Микомакс

Микомакс – antifungal means.

Form of release and structure

Dosage forms:

• Capsules: opaque, with the case of white color and black marking (on capsules with a lid of blue color - "MYCO 100", on capsules with a blue lid - "MYCO 150"), in capsules – powder white with a yellow shade or almost white color (on 100 mg – on 7 pieces in blisters, in a cardboard pack of 1, 4 or 10 blisters; on 150 mg – on 1 or 3 pieces in blisters, in a cardboard pack 1 blister);
• Solution for infusions: colourless transparent liquid (on 100 ml in glass bottles of dark color, in a cardboard pack 1 bottle);
• Syrup: transparent liquid without color (on 100 ml in bottles, in a cardboard pack 1 bottle with a measured glass in a set).

Active ingredient of Mikomaks – флуконазол:

• 1 capsule – 100 mg or 150 mg;
• 1 ml of solution – 2 mg;
• 1 ml of syrup – 5 mg.

Auxiliary components:

• Capsules: starch prezhelatinizirovanny, lactoses monohydrate, silicon dioxide colloid, sodium lauryl sulfate, magnesium stearate;
• Solution: sodium chloride, water for injections;
• Syrup: sodium saccharin, sorbitol of 70% liquid, Natrium benzoicum, глицерол 85%, fragrance cherry, citric acid monohydrate, sodium of a karmelloz, the water purified.

Structure of a cover of capsules: gelatin, Patent blue dye (E131), blackened black Attramentum nigrum (ferrous oxide black, shellac, N butanol, lecithin soy, industrial metilirovanny alcohol, the defoamer DC 1510), titanium dioxide (E171).

In addition as a part of capsules with a blue lid ("MYCO 100") – dye ferrous oxide yellow.

Indications to use

• Generalized candidiasis, including the disseminated candidiasis, kandidemiya, invasive candidosis infections of a peritoneum, an eye, respiratory tracts, an endocardium, an urinary system;
• Cryptococcal meningitis, cryptococcal infections of skin and lungs, other localizations of a cryptococcosis at patients with normal immunity and with different forms of immunosuppression (including arisen against the background of organ transplantation and at patients with AIDS), prevention of a cryptococcosis at patients with AIDS;
• Acute and chronic recurrent form of vaginal candidiasis;
• Candidiasis of mucous membranes (including a gullet, an oral cavity, a throat), noninvasive bronchopulmonary candidiases, a kandiduriya;
• Prevention of fungus infectious diseases at malignant new growths at predisposed patients after performing radiation therapy or chemotherapy with cytostatics.

Besides, Mikomaks's use in capsules and in the form of syrup is shown:

• Candidosis balanitis, prevention of frequency of a recurrence of vaginal candidiasis at patients with three and more episodes of a disease a year;
• Onychomycosis, chromophytosis, skin mycoses (including mycosis of a body, feet, inguinal area), skin candidiasis;
• Deep local mycoses at patients with normal immunity, including паракокцидиомикоз, кокцидиомикоз, histoplasmosis and a sporotrichosis;
• Prevention of development of a recurrence of oropharyngeal candidiasis in patients with AIDS.

Contraindications

• Concomitant use of an astemizol, terfenadin (in need of reception of a flukonazol in a daily dose from 400 mg and more (for capsules)), a tsizaprid and other means promoting lengthening of an interval of QT;
• Breastfeeding period;
• Hypersensitivity to a flukonazol or relatives on structure to azolny compounds and auxiliary components of drug.

Use of drug during pregnancy is contraindicated, except cases of severe generalized forms of fungal infections, life-threatening swear, and also if the expected clinical effect exceeds potential harm for a fruit.

With care it is recommended to appoint Mikomaks to patients with a liver failure.

Besides, contraindications to use of capsules are:

• Glyukozo-galaktozny malabsorption, inborn intolerance of a galactose, insufficiency of lactase;
• Weight is less than 40 kg.

With care it is necessary to appoint capsules sick with a liver failure; at a concomitant use of a flukonazol in a dose it is lower than 400 mg in days and a terfenadin; at use against the background of therapy of sulphonylurea derivatives by Mikomaks (risk of increase in probability of development of a hypoglycemia), peroral hypoglycemic drugs.

It is necessary to be careful, applying solution at patients with a renal failure, with special attention to continue treatment by solution at patients with skin rashes against the background of Mikomaks's use at a superficial, invasive or system fungal infection.

Regular medical observation at use of capsules and solution in the period of proaritmogenny states is required from patients with risk factors (organic pathologies of heart, disturbance of electrolytic balance, a concomitant use of the means causing arrhythmia).

With care appoint syrup at a renal failure, alcoholism, a combination to potentially gepatotoksichny means, aged up to 6 months.

Route of administration and dosage

• Capsules: accept inside;
• Solution: enter intravenously (in/in) kapelno, infusion speed no more than 20 mg (10 ml) a minute. For preparation of infusion solution it is possible to use 20% glucose solution, chloride potassium solution in glucose, Ringer's solution, isotonic solution of sodium of chloride, Hartman's solution, 4,2% bicarbonate sodium solution. It is not necessary to change a dose at transfer of the patient into administration of drug inside;
• Syrup: accept inside by means of a measured glass. Before a proglatyvaniye it is necessary to take syrup 2 minutes in a mouth. The special cover of a bottle opens opposite to the movement of an hour hand aside after some strengthened pressing.

At treatment of adults and children the doctor appoints a dose and the period of use of Mikomaks on the basis of clinical indications and the accompanying pathologies.

The recommended dosing for adults:

• Cryptococcal meningitis and other localizations of cryptococcal infections: in the first day of therapy of 400 mg (80 ml), then – 200-400 mg (40-80 ml) of 1 times a day. The period of treatment depends on the clinical effect confirmed with a mycologic research, for cryptococcal meningitis it usually lasts not less than 6-8 weeks;
• Prevention of a recurrence of cryptococcal meningitis at patients with AIDS: 200 mg a day (40 ml) after a full course of primary therapy, for a long time;
• Kandidemiya, the disseminated candidiasis and other invasive candidosis infections: in the first days – 400 mg (80 ml), and then – 200 mg (40 ml) of 1 times a day. For achievement of clinical effect increase in a dose to 400 mg (80 ml) in days is allowed. After an intensive course of antineoplastic chemotherapy, transplantation of marrow, extensive surgical interventions on heart or bodies of digestive tract the patient showed purpose of an initial dose from calculation po10 to mg on 1 kg and supporting – on 5 mg on 1 kg of weight of the patient a day. The period of treatment depends on clinical effect and is defined individually;
• Orofaringealny candidiasis: 50-100 mg (10-20 ml) of 1 times a day within 7-14 days, at considerable decrease in immunity a course of treatment can be prolonged;
• Atrophic candidiasis of an oral cavity (against the background of carrying dentures): 50 mg (10 ml) of 1 times a day, a course of treatment of 14 days in a combination with antiseptic drugs for processing of a prosthesis;
• Esophagitis, noninvasive bronchopulmonary candidiasis, a kandiduriya, candidiasis of mucous membranes and skin, other localizations of candidiasis (except genital): 50-100 mg (10-20 ml) of 1 times a day within 14-30 days;
• Prevention of a recurrence of oropharyngeal candidiasis at patients with AIDS: 150 mg (30 ml) once a week after a full course of primary therapy;
• Vaginal candidiasis, the balanitis caused by Candida: 150 mg (30 ml) once inside. The patient with three and more palindromias a year for decrease in frequency of vaginal candidiasis usually appoint preventive administration of drug in a dose of 150 mg (30 ml) within 4-12 months once a month. More frequent reception can be necessary for some patients;
• Prevention of candidiasis: 50-400 mg (10 - 80 ml) of 1 times a day. The dose and the period of treatment depend on a risk degree of development of a fungal infection;
• Mycosis of skin of feet, inguinal area and skin candidiasis: 150 mg (30 ml) once a week or 50 mg (10 ml) of 1 times a day. Duration of treatment is 2-4 weeks, at mycoses of feet – up to 6 weeks;
• Chromophytosis: 300 mg (60 ml) once a week, a course of treatment 1-3 weeks or on 50 mg (10 ml) once a day within 2-4 weeks;
• Onychomycosis: 150 mg (30 ml) once a week, continue treatment before full growth of not infected nail (on fingers of hands – 3-6 months, stop – 6-12 months);
• Deep local mycoses: 200-400 mg (40-80 ml) of 1 times a day, determine duration individually (at a koktsidiomikoza – 11-24 months, a parakoktsidiomikoza – 2-17 months, a sporotrichosis – 1-16 months, histoplasmosis – 3-17 months).

At treatment of children of Mikomaks apply 1 time a day in the dose calculated taking into account the child's weight, but no more that at adult patients.

The recommended daily dosing for children:

• Candidiasis of mucous membranes: in the first day – on 6 mg on 1 kg, then – 3 mg on 1 kg of weight of the child;
• Generalized candidiasis and cryptococcal infections: on 6-12 mg on 1 kg of weight;
• Prevention of fungal infections at reduced immunity at children with the neutropenia developing against the background of beam or cytotoxic chemotherapy: on 3-12 mg on 1 kg, the dose depends on duration of preservation and expressiveness of the induced neutropenia.

Because of the slowed-down removal of a flukonazol at newborns, in the first 2 weeks of life of the child it is recommended to administer the drug at an interval of the 72nd hour, the next 2-4 weeks – at an interval of 48 hours.

Dose adjustment is not required to patients of advanced age (in the absence of renal failures).

At patients with functional disorders of kidneys at a single dose of drug the dose is not changed. At repeated use the daily dose should be lowered taking into account degree of manifestation of renal pathology, it is recommended to enter at first a shock dose of 50-400 mg, further – at the clearance of creatinine (CC) more than 50 ml/min. are applied the usual recommended dose, at KK of 11-50 ml/min. sick appoint ½ usual doses. The patient who is on regular dialysis, recommends reception of one dose of drug after each session of a hemodialysis.

Side effects

• Alimentary system: nausea, vomiting, diarrhea, abdominal pains, changes of flavoring feelings, a meteorism, an abnormal liver function (jaundice, гепатонекроз (including with a lethal outcome), hepatitis, a hyperbilirubinemia, increase in activity of alaninaminotranspherase, aspartate aminotransferase, an alkaline phosphatase);
• Nervous system: often – a headache; infrequently – dizziness, spasms;
• System of a hemopoiesis: seldom – a leukopenia, an agranulocytosis, a neutropenia, thrombocytopenia;
• Urinary system: functional disorders of kidneys;
• Metabolism: seldom – a gipertriglitseridemiya, a hypercholesterolemia, a hypopotassemia;
• Dermatologicheky reactions: alopecia, skin rash;
• Allergic reactions: Stephens-Johnson's syndrome, toxic epidermal necrolysis, anaphylactoid reactions.

Besides, Mikomaks's reception in the form of capsules can cause side effects:

• General disturbances: infrequently – weakness (including muscular), motive concern, fever;
• Dermatologicheky reactions: often – skin rash; infrequently – the strengthened sweating, an itch; very seldom – a mnogoformny exudative erythema;
• Nervous system: infrequently – a tremor, paresthesias, вертиго;
• Alimentary system: infrequently – a xerostomia, a lock, anorexia, dyspepsia, a cholestasia, damage of hepatic fabric; seldom – a liver failure;
• Mental disorders: infrequently – drowsiness, sleeplessness;
• Immune system: very seldom – an itch, a face edema, an anaphylaxis, a Quincke's disease;
• System of a hemopoiesis: infrequently – anemia;
• Skeletal and muscular system: infrequently – a mialgiya.

Use of solution can cause disturbances of cardiovascular system in the form of trembling or ventricular fibrillation, increase in duration of an interval of QT.

Development of allergic reactions (skin rash) can become also undesirable effect at reception of syrup.

Side effects of drug arise at HIV-positive patients more often.

Special instructions

Treatment of all clinical indications needs to be continued before full clinical laboratory remission as premature drug withdrawal leads to palindromias. Mikomaks's use should be accompanied with regular control of function of a liver and kidneys, hematologic indicators.

Exceptional cases of toxic changes of a liver, including with a lethal outcome, were generally celebrated against the background of the accompanying serious illness. Explicit dependence of hepatotoxic effects of a flukonazol on a daily dose, the period of treatment, age or a sex of the patient is noted, action usually has reversible character. Therefore at emergence of symptoms of an abnormal liver function and/or kidneys it is necessary to cancel administration of drug.

Tendency to development of heavy skin pathologies in patients with AIDS against the background of reception of many drugs requires special attention to this category of patients. If emergence of skin rash at a superficial fungal infection can be referred definitely to action of a flukonazol, drug needs to be cancelled. At invasive or system fungal infections the developing rash should be observed carefully and only in case of a mnogoformny erythema or violent changes to stop treatment flukonazoly.

It is recommended to appoint with care drug at a concomitant use of a rifabutin and other means which are metabolized by means of the isofermental R-450 system.

In rare instances effect of drug causes lengthening of an interval of QT and development of ventricular tachycardia like pirouette. More often this effect is observed at a serious illness of heart and multiple factors of risk, such as concomitant use of the means promoting disturbance of a rhythm, a myopathy and disturbance of water and electrolytic balance.

Usually Mikomaks's use does not exert impact on ability of the patient to control of vehicles and mechanisms. However when developing dizziness, drowsiness, вертиго, the patient should refuse performance of potentially dangerous types of activity.

Medicinal interaction

Simultaneous use of Mikomaks with other medicines needs to be begun only after consultation with the attending physician, it will allow to avoid development of clinically significant undesirable reactions.

Terms and storage conditions

To store in the place, unavailable to children:

• Capsules: at a temperature up to 25 °C;
• Solution and syrup: in the protected from light, dry place at a temperature of 10-25 °C.

Period of validity – 3 years.