Mikosist - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Mycosist

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 261 rubles.

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Mycosist is a drug with antifungal action.

Release form and composition

Mikosist is available in two dosage forms:

• Solution for infusion: transparent, colorless or slightly colored (100 ml in vials, 1 vial in a cardboard box);
• Capsules: hard, gelatinous, with an opaque white body (L500), filled inside with an almost white or white powder or a powdery dense mass; 50 mg each - size No. 4, with a light blue opaque lid (L910) (7 pcs. in blisters, 1 blister in a cardboard box); 100 mg each - size No. 2, with a turquoise opaque lid (L890) (7 pcs. in blisters, 1 or 4 blisters in a cardboard box); 150 mg - size No. 1, with a blue opaque lid (L860) (1 pc. in blisters, 1, 2 or 4 blisters in a cardboard box).

1 capsule contains:

• Active ingredient: fluconazole - 50/100/150 mg;
• Auxiliary components (capsules of 50/100/150 mg, respectively): magnesium stearate - 1.2 / 2.4 / 3.6 mg, povidone - 3.6 / 7.2 / 10.8 mg, anhydrous lactose - 49, 5/99 / 148.5 mg, corn starch - 12.1 / 24.2 / 36.3 mg, talc - 3.3 / 6.6 / 9.9 mg, colloidal silicon dioxide - 0.3 / 0, 6 / 0.9 mg;
• Cap (capsules of 50/100/150 mg, respectively): titanium dioxide (E171, CI77891) - 4/4 / 1.5%, indigo carmine (E132, CI73015) - 0.0086 / 0.0471 / 0.2513%, gelatin - up to 100% (for all types of capsules);
• Body (capsules of 50/100/150 mg, respectively): titanium dioxide (E171, CI77891) - 2/2/2%, gelatin - up to 100% (for all types of capsules).

The composition of 10 ml solution for infusion includes:

• Active ingredient: fluconazole - 20 mg;
• Auxiliary components: sodium chloride - 90 mg, water for injection - up to 10 ml.

Indications for use

• Generalized candidiasis: candidemia, disseminated candidiasis and other forms of invasive candidiasis infections (infections of the eyes, endocardium, abdominal cavity, urinary and respiratory tract), including in patients receiving a course of cytostatic or immunosuppressive therapy, as well as in the presence of other factors predisposing to the development of candidiasis (with therapeutic and prophylactic purposes);
• Cryptococcosis: cryptococcal infections of the skin and lungs, cryptococcal sepsis and meningitis, cryptococcosis with acquired immunodeficiency syndrome (in order to prevent relapses); with organ transplantation or other cases of immunodeficiency;
• Candidiasis of the mucous membranes, incl. candidiasis of the esophagus, pharynx, oral cavity (including atrophic candidiasis associated with wearing dentures), as well as candiduria, non-invasive bronchopulmonary infections;
• Genital candidiasis: vaginal (chronic recurrent or acute form); candidal balanitis (capsules);
• Fungal infections in patients with malignant neoplasms predisposed to the development of such infections due to chemotherapy with cytostatics or radiation therapy; oropharyngeal candidiasis in patients with AIDS (for prophylaxis);
• Mycoses of the skin, including mycoses of the groin and trunk;
• Deep endemic mycoses, including coccidioidosis, histoplasmosis and paracoccidioidosis in patients with normal immunity;
• Onychomycosis, mycoses of the feet, pityriasis versicolor (capsules).

Contraindications

Absolute:

• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• Simultaneous use with terfenadine (with constant intake of Mikosist in a daily dose of 400 mg), cisapride (drugs increase the risk of severe heart rhythm disturbances and lengthen the QT interval);
• Simultaneous use with astemizole;
• Breastfeeding period;
• Hypersensitivity to the components of the drug or to other structurally similar azole compounds.

Relative (Mikosist should be used with caution in the following diseases / conditions):

• Hepatic and / or renal failure;
• Rash when taking the drug in patients with systemic and / or invasive fungal infections and superficial fungal diseases;
• Potentially proarrhythmogenic conditions in patients with multiple risk factors, including electrolyte imbalance, organic heart disease, simultaneous use with drugs that cause arrhythmias;
• Acetylsalicylic acid intolerance;
• Simultaneous use with terfenadine (with a daily dose of fluconazole up to 400 mg);
• Simultaneous use with rifabutin or other drugs that are metabolized with the participation of the cytochrome P450 system;
• Pregnancy.

Method of administration and dosage

Mikosist in the form of a solution for infusion is injected intravenously at a rate of no more than 20 mg (10 ml) per minute; capsules should be taken orally.

It is not necessary to adjust the daily doses when switching from one dosage form to another.

Adults are advised to use the following dosing regimen:

• Disseminated candidiasis, candidemia and other invasive infections caused by Candida fungi: on the first day - in a daily dose of 400 mg, then - 200 mg per day. If necessary, the dose is doubled, in severe systemic candidiasis - up to 800 mg per day. The duration of the course depends on the clinical efficacy of the drug, while the use of Mikosist must be continued for at least 14 days after the symptoms of the disease disappear or upon confirmation of a negative blood culture;
• Cryptococcal infections: on the first day - in a daily dose of 400 mg, then - once a day, 200-400 mg. The duration of the course is determined by the clinical efficacy confirmed by the results of mycological studies. Most often, therapy is carried out from 6 weeks to 2 months. In the treatment of cryptococcal meningitis, a longer use of Mikosist is indicated - from 10 weeks to 2 months after a negative result of a microbiological study of a cerebrospinal fluid sample. At the end of the full course of primary therapy in order to prevent the recurrence of cryptococcal meningitis, patients with AIDS are advised to use Mikosist for a long time, 200 mg per day;
• Atrophic oral candidiasis associated with dentures: 14 days at a daily dose of 50 mg. Therapy should be combined with the use of antiseptic agents for the treatment of the prosthesis;
• Oropharyngeal candidiasis, including patients with impaired immunity: 7-14 days at a daily dose of 50-100 mg. For the prevention of patients with AIDS, after completing the full course of primary therapy, Mikosist is prescribed 150 mg 1 time in 7 days. If necessary (especially in severe immunity disorders), the duration of treatment is increased;
• Other candidiasis infections (candiduria, esophagitis, non-invasive bronchopulmonary infections, candidiasis of the skin and mucous membranes): 14-30 days at a daily dose of 50-100 mg;
• Vaginal candidiasis: 150 mg once. To reduce the frequency of relapses, Mikosist in the same dose should be taken once a month for 4-12 months, in some cases, more frequent use is possible;
• Severe candidiasis of the mucous membranes: 100-200 mg per day;
• Balanitis caused by Candida spp.: once 150 mg of Mycosist in capsule form;
• Prevention of candidiasis: the daily dose is determined by the degree of risk of developing a fungal infection and can vary from 50 to 400 mg. If there is a high risk of generalized infection (for example, patients with long-term or expected severe neutropenia), Mikosist is prescribed 400 mg per day. The drug should be started several days before the expected development of neutropenia, after an increase in the number of neutrophils more than 1000 / mm³, therapy should be continued for another 7 days;
• Fungal infections in patients with malignant neoplasms (prevention): the drug in a daily dose of 50 mg must be taken as long as the patient is at increased risk due to cytostatic or radiation therapy;
• Pityriasis versicolor: 2 doses of 300 mg Mikosist in the form of capsules, 7 days apart. In some cases, it may be necessary to take a third dose - 300 mg with the same break, but often a single dose of 300 mg is sufficient. As an alternative treatment regimen, a daily intake of 50 mg of Mikosist per day is possible for 2 weeks to 1 month;
• Mycoses of the skin (including candidiasis), including mycoses of the groin area, feet: 50 mg per day or once every 7 days, 150 mg of the drug in the form of capsules. As a rule, the duration of therapy varies within 7-14 days, however, when treating mycoses of the feet, it can be increased to 42 days;
• Deep endemic mycoses: 200-400 mg per day for 2 years. The duration of the therapeutic course is determined individually: paracoccidioidosis - 2-17 months, coccidioidosis - 11-24 months, histoplasmosis - 3-17 months;
• Onychomycosis: 150 mg of Mycosist in capsule form once every 7 days. The drug should be continued until the healthy nail completely replaces the infected one. Most often, for re-growth of nails on the fingers and toes, it is required to continue taking the drug for 3 to 6 and 6 to 12 months, respectively.

In children, the duration of therapy is determined by the clinical and mycological effect. The daily dose for this age category of patients should not exceed that in adults. Mikosist should be used daily 1 time per day.

Children are advised to observe the following dosing regimen:

• Cryptococcal infection and generalized candidiasis: 6-12 mg / kg per day (determined by the severity of the disease);
• Mucosal candidiasis: 3 mg / kg per day. It is allowed to prescribe a loading dose of Mikosist (2 times more than usual) on the first day of treatment;
• Fungal infections in children with reduced immunity, in whom the risk of developing an infection is associated with neutropenia arising from cytotoxic chemotherapy or radiation therapy (prophylaxis): 3-12 mg / kg per day (depending on the duration of preservation and the severity of induced neutropenia) …

In newborns, fluconazole is excreted more slowly, therefore, in the first 14 days of life, Mikosist should be used in the same dose (in mg per 1 kg of body weight) as in older children, while increasing the interval between drug administration to 72 hours. For children 3-4 weeks of life, the drug is prescribed with a break of 48 hours.

Elderly patients in the absence of functional impairment of the kidneys do not need to adjust the dosage regimen of Mikosist.

Patients with renal insufficiency with a single use of the drug do not require dose adjustment. For a course appointment, a loading dose (from 50 to 400 mg) should initially be used, then the daily dose should be adjusted as follows (frequency of use - 1 time per day):

• Creatinine clearance more than 50 ml per minute: 100% of the recommended (according to indications) dose;
• Creatinine clearance less than 50 ml per minute (without dialysis): 50% of the recommended (as indicated) dose.

Patients on continuous dialysis are prescribed 100% of the recommended dose after each session.

The solution for infusion is compatible with sodium chloride solution, sodium bicarbonate (0.9%), potassium chloride in glucose, Hartman's, Ringer's solutions and 20% glucose solution. Fluconazole can be infused using one of the solutions listed above using conventional transfusion kits.

Side effects

When using Mikosist, disturbances from some body systems may develop:

• Nervous system: dizziness, convulsions, headache;
• Digestive system: abdominal pain, diarrhea, flatulence, liver dysfunction (hepatocellular necrosis, including fatal ones, jaundice, hepatitis, hyperbilirubinemia, increased activity of alkaline phosphatase, hepatic transaminases), taste change, nausea, vomiting;
• Cardiovascular system: flutter and / or fibrillation of the ventricles, an increase in the duration of the QT interval on the electrocardiogram;
• Metabolism: hypertriglyceridemia, hypokalemia, hypercholesterolemia;
• Hematopoietic organs: agranulocytosis, thrombocytopenia, neutropenia, leukopenia;
• Allergic reactions: exudative erythema multiforme (including Stevens-Johnson syndrome), bronchial asthma (in most cases with intolerance to acetylsalicylic acid), anaphylactoid reactions (including facial edema, itching of the skin, urticaria, angioedema), Lyell's syndrome, skin rash;
• Others: alopecia, functional disorders of the kidneys.

special instructions

Treatment should be carried out before the onset of clinical and hematological remission, since premature termination of the use of Mikosist can lead to the development of relapses.

In rare cases, the use of fluconazole was accompanied by manifestations of toxic effects on the liver (including death), most often in patients with serious concomitant diseases. In this regard, during the use of Mikosist, it is necessary to monitor the liver function, and if signs of its damage appear, which may be associated with taking the drug, therapy should be canceled.

During treatment, in rare cases, the development of exfoliative skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) was noted. Patients with malignant neoplasms and AIDS are more likely to develop severe skin reactions.

If during the period of treatment in patients with a superficial fungal infection, a rash occurs, which can be associated with taking Mikosist, therapy should be canceled. Patients with systemic invasive fungal infections require particularly careful monitoring of rash.

With the development of erythema multiforme or bullous lesions, the drug is canceled.

With simultaneous therapy with indirect anticoagulants of the coumarin series, it is recommended to control the prothrombin time.

Since Mikosist can cause dizziness, during treatment, patients need to be careful when performing potentially hazardous types of work that require fast psychomotor reactions and increased attention, including driving.

Drug interactions

With the simultaneous use of Mikosist with some drugs, the following effects may occur (T _1/2 - the half-life of the substance; C _max - the maximum concentration of the drug in the blood):

• Zidovudine: an increase in its concentration in blood plasma and the likelihood of side effects;
• Sulfonylurea preparations: lengthening their T _1/2, and therefore, when using this combination of drugs, one should take into account the possibility of hypoglycemia;
• Tacrolimus: an increase in its concentration in blood serum and the risk of developing nephrotoxicity;
• Theophylline: a decrease in the average rate of its clearance from blood plasma, an increase in the risk of developing its toxic effect and overdose;
• Phenytoin: a clinically significant increase in its concentration (dose adjustment may be required);
• Rifampicin: decrease in its C _max and T _1/2 (dose adjustment of fluconazole may be required);
• Midazolam: a significant increase in its concentration in blood plasma and the risk of developing psychomotor reactions;
• Rifabutin: an increase in its serum concentration, the likelihood of developing uveitis;
• Cyclosporine: an increase in its concentration in the blood;
• Hydrochlorothiazide: increasing the concentration of fluconazole in blood plasma.

With the simultaneous use of Mikosist with other drugs metabolized by the cytochrome P450 system, care must be taken.

Analogs

The analogues of Mikosist are: Diflucan, Medoflucon, Mikoflucan, Mikomax, Flucostat, Fluconazole, Fluconazole-Teva, Flucorus, Flucomabol, Flucosan.

Terms and conditions of storage

Keep out of reach of children at temperatures up to 30 ° C.

Shelf life:

• Solution for infusion - 2 years;
• Capsules - 5 years.

Terms of dispensing from pharmacies

Capsules are available without a prescription, and infusion solutions are available with a prescription.

Mikosist: prices in online pharmacies

Drug name Price Pharmacy

Mikosist 150 mg capsule 1 pc. 261 r Buy

Mycosyst capsules 150mg 302 RUB Buy

Mikosist 150 mg capsules 2 pcs. 482 r Buy

Mikosist 50 mg capsule 7 pcs. RUB 485 Buy

Mycosyst capsules 50mg 7 pcs. RUB 539 Buy

Mycosist capsules 150mg 4 pcs. RUB 600 Buy

Mikosist 150 mg capsules 4 pcs. RUB 600 Buy

Mikosist 100 mg capsule 28 pcs. 1899 RUB Buy

Mycosist capsules 100mg 28 pcs. 1945 RUB Buy

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!