"Ryativnik ®" capsules are used for:
Treatment of the following diseases in adults: cryptococcal meningitis; coccidioidomycosis; invasive candidiasis; candidiasis of the mucous membranes, including oropharyngeal candidiasis and esophageal candidiasis, candiduria, chronic candidiasis of the skin and mucous membranes; chronic atrophic candidiasis (candidiasis caused by the use of dentures) when local dental hygiene products are ineffective; vaginal candidiasis, acute or recurrent, when local therapy is not appropriate; candidal balanitis, when local therapy is not appropriate; dermatomycoses, including mycoses of the feet, mycoses of smooth skin, inguinal dermatomycosis, lichen multicolor and candidal skin infections, when systemic therapy is not appropriate; Dermatophyte onychomycosis, when the use of other drugs is not appropriate; prevention of such diseases in adults as: recurrence of cryptococcal meningitis in patients with a high risk of its development; recurrence of oropharyngeal or esophageal candidiasis in HIV patients with a high risk of its development; reduction of the frequency of recurrence of vaginal candidiasis (4 or more cases per year); prevention of candidal infections in patients with prolonged neutropenia (for example, patients with malignant blood diseases receiving chemotherapy or patients undergoing hematopoietic stem cell transplantation); treatment of children: candidiasis of the mucous membranes (oropharyngeal candidiasis, esophageal candidiasis), invasive candidiasis, cryptococcal meningitis and for the prevention of candidal infections in patients with reduced immunity (the drug can be used as maintenance therapy to prevent recurrence of cryptococcal meningitis in children with a high risk of its development).
Composition
Active ingredient: fluconazole (one capsule contains fluconazole, calculated as 100% substance 100 mg).
Excipients: calcium stearate, sodium starch glycolate (type A); shell composition: gelatin, patent blue V (E 131), quinoline yellow (E 104), titanium dioxide (E 171), azorubine (E 122), indigo carmine (E 132).
Contraindication
Hypersensitivity to fluconazole, other azole compounds or to any of the excipients of the drug; simultaneous use of fluconazole and terfenadine in patients receiving fluconazole multiple times at doses of 400 mg/day and above (according to the results of a multiple-dose interaction study); simultaneous use of fluconazole and other drugs that prolong the QT interval and are metabolized by the CYP3A4 enzyme (for example, cisapride, astemizole, pimozide, quinidine and erythromycin).
Method of application
The daily dose of fluconazole depends on the type and severity of the fungal infection. For most cases of vaginal candidiasis, a single dose is sufficient.
If repeated use of the drug is necessary, treatment of infections should be continued until the disappearance of clinical and laboratory manifestations of fungal infection activity. Insufficient duration of treatment may lead to the resumption of the active infectious process.
The drug is administered, depending on the dosage form, orally or intravenously by infusion. The method of administration of the drug depends on the clinical condition of the patient. There is no need to change the daily dose of the drug when changing the route of administration from oral to intravenous and vice versa.
The capsules should be swallowed whole. Taking the drug does not depend on food intake.
Adults
Cryptococcosis. Treatment of cryptococcal meningitis: loading dose is 400 mg on the first day. Maintenance dose is 200-400 mg/day. Duration of treatment is usually at least 6-8 weeks. In life-threatening infections, the daily dose can be increased to 800 mg. Maintenance therapy to prevent recurrence of cryptococcal meningitis in patients at high risk of its development: the recommended dose of the drug is 200 mg/day for an unlimited period.
Coccidioidosis. The recommended dose is 200-400 mg/day. The duration of treatment is 11-24 months or longer depending on the patient's condition. For the treatment of some forms of infection, especially for the treatment of meningitis, a dose of 800 mg/day may be appropriate.
Invasive candidiasis. Loading dose is 800 mg on the first day. Maintenance dose is 400 mg/day. The usual recommended duration of treatment for candidemia is two weeks after the first negative blood culture results and resolution of signs and symptoms of candidemia.
Prevention of recurrence of mucosal candidiasis in HIV patients at high risk of developing it. Oropharyngeal candidiasis, esophageal candidiasis: the recommended dose is 100-200 mg/day or 200 mg 3 times a week. The duration of treatment is unlimited for immunocompromised patients.
Prevention of candidal infections in patients with prolonged neutropenia. The recommended dose is 200-400 mg. Treatment should be started a few days before the expected development of neutropenia and continued for 7 days after the neutrophil count increases above 1000 / mm 3.
Genital candidiasis:
Acute vaginal candidiasis, candidal balanitis: the recommended dose is 150 mg once; treatment and prevention of recurrent vaginal candidiasis (4 or more cases per year): the recommended dose is 150 mg once every 3 days. A total of 3 doses should be administered (day 1, day 4 and day 7). After that, a maintenance dose of 150 mg should be administered once a week for 6 months.
dermatomycoses:
athlete's foot, smooth skin mycosis, inguinal dermatomycosis, candidal skin infections: the recommended dose is 150 mg 1 time per week or 50 mg 1 time per day; the duration of treatment is 2-4 weeks (treatment of athlete's foot can last up to 6 weeks); lichen planus: the recommended dose is 300-400 mg 1 time per week for 1-3 weeks; Dermatophyte onychomycosis: the recommended dose is 150 mg 1 time per week. Treatment should be continued until a healthy nail grows in place of the infected nail. It usually takes 3-6 months and 6-12 months, respectively, to grow healthy nails on the fingers and big toes. However, the rate of nail growth in patients may vary and depend on age. After successful treatment of long-term chronic infections, the shape of the nail sometimes remains changed.
Children
The drug in capsule form can be used in this category of patients when children are able to safely swallow a capsule, usually from the age of 5.
The maximum daily dose of 400 mg should not be exceeded.
As with similar infections in adults, the duration of treatment depends on the clinical and mycological response. This drug is used once a day.
Children from 12 years of age. Depending on weight and pubertal development, the doctor should assess which dose of the drug (for adults or for children) is optimal for the patient. Clinical data indicate that children have a higher clearance of fluconazole compared to adults. The use of doses of 100, 200 and 400 mg in adults and doses of 3, 6 and 12 mg/kg in children leads to comparable systemic exposure. The efficacy and safety of the drug for the treatment of genital candidiasis in children have not been established, despite comprehensive data on the use of the drug in children. If there is a need to use the drug in children (from 12 to 17 years), the usual doses for adults should be used.
Children from 5 to 11 years old:
candidiasis of the mucous membranes: the initial dose is 6 mg/kg/day, the maintenance dose is 3 mg/kg/day; the initial dose can be used on the first day in order to achieve equilibrium concentration more quickly; invasive candidiasis, cryptococcal meningitis: the dose of the drug is 6-12 mg/kg/day, depending on the severity of the disease; maintenance therapy to prevent recurrence of cryptococcal meningitis in children with a high risk of its development: the dose of the drug is 6 mg/kg/day, depending on the severity of the disease; prevention of candidiasis in patients with immunodeficiency: the dose of the drug is 3-12 mg/kg/day, depending on the severity and duration of induced neutropenia.
Application features
Pregnant women
Normal doses of fluconazole and short courses of fluconazole should not be used during pregnancy unless clearly necessary. High doses of fluconazole and/or long courses of fluconazole should not be used during pregnancy except for the treatment of potentially life-threatening infections.
Fluconazole passes into breast milk and reaches concentrations lower than in plasma. Breastfeeding can be continued after a single dose of fluconazole, which is 200 mg or less. Breastfeeding is not recommended with repeated use of fluconazole or with the use of high doses of fluconazole.
Drivers
Studies on the effect of the drug on the ability to drive or operate machinery have not been conducted. Patients should be informed of the possibility of dizziness or convulsions while using this drug. If such symptoms develop, it is not recommended to drive or operate machinery.
Overdose
Fluconazole overdose has been reported; hallucinations and paranoid behavior have also been reported.
In case of overdose, symptomatic supportive therapy should be carried out and, if necessary, gastric lavage should be performed.
Fluconazole is largely excreted in the urine; forced diuresis may accelerate drug elimination. A 3-hour hemodialysis session reduces plasma fluconazole levels by approximately 50%.
Side effects
The most commonly (>1/10) reported adverse reactions were: headache, abdominal pain, diarrhea, nausea, vomiting, rash, increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase in the blood.
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 4 years.
