherical pellets of almost white or white color (in blister strip packagings: on 6 or 10 pieces, in a cardboard pack 1 packaging, on 7 pieces, in a cardboard pack 2 packagings);
Tablets are vaginal: almost white or white color, in the form of a ring (on 10 pieces in blister strip packagings, in a cardboard pack 1 packaging).

Active ingredient of Irunin – итраконазол:

1 capsule – 100 mg;
1 tablet vaginal – 200 mg.

Auxiliary components:

Capsules: copolymer of methacrylic acid (eudragit), a gipromelloz (gidroksipropilmetiltsellyuloz), пропилпарагидроксибензоат (нипазол), sucrose (sugar), methylparahydroxybenzoate (нипагин), a sugar krupka (starch syrup, sucrose (sugar));
Tablets are vaginal: potato starch, lactose (sugar milk), povidone (polyvinylpirrolidone), sodium lauryl sulfate, magnesium stearate, talc.

In addition as a part of capsules: gelatin, titanium dioxide, ferrous oxide yellow, methylparahydroxybenzoate (нипазол), methylparahydroxybenzoate (нипагин), acetic acid, dye sunset yellow (E110), dye quinolinic yellow (E104).

Indications to use

Capsules

System candidiasis and aspergillosis, cryptococcosis (including cryptococcal meningitis), a sporotrichosis, histoplasmosis, a zymonematosis, a paracoccidioidomycosis and other types of system mycoses;
Dermatomycoses;
Visceral candidiases;
Vulvovaginal candidiasis and other kandidomikozny infections with damage of mucous membranes and skin;
The onychomycoses caused by mold mushrooms, dermatophytes and/or yeast;
Fungal keratitis;
Chromophytosis.

Tablets are vaginal
The indication to use of vaginal tablets is vulvovaginal candidiasis, including a recurrent form.

Contraindications

Breastfeeding period;
Hypersensitivity to drug components.

During pregnancy of the capsule appoint in exceptional cases, only if the estimated advantage of treatment is much higher than the existing threat for a fruit.

At a superactivity of liver enzymes, an acute phase of diseases of a liver use of capsules is not desirable, except cases of justified risk if the expected advantage of therapy prevails over threat of damage of a liver.

It is necessary to be careful at purpose of capsules the patient with chronic heart failure (including the anamnesis), defeat of valves of heart, coronary heart disease, a renal failure, a chronic obstructive pulmonary disease.

Due to the lack of sufficient clinical data about use of capsules in pediatrics children are recommended to appoint drug only if the potential advantage of reception of Irunin surpasses possible risk.

Use of vaginal tablets in the I trimester of pregnancy is contraindicated, in II and III trimesters use is possible only in case of exceeding of the expected effect of therapy for the woman over potential risk for a fruit.

Route of administration and dosage

Capsules
Capsules accept inside, swallowing entirely, right after meal.

The dose of drug and the period of treatment are appointed by the doctor on the basis of clinical indications and the accompanying pathologies.

The recommended dosing:

Vulvovaginal candidiasis: on 200 mg 2 times a day within 1 day or in the same dose of 1 times a day within 3 days;
Chromophytosis: on 200 mg of 1 times a day within 7 days;
Dermatomycoses of smooth skin: on 200 mg of 1 times a day, treatment duration – 7 days or on 100 mg of 1 times a day – 15 days;
Fungal keratitis: on 200 mg of 1 times a day, a course of treatment – 21 days; at damages of hands and feet additional reception of capsules in a dose of 100 mg a day within 15 days is required;
Oral candidiasis: on 100 mg of 1 times a day;
Candidiasis: on 100-200 mg of 1 times a day (at the disseminated or invasive form – on 200 mg 2 times a day) lasting reception from 21 day up to 7 months;
Aspergillosis: on 200 mg of 1 times a day (at the invasive or disseminated form – in the same dose 2 times a day), a course of treatment from 60 days to 5 months;
Cryptococcosis (without meningitis): on 200 mg of 1 times a day, a reception course from 60 days to 12 months;
Cryptococcal meningitis: on 200 mg 2 times a day, a maintenance therapy – 200 mg of 1 times a day, duration of treatment is from 60 days up to 12 months;
Chromomycosis: on 100-200 mg of 1 times a day within 6 months;
Sporotrichosis: on 100 mg of 1 times a day within 3 months;
Histoplasmosis: on 200 mg 1-2 times a day, a therapy course – 8 months;
Parakoktsidiomikoz: on 100 mg of 1 times a day within 6 months;
Zymonematosis: on 100-200 mg 1-2 times a day, the treatment period – 6 months.

At purpose of capsules the patient with transplanted organs, a neutropenia, AIDS and other disturbances of immunity provided increase in a dose twice.

At an onychomycosis use of two types of therapy is possible:

Continuous treatment within 3 months with reception on 200 mg of Irunin of 1 times a day;
Administration of drug within 7 days on 200 mg 2 times a day with the subsequent break in 21 days. At fungal infections of nail plates of brushes 2 courses, stop – 3 courses are required.

The optimum mycologic and clinical effect of therapy occurs after drug withdrawal 14-30 days later at skin and 6-9 months at nail infections.

Tablets are vaginal
Tablets apply intravaginalno, enter into a vagina in a dorsal decubitus at the legs bent in knees. The procedure is carried out in the evening before going to bed.

Dosing mode: on 1 tablet of 1 times a day within 7-14 days.

Carrying out a repeated course perhaps after approval of the attending physician.

Side effects

Capsules

Nervous system: perhaps – fatigue, a headache, a peripheral neuropathy, dizziness;
Alimentary system: often – nausea, dyspepsia, a lock, abdominal pains; perhaps – anorexia, increase in activity of liver enzymes (reversible), hepatitis, cholestatic jaundice; in some cases – toxic damage of a liver, including a case of an acute liver failure with a lethal outcome;
Reproductive system: perhaps – disturbance of a menstrual cycle;
Cardiovascular system: perhaps – a fluid lungs, chronic heart failure;
Urinary system: a giperkreatininemiya, coloring of urine in dark color;
Metabolism: hyperpotassemia, hypostases;
Dermatological reactions: perhaps – an alopecia;
Allergic reactions: perhaps – a skin itch, rash, a Quincke's disease, a small tortoiseshell, Stephens-Johnson's syndrome.

Tablets are vaginal
At use of vaginal tablets there can seldom be local reactions: a burning sensation in a vagina, an itch, skin rash to areas of external genitals (drug withdrawal is not required).

Special instructions

Purpose of capsules is shown to patients with chronic heart failure in exceptional cases as Irunin has negative inotropic effect.

The patients with the lowered acidity of a stomach who are on simultaneous therapy by antiacid drugs are recommended to accept them in 2 hours after reception of capsules. It is necessary to wash down capsules with Coca at a combination to inhibitors of the protonew pump or blockers histamine _{H2 receptors} sick with an achlorhydria.

It is necessary to use reliable methods of contraception to women of childbearing age during reception of capsules up to approach of the first menstrual bleeding after completion of therapy.

With care it is necessary to use drug at patients with diseases of a liver or being on therapy by the medicines having a hepatotoxic action. Their treatment is recommended to be accompanied with regular control of function of a liver and careful observation of the doctor. At emergence of symptoms of development of hepatitis (weakness, abdominal pains, urine darkening, nausea, vomiting, anorexia) immediate cancellation of an itrakonazol and carrying out researches of function of a liver is required. At a liver disease in an active phase or the increased level of liver enzymes Irunin it is desirable not to appoint.

In case of signs of a neuropathy further use of capsules should be stopped.

Itrakonazol it is necessary to appoint with care at hypersensitivity to azoles in the anamnesis.

To avoid reinfection, use of vaginal tablets for the woman needs to be carried out at simultaneous treatment of the sexual partner and observance of rules of hygiene.

Sexual contacts during treatment by vaginal tablets are contraindicated.

In the absence of clinical effect and existence of symptoms of an infection after completion of therapy, carrying out a repeated microbiological research for confirmation of the diagnosis is required.

At development of allergic reaction introduction of tablets should be stopped, in need of immediate removal of drug it is possible to wash out a vagina boiled water.

Effect of drug does not influence ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

It is impossible to appoint итраконазол in combination with the drugs which are metabolized CYP3A4 isoenzyme, terfenadiny, mizolastiny, astemizoly, tsizapridy, midazolam (orally), triazolamy, dofetilidy, Pimozidum, quinidine, GMG-KOA-reduktazy inhibitors (ловастатин, симвастатин) – Irunin can cause prolongation or strengthening of their action and side effects. Level of maintenance of an itrakonazol in a blood plasma after cancellation decreases gradually, depending on duration of treatment and a dose.

The combination of an itrakonazol with blockers of calcium channels leads to strengthening of its negative inotropic effect and decrease in metabolism of blockers of calcium channels.

Efficiency of capsules decreases against the background of the concomitant use of a rifabutin, rifampicin, Phenytoinum which are strong inductors of microsomal enzymes of a liver and significantly reducing bioavailability of an itrakonazol. It is possible to assume similar effect at a combination with phenobarbital, carbamazepine, an isoniazid and other inductors of liver enzymes.

Bioavailability of drug can increase at a combination with ritonaviry, indinaviry, erythromycin, klaritromitsiny and other inhibitors of an isoenzyme CYP3A4 of system _{of P450 cytochrome}.

At simultaneous use of inhibitors of HIV protease (индинавир, ритонавир, саквинавир), peroral anticoagulants, some antineoplastic drugs (бусульфан, alkaloids of a periwinkle pink, триметрексат, dotsetakset), some immunodepressants (такролимус, cyclosporine, сиролимус) which are metabolized with the participation of an isoenzyme of CYP3A4 of blockers of calcium channels (verapamil, dihydropyridine), carbamazepine, digoxin, a buspiron, an alprazolam, an alfentanil, brotiozolam, Methylprednisolonum, a rifabutin, a reboksetin, the ebastina is required regular control of their concentration in a blood plasma. In need of their combination with itrakonazoly the dose of the specified means should be lowered.

With fluvastatiny and a zidovudine interaction is not revealed, influence of capsules on metabolism of Norethisteronum and ethinylestradiol is noted.

Researches confirmed lack of interaction of Irunin with propranolol, Imipraminum, diazepam, indometacin, Cimetidinum, Sulfamethazinum, Tolbutamidum, at linkng with proteins of plasma.

Medicinal interaction of an itrakonazol in the form of tablets vaginal at use in combination with other drugs is not established.