MIKOSIST CAPSULES 150MG

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MIKOSIST CAPSULES 150MG - 4PCS

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Mycosyst capsules

Latin name

Mycosyst

Release form

capsules

Active ingredient

1 capsule contains:

- Active substances
- Fluconazole 150 mg.

- Auxiliary substances Silicon colloidal dioxide, Magnesium stearate, talc, Povidone K30, corn starch, anhydrous lactose.

- The composition of hard gelatin capsules Titanium dioxide (C.I.77891 / E171), indigo carmine (C.I.73015 / E132), gelatin.

Pharmacology

Mikosist - antifungal medication.

Fluconazole, a member of the class of triazole antifungal agents, is a potent selective inhibitor of sterol synthesis in the cell of fungi.

Active against pathogens of opportunistic mycoses, incl. caused by:

- Candida spp.
- Cryptococcus neoformans.
- Microsporum spp.
- Trichophyton spp.

Fluconazole activity is also shown on models of endemic mycoses, including infections caused by:

- Blastomyces dermatitidis.
- Coccidioides immitis.
- Histoplasma capsulatum.

Indications

- Cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with a normal immune response and in patients with various forms of immunosuppression (including AIDS patients, organ transplantation ); The drug can be used to prevent cryptococcal infection in AIDS patients and in organ transplantation.
- Generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infection (including infections of the peritoneum, endocardium, eyes, respiratory and urinary tract). Treatment may be carried out in patients with malignant neoplasms, patients in intensive care units, patients receiving cytotoxic or immunosuppressive agents, as well as in the presence of other factors predisposing to the development of candidiasis.
- Candidiasis of mucous membranes, incl. oral cavity and pharynx (including atrophic candidiasis of the oral cavity associated with the wearing of dentures), esophagus, non-invasive bronchopulmonary infections, candiduria, candidiasis of the skin; prevention of recurrent oropharyngeal candidiasis in AIDS patients.
- Genital candidiasis: vaginal candidiasis (acute and chronic recurrent), prophylactic use in order to reduce the frequency of recurrences of vaginal candidiasis (3 or more episodes per year); candidal balanitis.
- Prevention of fungal infections in patients with malignant tumors that are predisposed to such infections as a result of cytotoxic Chemotherapy or radiation therapy.
- Mycoses of the skin, including mycoses of the feet, body, inguinal region, pityriasis versicolor, onychomycosis and skin candidiasis.
- Deep endemic mycoses, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.

Contraindications

- Simultaneous use of terfenadine or astemizole and other drugs that extend the QT interval.
- Children's age up to 6 months (for oral administration).
- Hypersensitivity to the drug or similar in structure azole compounds.

Pregnanacy and breastfeeding

The use of the drug Mikosist during pregnancy is impractical, with the exception of severe or life-threatening forms of fungal infections, if the intended benefit to the mother outweighs the possible risk to the fetus.

Fluconazole is found in breast milk in the same concentration as in plasma, so its administration during lactation is not recommended.

Dosage and administration

- Use in adults
- With cryptococcal infections
- For cryptococcal meningitis and cryptococcal infections of other localization, 400 mg is prescribed on the first day, and then continue treatment at a dose of 200-400 mg 1 time / day. The duration of treatment of cryptococcal infections depends on the clinical efficacy confirmed by mycological examination; with cryptococcal meningitis, the therapy is usually continued for at least 6-8 weeks.
- To prevent the recurrence of cryptococcal meningitis in AIDS patients, after completing the full course of primary treatment, therapy with fluconazole at a dose of 200 mg / day can be continued for a very long time.

- With candidal infections
- With candidemia, disseminated candidiasis and other invasive candidal infections, the dose averages 400 mg on the first day, and then 200 mg / day. With insufficient clinical efficacy, the dose may be increased to 400 mg / day. The duration of therapy depends on the clinical effectiveness.
- With oropharyngeal candidiasis, the drug is prescribed on average 50-100 mg 1 time / day; the duration of therapy is 7-14 days. If necessary, in patients with a pronounced decrease in immunity, treatment may be longer.
- In case of atrophic oral candidiasis associated with the wearing of dentures, the drug is prescribed in an average dose of 50 mg 1 time / day for 14 days in combination with local antiseptic agents for the treatment of the prosthesis.
- For other candidal infections of the mucous membranes (except for genital candidiasis), for example, esophagitis, non-invasive bronchopulmonary lesions, candiduria, candidiasis of the skin and mucous membranes, the effective dose is on average 50-100 mg / day for a duration of treatment of 14-30 days.
- For the prevention of recurrence of oropharyngeal candidiasis in AIDS patients after completing the full course of primary therapy, fluconazole may be prescribed 150 mg 1 time / week.
- In vaginal candidiasis, fluconazole is taken once orally at a dose of 150 mg. To reduce the frequency of recurrences of vaginal candidiasis, the drug can be used at a dose of 150 mg 1 time / month. The duration of therapy is determined individually; it varies from 4 to 12 months. Some patients may need more frequent use.
- When balanitis caused by Candida, fluconazole is administered once at a dose of 150 mg orally.
- For the prevention of candidiasis, the recommended dose of fluconazole is 50-400 mg 1 time / day, depending on the degree of risk of developing a fungal infection. If there is a high risk of generalized infection, for example, in patients with expected severe or prolonged neutropenia, the recommended dose is 400 mg 1 time / day. Fluconazole is prescribed a few days before the expected appearance of neutropenia; after an increase in the number of neutrophils of more than 1000 / μl, the treatment is continued for another 7 days.

- For mycoses of the skin, including mycoses of the feet, smooth skin, inguinal area and skin candidiasis. For mycoses of the skin, including mycoses of the feet, smooth skin, inguinal region and skin candidiasis, the recommended dose is 150 mg 1 time / week or 50 mg 1 time / day. The duration of therapy in normal cases is 2-4 weeks, however, with mycoses of the feet, longer therapy may be required (up to 6 weeks).

- With pithya. With pithya., The recommended dose is 300 mg 1 time / week. within 2 weeks; some patients require a third dose of 300 mg / week, while in some cases a single dose of 300-400 mg is sufficient. An alternative treatment regimen is the use of the drug 50 mg 1 time / day for 2-4 weeks.

- With onychomycosis With onychomycosis, the recommended dose is 150 mg 1 time / week. Treatment should be continued until the infected nail is replaced (the uninfected nail grows). Normally, it takes 3-6 months and 6-12 months, respectively, to re-grow nails on the fingers and feet.

- With deep endemic mycoses With deep endemic mycoses, you may need to use the drug in a dose of 200-400 mg / day for up to 2 years. The duration of therapy is determined individually; it is 11–24 months for coccidioidomycosis, 2–17 months for paracoccidiomycosis, 1–16 months for sporotrichosis and 3–17 months for histoplasmosis.

- Use in children In children, as with similar infections in adults, the duration of treatment depends on the clinical and mycological effect. In children, the drug should not be used in a daily dose in excess of that in adults. The drug is used daily 1 time / day.
- For the treatment of generalized candidiasis and cryptococcal infection, the recommended dose is 6-12 mg / kg / day, depending on the severity of the disease.
- For the prevention of fungal infections in children with reduced immunity, in whom the risk of developing an infection is associated with neutropenia developing as a result of cytotoxic chemotherapy or radiation therapy, the drug is prescribed at 3-12 mg / kg / day, depending on the severity and duration of preservation of induced neutropenia.
- In case of candidiasis of the mucous membranes, the recommended dose of fluconazole is 3 mg / kg / day. On the first day, a loading dose of 6 mg / kg can be given in order to more quickly achieve constant equilibrium concentrations.

- Use in children with impaired renal function In children with impaired renal function, the daily dose of the drug should be reduced (in the same proportion as in adults) in accordance with the severity of renal failure.

- Use in elderly patients In elderly patients in the absence of signs of renal failure, the usual dosing regimen should be followed.

- Use in violation of renal function. Patients with renal insufficiency (creatinine clearance (CK) <50 ml / min) require correction of the dosage regimen. Fluconazole is excreted mainly in the urine unchanged. When taken once a dose change is not required. When reappointment to patients with impaired renal function, you should enter the loading dose from 50 mg to 400 mg. When QA> 50 ml / min, the average recommended dose of the drug is used; with QA from 11 to 50 ml / min, a dose of 50% of the recommended dose is applied.Patients who are regularly on hemodialysis, a single dose of the drug is administered after each hemodialysis session.

special instructions

AIDS patients are more likely to develop severe skin reactions with the use of many drugs. When a rash appears to be associated with fluconazole in a patient receiving treatment for a superficial fungal infection, the drug should be discontinued. When a rash appears in patients with invasive / systemic fungal infections, they should be carefully monitored and fluconazole should be canceled when there is a bullous lesion or erythema multiforme.

Care must be taken with simultaneous use of fluconazole with cisapride, astemizole, rifabutin, tacrolimus, or other drugs metabolized by the cytochrome P 450 system.

- Use in disorders of liver function. In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, including fatal, mainly in patients with serious concomitant diseases. There is no marked dependence of the incidence of hepatotoxic effects of fluconazole on the total daily dose, duration of therapy, sex and age of the patient. The hepatotoxic effect of fluconazole is usually reversible; his symptoms disappeared after cessation of therapy. If clinical signs of liver damage appear that may be associated with fluconazole, the drug should be withdrawn.

- Use in renal dysfunction Patients with renal insufficiency (creatinine clearance (CK) <50 ml / min) require correction of the dosing regimen. Fluconazole is excreted mainly in the urine unchanged. When taken once a dose change is not required. When reappointment to patients with impaired renal function, you should enter the loading dose from 50 mg to 400 mg. When QA> 50 ml / min, the average recommended dose of the drug is used; with QA from 11 to 50 ml / min, a dose of 50% of the recommended dose is applied. Patients who are regularly on hemodialysis, a single dose of the drug is administered after each hemodialysis session.

Drug interaction

When using fluconazole with Warfarin , an increase in prothrombin time was noted by 12%. In this regard, it is recommended to control the prothrombin time in patients receiving Mikosist in combination with coumarin anticoagulants.

With simultaneous use of fluconazole increases T1 / 2 oral hypoglycemic drugs - sulfonylurea derivatives (chlorpropamide, glibenclamide, glipizide and tolbutamide) in healthy volunteers. The joint appointment of fluconazole and oral hypoglycemic drugs is allowed, but it should take into account the possibility of the development of hypoglycemia.

The simultaneous use of fluconazole and phenytoin may be accompanied by an increase in the concentration of phenytoin in a clinically significant degree. If the combined use of two drugs is required, monitoring of the level of phenytoin and the selection of its dose to ensure therapeutic serum concentrations are necessary.

The simultaneous use of fluconazole and rifampicin leads to a 25% decrease in AUC and a shortening of T 1/2 fluconazole by 20%. In patients receiving rifampicin at the same time, it is necessary to consider the feasibility of increasing the dose of fluconazole.

It is recommended to control the concentration of cyclosporine in the blood of patients receiving fluconazole, since with the use of fluconazole and cyclosporine in patients with a transplanted kidney, receiving fluconazole at a dose of 200 mg / day slowly increased the concentration of cyclosporine.

Patients who receive theophylline in high doses, or who are likely to develop theophylline intoxication, should be monitored for the early detection of symptoms of an overdose of theophylline, because simultaneous reception of fluconazole leads to a decrease in the average rate of clearance of theophylline from plasma.

With the simultaneous use of fluconazole and cisapride, cases of adverse reactions to the heart are described, including paroxysmal ventricular tachycardia (arrhythmia of the "pirouette" type).

There are reports of the interaction of fluconazole and rifabutin, accompanied by an increase in serum levels of the latter. With the simultaneous use of fluconazole and rifabutin, cases of development of uveitis are described. It is necessary to carefully observe patients who simultaneously receive rifabutin and fluconazole.

With simultaneous use of zidovudine and fluconazole, there is an increase in plasma zidovudine concentration, which is caused by a decrease in the conversion of the latter to the main metabolite, therefore, an increase in adverse reactions should be expected.

Overdose

- Symptoms: hallucinations, paranoid behavior.
- Treatment: gastric lavage and symptomatic therapy is recommended. Since fluconazole is excreted in the urine, forced diuresis increases its excretion. Hemodialysis for 3 hours reduces plasma concentration of fluconazole by 50%.

Storage conditions

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

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