Mikosist capsules 150mg №1

Mechanism of action

Antifungal drug, a derivative of bistriazole. The mechanism of action is due to the inhibition of the synthesis of ergosterol, which is part of the cell membrane of fungi. Mikosist has a highly specific effect on fungal enzymes that are dependent on cytochrome P₄₅₀.
Mikosist active against Candida spp., Cryptococcus neoformans, Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis, Microsporum spp., Trichophyton spp.

Indications and usage

- chronic generalized (granulomatous) candidiasis;
- visceral candidosis of the endocardium, abdominal organs, respiratory and urogenital systems;
- candidiasis of the eye;
- candidemia;
- Candiduria;
- Candidiasis of the mucous membranes of the oral cavity (including when wearing dental prostheses), pharynx, esophagus, non-invasive candidiasis of the bronchi and lungs;
- candidiasis of the skin, nail rollers, nails;
- genital candidiasis (acute and chronic recurrent vaginal candidiasis, prevention of recurrent vaginal candidiasis / 3 or more episodes per year /, candidal balanitis);
- cryptococcosis of various localization (including respiratory organs, mucous membranes);
- cryptococcal meningitis;
- dermatophytes resistant to local therapy (foot mycosis, smooth skin mycosis);
- pityriasis versicolor;
- onychomycosis;
- endemic mycoses (coccidioidomycosis, paracoccidioidomycosis, sporotrichosis, histoplasmosis in patients with normal immunity).

Contraindications

Hypersensitivity to Fluconazole and other azole derivatives in the anamnesis.

Dosage and administration

Treatment can begin before the results of seeding and other laboratory tests. However, further dose adjustment is necessary.
The daily dose of Mycosyst depends on the nature and severity of mycotic infection. Treatment must continue until clinical and laboratory remission is achieved. With cryptococcal meningitis, recurrent oropharyngeal candidiasis, AIDS patients need long-term use of the drug in maintenance doses.
For adults with cryptococcosis different localization of the drug is prescribed in a dose of 400 mg on the 1st day of treatment, then 200-400 mg 1 time / day. The duration of treatment depends on the clinical picture and laboratory data.
With cryptococcal meningitis treatment is at least 6-8 weeks.
For the prevention of recurrence of meningitis in AIDS patients Mycosyst is prescribed after completing the course of treatment in a maintenance dose of 200 mg / day for a long time.
In chronic generalized (granulomatous) candidiasis, candidemia, visceral candidiasis Mycosyst is prescribed in a dose of 400 mg on the 1st day of therapy, then 200 mg / day. If necessary, the daily dose may be increased to 400 mg. The duration of treatment is determined by the patient's condition.
When oropharyngeal candidiasis the daily dose of the drug is 50-100 mg, the course of treatment is 7-14 days or more (in the presence of immunodeficiency states).
With the development oral candidiasis against the background of wearing dentures, Mikosist is prescribed at a dose of 50 mg / day in combination with local antiseptic therapy for 14 days.
In case of candidiasis of the mucous membranes of other localization (but not genital), for example, in esophagitis, non-invasive bronchopulmonary infections, candiduria, and also candidiasis of the skin the drug is prescribed in a daily dose of 50-100 mg. The course of treatment is 14-30 days.
With vaginal candidiasis Mycosyst is prescribed once in a dose of 150 mg.
With frequent relapses of chronic vaginal candidiasis the drug is prescribed 150 mg 1 time per month for 4-12 months. If necessary, the frequency of use of the drug can be increased.
When preventing the recurrence of candidiasis in patients with reduced immunity, the daily dose of Mycosyst is 50-400 mg.
With candidiasis of the skin and dermatophytosis the drug is prescribed in a dose of 150 mg 1 time per week or 50 mg / day. The course of treatment is 2-4 weeks, with mycosis stop - up to 6 weeks.
With pityriasis versicolor Mycosyst appoint 50 mg / day for 2-4 weeks.
With onychomycosis the drug is prescribed 150 mg 1 time per week. The course of treatment continues until complete replacement of the affected nail with a healthy one and is 3-6 months with the nails on the fingers and 6-12 months with the nails on the toes. With a long course of the pathological process, a change in the shape of the nail plate may be noted.
With deep endemic mycoses Mycosyst is prescribed in a dose of 200-400 mg / day for 1-2 years.
For children Mycosyst is prescribed daily 1 time / day in a dose not exceeding the daily dose of the drug for adults.The duration of the course of treatment depends on the clinical effect and the normalization of laboratory parameters.
With candidiasis of the mucous membranes Mycosyst is prescribed at a dose of 6 mg / kg on the 1st day of treatment (in order to achieve the required concentration of the drug in the blood plasma), then - 3 mg / kg / day.
In chronic generalized (granulomatous) candidiasis, candidemia, visceral candidiasis, cryptococcosis The daily dose of Mycosyst is 6-12 mg / kg of body weight, depending on the patient's condition.
For the prevention of mycoses in patients with impaired immune systems during the use of cytostatics or radiation therapy, the drug is prescribed in a dose of 3-12 mg / kg body weight / day under the control of the content of neutrophil granulocytes in peripheral blood.
Newborns under 4 weeks Mikosist prescribed in the same dose as older children, but increase the intervals between the introduction of the drug: at under 2 weeks Mycosyst is administered every 72 hours ages 2 to 4 weeks - every 48 hours
Elderly patients in normal renal function, dose adjustment is not required.
For adults at renal dysfunction with a single use of the drug (for example, with vaginal candidiasis) dose adjustment is not required.
In the course of treatment, the first loading dose is 50-400 mg. Then the dose of the drug or the frequency of use must be adjusted depending on the CC.
In children and elderly patients at renal dysfunction correction of the dose of the drug in accordance with the indicators of QC.

Mycosyst is prescribed by mouth or intravenous drip. The rate of administration of the drug is not more than 10 ml / min. If you change the method of administration Mikosist dose adjustment of the drug is not required.

Adverse reactions

Gastrointestinal: nausea, abdominal pain, flatulence, diarrhea.
Allergic reactions: skin rash; rarely - Stevens-Johnson syndrome, Lyell's syndrome; in rare cases - anaphylactic shock.
Other: headache.
It should be borne in mind that against the background of the use of fluconazole in patients with impaired immunity (with tumors, AIDS), the function of the blood-forming organs, liver and kidneys may be impaired, however, at present, their relationship with fluconazole has not been proven.
In patients with AIDS treated with fluconazole, convulsions, leukopenia, thrombocytopenia and alopecia were noted, however, in these cases, the relationship with taking the drug has not been established.

The use of Mikosista during pregnancy is possible only in cases of severe, life-threatening infections, when the expected benefit to the mother outweighs the potential risk to the fetus.
Fluconazole is excreted in breast milk. Therefore, if necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Caution should be exercised when applying Mikosist with cisapride, astemizole, rifabutin, tacrolimus, as well as with other drugs, the metabolism of which is carried out with the participation of the cytochrome P system₄₅₀.
With the development of exudative erythema multiforme, bullous eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), the drug should be stopped.
Patients who have experienced changes in liver function indicators during treatment with Mikosist need to be examined to identify possible hepatotoxic effects.
With the development of symptoms of abnormal liver function, treatment with Mikosist should be stopped.
100 ml of infusion solution contain 15 mmol of sodium and chlorine ions, which should be considered when prescribing the drug to patients who need to limit sodium and fluid intake.

Treatment: gastric lavage is shown, then symptomatic therapy is carried out. With forced diuresis, excretion of fluconazole is enhanced. With a three-hour hemodialysis, the concentration of fluconazole in the blood plasma is reduced by 50%.

No clinically significant interaction of Mycosyst with oral contraceptives was noted.
With the simultaneous use of Mikosista with coumarin anticoagulants, an increase in prothrombin time is possible.
With the simultaneous appointment of Mikosist with terfenadine, one should consider the risk of developing cardiac arrhythmias (therefore, when prescribing this combination, medical monitoring of the patient's condition should be carried out).
With simultaneous use with cisapride, a heart rhythm disturbance (including paroxysmal ventricular tachycardia) is possible.
Pharmacokinetic interaction
With simultaneous use with oral hypoglycemic drugs (sulfonylurea derivatives), the half-life of the latter and the risk of hypoglycemia may increase.
With the simultaneous use of Mikosist and phenytoin, an increase in the concentration of the latter in the blood plasma is noted.
With the simultaneous use of Mikosist with rifampicin, a more rapid excretion of fluconazole from blood plasma (by 20%) is noted, which requires an increase in the dose of the latter.
With the simultaneous use of Mikosist with cyclosporin A, it is possible to increase the concentration of the latter (therefore, when prescribing this combination, it is necessary to control the concentration of cyclosporin A in the blood plasma).
With the simultaneous use of Mikosist with theophylline, it is possible to increase the concentration of the latter in the blood (therefore, when prescribing this combination, it is necessary to reduce the dose of theophylline).
With the simultaneous use of Mikosist with zidovudine, it is possible to increase the concentration of the latter in the blood plasma, which may require correction of its dose.
With the simultaneous use of Mikosist with rifabutin, it is possible to increase the level of the latter in the blood plasma and in some cases the development of uveitis.
The simultaneous administration of antacids, cimetidine and mycosyst does not affect the absorption of fluconazole.
Pharmaceutical Interaction
Mikosist in the form of solution for infusions is compatible with 20% glucose solution, Ringer's solution, potassium chloride solution in glucose, 4.2% sodium bicarbonate solution, Hartmann solution, aminofusin, 0.9% sodium chloride solution (can be added in one infusion system).

The drug should be stored at a temperature of 15 ° to 30 ° C.

capsules - 2 years, solution for infusions - 1 year.
Pharmacy sales terms
The drug in the form of capsules is approved for use as a means of non-prescription.
The drug in the form of an infusion solution is dispensed with a prescription.