Flucostat 150mg capsules 1
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Active substance: fluconazole 150 mg;
Excipients: lactose, corn starch, silicon dioxide, magnesium stearate, sodium sulfate.
Antifungal drug. Fluconazole - a representative of the class of triazole antifungal agents, is a powerful selective inhibitor of sterol synthesis in the fungal cell.
It is active against pathogens of opportunistic mycoses, including those caused by Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Fluconazole activity has also been shown in models of endemic mycoses, including infections caused by Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum.
Indications for use
- cryptococcosis, including cryptococcal meningitis and other localizations 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;
- generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infection (including infections of the peritoneum, endocardium, eyes, respiratory and urinary tract). Treatment can be carried out in patients with malignant neoplasms, patients of intensive care units, patients receiving cytotoxic or immunosuppressive drugs, as well as in the presence of other factors predisposing to the development of candidiasis;
- candidiasis of the mucous membranes, including the oral cavity and pharynx (including atrophic candidiasis of the oral cavity associated with the wearing of dentures), esophagus, non-invasive bronchopulmonary infections, candiduria; relapse prevention oropharyngeal candidiasis in AIDS patients;
- genital candidiasis: treatment of vaginal candidiasis (acute and chronic recurrent), prophylactic use to reduce the recurrence rate of vaginal candidiasis (3 or more episodes per year); candidal balanitis;
- prevention of fungal infections in patients with malignant neoplasms who are predisposed to such infections as a result of cytotoxic chemotherapy or radiation therapy;
- mycoses of the skin, including mycoses of the feet, body, groin area, pityriasis versi, onychomycosis and candidiasis of the skin;
- deep endemic mycoses, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.
- simultaneous administration of drugs that prolong the QT interval (including terfenadine or astemizole);
- children's age up to 3 years;
- hypersensitivity to the drug or similar in structure to azol compounds.
With caution, the drug should be used for hepatic and / or renal failure, simultaneously with taking potentially dangerous hepatotoxic drugs, with alcoholism, in the case of proarrhythmogenic conditions in patients with multiple risk factors (organic heart disease, electrolyte imbalance, simultaneous administration of drugs that cause arrhythmias).
Use in pregnancy and lactation
The use of Flucostate during pregnancy is possible only in the case of severe and potentially life-threatening fungal infections, when the expected benefit of treatment exceeds the possible risk to the fetus.
Since fluconazole is excreted in breast milk in concentrations close to plasma concentrations, it is not recommended to prescribe the drug during breastfeeding.
Use in impaired liver function
With caution, the drug should be used for liver failure, simultaneously with taking potentially dangerous hepatotoxic drugs, with alcoholism.
When clinical signs of liver damage appear, which may be associated with fluconazole, the drug should be discontinued.
Use in renal dysfunction
Patients with renal insufficiency (CK<50 ml / min) require correction of the dosage regimen.
Fluconazole is excreted mainly in the urine unchanged. With a single dose, a dose change is not required. In patients (including children and the elderly) with impaired renal function when re-taking the drug, a shock dose of 50 mg to 400 mg should initially be administered.
With CK>50 ml / min, the average recommended dose of the drug is used; with AQ of 11 to 50 ml / min, a dose of 50% of the recommended dose is used. Patients, regularly those on hemodialysis, one dose of the drug is administered after each hemodialysis session.
Use in children
Contraindication: children under 3 years of age.
Use in elderly patients
In elderly patients in the absence of impaired renal function, the drug is used in accordance with the usual dosing regimen.
In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, including fatal outcome, mainly in patients with serious concomitant diseases. There was no obvious dependence of the frequency of development 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; signs of it disappeared after discontinuation of therapy. When clinical signs of liver damage appear, which may be associated with fluconazole, the drug should be discontinued.
AIDS patients more are prone to the development of severe skin reactions when using many drugs. If a patient receiving treatment for a superficial fungal infection appears, a rash that can be associated with the intake of fluconazole, 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 bullous lesions or erythema multiforme appear.
Caution should be exercised when simultaneously using fluconazole with cisapride, astemizole, rifabutin, tacrolimus or other drugs metabolized by isoenzymes of the cytochrome P450 system.
Dosage and Administration
For cryptococcal infections, candidemia, disseminated candidiasis and other invasive candidiasis infections: on the 1st day - 400 mg, then - 200-400 mg 1 time per day.
For the prevention of recurrence of cryptococcal meningitis in AIDS patients after complete course of primary treatment: 200 mg / day for a long period.
With atrophic oral candidiasis associated with the wearing of dentures: 50 mg 1 time per day for 10-14 days.
For other candidal infections of the mucous membranes: 50-100 mg / day for 14-30 days.
For the prevention of recurrence of oropharyngeal candidiasis in AIDS patients after completing the full course of primary treatment: 150 mg 1 time per week.
With vaginal candidiasis and balanitis: once 150 mg. For the prevention of relapse - 150 mg 1 time per month, for 4-12 months.
For the prevention of candidiasis in cancer patients during cytostatic chemo- or radiation therapy: 50-400 mg 1 time per day. If there is a high risk of developing a generalized infection: 400 mg 1 time per day for a few days before the expected appearance of neutropenia; after increasing the number of neutrophils more than 1000/ mm 3 treatment is continued for another 7 days.
With mycoses of the skin (feet, inguinal region, etc.), incl. candidal infections: 150 mg 1 time per week or 50 mg 1 time per day. The duration of therapy is 2-4 weeks, with mycoses of the feet - up to 6 weeks.
With pityriasis versiwisch: 50 mg 1 time per day for 2-4 weeks.
With onychomycosis: 150 mg 1 time per week until the growth of an uninfected nail (3-6 and 6-12 months for finger and toe nails, respectively).
With deep endemic mycoses: 200-400 mg / day for 11-24 months (coccidioidomycosis), 2-17 months (paracoccidiomycosis), 1-16 months (sporotrichosis), 3-17 months (histoplasmosis).
Children with candidiasis of the mucous membranes on the 1st day - 6 mg / kg / day, then - 3 mg / kg / day, with systemic candidiasis or cryptococcosis - 6-12 mg / kg, depending on the severity of the disease. For prevention against the background of reduced immunity (depending on the severity of neutropenia) - 3-12 mg / kg / day.
Symptoms: hallucinations, paranoid behaviour.
Treatment: Gastric lavage and symptomatic therapy are recommended. Since fluconazole is excreted in the urine, forced diuresis increases its excretion. Hemodialysis for 3 hours reduces the concentration of fluconazole in the plasma by about 50%.
From the digestive system: change in taste, nausea, flatulence, vomiting, abdominal pain, diarrhea; rarely - violations of liver function (jaundice, hepatitis, hepatonecrosis, hyperbilirubinemia, increased activity of ALT, AST, ALP).
From the side of the central nervous system: headache, dizziness; rarely - convulsions.
From the hematopoietic system: rarely - leukopenia, thrombocytopenia, agranulocytosis.
From the cardiovascular system: an increase in the duration of the QT interval, flickering, fluttering of the ventricles.
Allergic reactions: skin rash; rarely - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactoid reactions.
From the side of metabolism: rarely - hypercholesterolemia, hypertriglyceridemia, hypokalemia.
Other: rarely - impaired renal function, alopecia.
In a dry place, at a temperature of 15 ° to 25 ° C.
Shelf life: 2 years. Keep out of reach of children.
- Dosage form
- 150 mg
- Number of tablets
- INN Russian
- Russian title