Mycomax

Mycomax is an antifungal drug.

Release form and composition

Mikomax is produced in the form of capsules: the body is opaque, white, with a black inscription (depending on the dosage) "MYKO 50", "MYKO 100" or "MYKO 150"; the lid is opaque, light blue (50 mg), blue (100 mg) or blue (150 mg), the contents of the capsule are powder from almost white with a yellowish tinge to white (7 pieces each (50 or 100 mg capsules ) or 1 or 3 pieces (150 mg capsules) in blisters, 1 pack in a carton box).

The composition of 1 capsule includes:

• Active ingredient: fluconazole - 50, 100 or 150 mg;
• Auxiliary components: pregelatinized starch, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate.

Capsule composition: black ink (Attramentum nigrum; black ferric oxide, shellac, n-butanol, soy lecithin, methylated industrial alcohol, antifoaming agent DC 1510), Patent blue (E131) dye, gelatin, titanium dioxide; additionally capsules of 100 mg: iron dye oxide yellow.

Indications for use

• Cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including skin, lungs). Mycomax is prescribed to patients with a normal immune response and various forms of immunosuppression (including patients with acquired immunodeficiency syndrome (AIDS), as well as in organ transplantation). If necessary, the drug is used to prevent the recurrence of cryptococcal infections in patients with AIDS;
• Generalized candidiasis, including candidemia, disseminated candidiasis and other types of invasive candidal infections (infections of the eye, endocardium, peritoneum, urinary and respiratory tract, spleen, liver and other organs). Therapy can be carried out in patients with malignant neoplasms, in patients in intensive care units who are undergoing immunosuppressive or cytostatic therapy, as well as in patients with other factors predisposing to the occurrence of candidiasis;
• Candidiasis of the mucous membranes (including candidiasis of the esophagus, pharynx and oral cavity), candiduria, bronchopulmonary non-invasive candidiasis, candidiasis of the skin in patients with normal and reduced function of the immune system. If necessary, Micomax is prescribed for the prevention of recurrence of oropharyngeal candidiasis in AIDS patients;
• Genital candidiasis: candidal balanitis; vaginal candidiasis (chronic recurrent and acute), prevention of frequent recurrences of vaginal candidiasis (from 3 episodes per year);
• Mycoses of the skin, including mycoses of the groin, body, feet; onychomycosis, pityriasis versicolor; skin candidiasis;
• Deep endemic mycoses (including paracoccidioidomycosis, coccidiomycosis, histoplasmosis, sporotrichosis) in patients with a normal immune response;
• Prevention of fungal infections in patients with malignant tumors who, due to radiation therapy or cytostatic therapy, are prone to developing such infections.

Contraindications

• Lactase deficiency, congenital intolerance to galactose, glucose-galactose malabsorption (due to lactose in the formulation);
• Simultaneous administration with terfenadine (if necessary, receive Mikomax at a dose of 400 mg per day);
• Simultaneous intake with astemizole and cisapride (due to the risk of prolonged QT interval and the occurrence of ventricular tachycardia, including ventricular pirouette tachycardia);
• Body weight in children less than 40 kg (for capsules of 100 and 150 mg);
• Lactation period;
• Hypersensitivity to the components of the drug, as well as azole compounds close in structure.

Mikomax should be taken with caution in the following diseases / conditions:

• Hepatic and renal failure (dose adjustment is required);
• Potentially proarrhythmic states in patients with multiple risk factors (water and electrolyte imbalance, organic heart disease, simultaneous use of drugs causing arrhythmias);
• Simultaneous administration with terfenadine (when taking Micomax at a dose of less than 400 mg per day);
• Simultaneous use with oral hypoglycemic drugs, sulfonylurea derivatives (due to the increased risk of hypoglycemia, careful monitoring of glucose concentration in the blood is necessary, correction of hypoglycemic therapy is possible);
• Pregnancy.

Dosing and Administration

Mikomaks accept inside.

Dosing regimen is determined by indications.

Adults are usually prescribed:

• Cryptococcal meningitis and cryptococcal infections of other sites: on the first day - 400 mg, and then - once a day, 200-400 mg. The duration of therapy is determined by confirmed mycological research of clinical efficacy. Treatment for cryptococcal meningitis usually lasts from 6 weeks to 2 months. After completing the full course of primary treatment to prevent the recurrence of cryptococcal meningitis in AIDS patients, Micomax is prescribed for a long time at 200 mg per day;
• Candidemia, disseminated candidiasis and other invasive candidal infections: 400 mg on the first day, and later - once a day, 200 mg. With insufficient clinical efficacy, it is possible to increase the daily dose by 2 times (up to 400 mg); with life-threatening candidal infections - up to 800 mg per day. The duration of therapy is determined by confirmed mycological research of clinical efficacy;
• Candidiasis of the pharynx and oral cavity: 1 time per day, 100 mg. The duration of therapy is 1-2 weeks. In patients with a pronounced decrease in immunity, if necessary, therapy may be longer;
• Other localization of candidiasis (except genital candidiasis), for example, esophagitis, non-invasive bronchopulmonary lesion, candiduria, candidiasis of the skin and mucous membranes: 100 mg once a day. The duration of therapy is from 2 weeks to 1 month;
• Prevention of relapses of oropharyngeal candidiasis in AIDS patients: 150 mg 1 time per week after completing the full course of primary treatment;
• Vaginal candidiasis: 150 mg once. To reduce the frequency of recurrences of vaginal candidiasis, Mycomax is prescribed 150 mg once a month. The duration of the course the doctor determines individually. Usually it is 4-12 months. In some cases, it may increase the frequency of taking the drug;
• Candida balanitis: 150 mg once. Depending on the degree of risk of developing a fungal infection, the recommended daily dose for the prevention of candidiasis is 50-400 mg. High doses (400 mg per day) are usually prescribed if there is a high risk of a generalized infection, for example, in patients with long-lasting or severe neutropenia. Mycomax is taken several days before the expected development of neutropenia. After increasing the number of neutrophils greater than 1000 / mm³, therapy is continued for another week;
• Candidiasis and mycoses of the skin, including mycoses of the skin of the groin, stop: 150 mg once a week. Typically, the duration of the course is 2-4 weeks, with mycoses of the feet, longer therapy is possible - up to 6 weeks;
• Pityriasis versicolor: 300 mg 1 time per week for 2 weeks. Some patients may require a third dose (300 mg) per week, in some cases, a single dose of 300-400 mg of Micomax is sufficient. It is also possible to take 1 time a day, 50 mg for 2-4 weeks;
• Onychomycosis: 150 mg once a week. Therapy should be continued until complete replacement of the affected nail with a healthy one. As a rule, this occurs for 3-6 months, and for lesions of the nails of the big toes - 6-12 months. After the chronic course of the nail infection is cured, the deformation of the nail plates may persist;
• Deep endemic mycoses: 200-400 mg per day for a long time (for 2 years). The duration of the course the doctor determines individually. It can be: coccidiomycosis - 11-24 months; paracoccidiomycosis - 2-17 months; sporotrichosis - 1-16 months; histoplasmosis - 3-17 months.

As with infections in adults, the duration of therapy in children is determined by the clinical and mycological effect. The daily dose of Micomax in children is determined by the body weight, but it should not be higher than the adult. The frequency of taking the drug - 1 time per day.

In children, the following dosing regimens are used:

• Candidiasis of the mucous membranes: 3 mg / kg per day. To quickly achieve constant equilibrium concentrations, a loading dose of 6 mg / kg can be prescribed on the first day of use;
• Generalized candidiasis or cryptococcal infection: 6-12 mg / kg per day (depending on the severity of the disease);
• Prevention of fungal infections in children with reduced immunity, in whom the risk of infection is associated with neutropenia caused by radiation therapy or cytotoxic chemotherapy: 3-12 mg / kg per day (depending on the duration of preservation and the severity of induced neutropenia).

Patients with functional disorders of the kidneys with a single dose of Micomax do not need to change the dose. With coursework at the beginning of treatment, a loading dose of the drug (50-400 mg) is indicated. When creatinine clearance is more than 50 ml per minute, a dose change is not required; when creatinine clearance is 11-50 ml per minute, ½ of the recommended dose should be taken. Regularly being on dialysis patients, after each session of hemodialysis prescribed the usual dose of the drug.

The daily dose of Micomax for children with functional disorders of the kidneys should be reduced in the same proportion as for adults.

Elderly patients with normal renal function dose adjustment is not required.

Side effects

As a rule, Micomax is well tolerated.

During the use of Micomax, the following side effects may occur (very often -> 1/10; often - from ≥1 / 100 to <1/10; infrequently - from ≥1 / 1000 to <1/100; rarely - from ≥1 / 10,000 to <1/1000; very rarely - <1/10000 (including individual messages); with an unknown frequency - if it is impossible to determine the frequency of occurrence of violations from the available data):

• Nervous system: often - headache; infrequently - convulsions, dizziness, paresthesia, tremor;
• Immune system: rarely - anaphylaxis;
• Gastrointestinal tract: often - abdominal pain, nausea and vomiting, diarrhea; infrequently - dyspepsia, anorexia, constipation, dryness of the oral mucosa, flatulence, changes in taste;
• Liver and biliary tract: often - clinically significant increase in the activity of aspartate aminotransferase, alanine aminotransferase, increase in alkaline phosphatase activity; infrequently, liver tissue damage, cholestasis, jaundice, hyperbilirubinemia; rarely, liver necrosis;
• Skin and subcutaneous tissue: often - skin rash; infrequently - excessive sweating, itching; rarely, exfoliative skin lesions (Stevens-Johnson syndrome);
• Musculoskeletal and connective tissue: infrequently - myalgia;
• Mental disorders: infrequently - drowsiness, insomnia;
• Blood and lymphatic system: infrequently - anemia;
• General disorders: infrequent - motor restlessness, weakness, fever, muscular weakness.

Side effects are more common in people infected with human immunodeficiency virus (HIV) than in HIV-uninfected patients.

During the postmarketing research of Mikomax, the following violations were also noted:

• Nervous system: rarely - seizures;
• Immune system: very rarely - swelling of the face, anaphylaxis, angioedema, pruritus; with unknown frequency - anaphylactoid reactions;
• Blood and lymphatic system: rarely - leukopenia (including agranulocytosis and neutropenia), thrombocytopenia;
• Liver and biliary tract: rarely - hepatitis, liver failure, liver necrosis, including fatal;
• Kidneys and urinary tract: with unknown frequency - functional disorders of the kidneys;
• Skin and subcutaneous tissues: rarely - alopecia, very rarely - exudative erythema multiforme, exfoliative skin lesions (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• Metabolism and nutrition: rarely - hypertriglyceridemia, hypercholesterolemia, hypokalemia.

special instructions

The use of Micomax for all indications should be continued until the onset of clinical and laboratory remission. Discontinuation of therapy ahead of time may result in relapse. During treatment, liver and kidney function, as well as hematological parameters should be monitored.

In severe heart pathologies and such multiple risk factors as water and electrolyte imbalance, myopathy, and simultaneous use with drugs that contribute to the occurrence of arrhythmias, ventricular tachycardia of the “pirouette” type and QT interval can develop.

Sometimes the use of Mikomax is accompanied by toxic liver damage, including fatal outcome (usually in patients with serious concomitant diseases). With the development of hepatotoxic effects associated with the therapy, there was no obvious dependence of their occurrence on the duration of therapy, the total daily dose, age and sex of the patient. As a rule, the hepatotoxic effect of the drug is reversible; after cessation of therapy, its symptoms disappear. If there are signs of the development of functional disorders of the liver, treatment should be stopped. Also, therapy is canceled in the development of renal dysfunction.

If a rash appears in AIDS patients with a superficial fungal infection and is regarded as definitely associated with the treatment being carried out, Micomax should be canceled. When a rash occurs with invasive / systemic fungal infections, the condition of patients should be carefully monitored. With the appearance of pathologies such as erythema multiforme or bullous changes, the drug should be discontinued. Care must also be taken when applying Mikomax with rifabutin or other drugs that are metabolized with the P-450 isozyme system.

In the event of the development of such side effects as dizziness or drowsiness, it is recommended to abandon driving vehicles and performing potentially hazardous types of work.

Drug interaction

With the simultaneous use of Micomax with some drugs, undesirable effects may occur:

• Coumarin derivatives (warfarin): an increase in prothrombin time (requires careful monitoring);
• Terfenadine: a significant increase in its plasma concentration, the occurrence of serious rhythm disturbances (simultaneous administration of Micomax at a dose of 400 mg per day is contraindicated, up to 400 mg per day — possible under close observation);
• Astemizol and other drugs metabolized by isoenzymes of the cytochrome P450 system: an increase in their plasma concentrations (monitoring of the patient’s condition is necessary);
• Hydrochlorothiazide: increased plasma concentrations of Micomax;
• Oral hypoglycemic agents, sulfonylurea derivatives: an increase in their plasma concentrations and the likelihood of hypoglycemia (you may need to adjust the doses of these drugs);
• Midazolam: an increase in its concentration and the risk of psychotic affects (dose adjustment may be required, careful monitoring of the patient’s condition is necessary);
• Phenytoin: a clinically significant increase in its concentration in the blood (dose adjustment may be necessary);
• Rifampicin: reduction of the half-life and plasma concentration of Micomax (correction of its dose may be required);
• Rifabutin: an increase in its plasma concentration, the likelihood of developing uveitis (careful monitoring of the patient’s condition is necessary);
• Cisapride: development of cardiac disorders, including ventricular tachycardia of the “pirouette” type (simultaneous use is contraindicated);
• Theophylline: an increase in its plasma concentrations (in the presence of the likelihood of theophylline intoxication, careful monitoring of the patient’s condition is necessary for early detection of theophylline overdose signs);
• Zidovudine: an increase in its plasma concentrations (control of the development of adverse reactions associated with zidovudine is necessary);
• Tacrolimus: an increase in its plasma concentrations (controlling the development of toxicity, including hyperglycemia, nephrotoxicity, hyperkalemia, dose adjustment may be necessary).

During therapy, it is necessary to take into account that research on drug interactions with other drugs has not been conducted, but their occurrence is possible.

Terms and conditions of storage

Keep out of reach of children at temperature up to 25 ° C.

Shelf life - 3 years.