Fluconazole-Health is indicated for the treatment of fungal infections in adults such as:
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 of the oral cavity (candidiasis caused by the use of dentures) when oral hygiene or local therapy is ineffective.
Fluconazole-Health is indicated for the prevention of such diseases in adults as:
Recurrence of cryptococcal meningitis in patients at high risk of developing it; Recurrence of oropharyngeal or oesophageal candidiasis in HIV patients at high risk of developing it; Prevention of candidal infections in patients with prolonged neutropenia (e.g., patients with blood malignancies receiving chemotherapy or patients undergoing haematopoietic stem cell transplantation).
Fluconazole-Health is used in children from birth for the treatment of 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 at high risk of its development.
Drug therapy may be initiated prior to the results of culture and other laboratory tests; once results are available, antibiotic therapy should be adjusted accordingly.
Composition
Active ingredient: fluconazole;
1 capsule contains 200 mg of fluconazole;
Excipients: lactose monohydrate, potato starch; povidone, calcium stearate; capsule shell contains titanium dioxide (E 171), gelatin, black ink (in case of applying the company's trademark - ZT; contains shellac Glaze 45% solution in ethanol, black iron oxide (E172), propylene glycol, concentrated ammonia solution).
Contraindication
Hypersensitivity to fluconazole, to other azole compounds or to any of the excipients of the drug. Concomitant 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). Concomitant use of fluconazole and other drugs that prolong the QT interval and are metabolized by the CYP3A4 enzyme (e.g. cisapride, astemizole, pimozide, quinidine and erythromycin).
Method of application
The dose of fluconazole depends on the type and severity of the fungal infection.
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 should be administered intravenously by infusion. 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 infusion solution should be administered at a rate not exceeding 10 ml/min.
Application features
Pregnant women
An observational study has shown an increased risk of spontaneous abortion in women who received fluconazole during the first trimester of pregnancy. Multiple congenital anomalies (including bradyphrenia, auricular dysplasia, excessive anterior fontanelle enlargement, hip dysplasia, and brachio-ulnar synostosis) have been reported in infants born to mothers who received high doses of fluconazole (400-800 mg/day) for at least three months or more for the treatment of coccidioidomycosis. The relationship between fluconazole use and these cases has not been established.
Animal studies have shown reproductive toxicity.
Normal doses of fluconazole and short-term courses of fluconazole should not be used during pregnancy unless absolutely necessary.
High doses of fluconazole and/or long courses of fluconazole treatment should not be used during pregnancy, except for the treatment of life-threatening infections.
Children
The medicine can be used in children from birth.
Drivers
No studies have been conducted on the effect of the drug on the ability to drive or operate other mechanisms.
Patients should be informed about the possibility of dizziness or convulsions when using the drug. If such symptoms develop, it is not recommended to drive a car or operate other mechanisms.
Overdose
There have been reports of overdose with fluconazole; 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 reported adverse reactions (> 1/10) were: headache, abdominal pain, diarrhea, nausea, vomiting, rash, increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase in the blood.
Astemizole. Concomitant use of fluconazole may reduce the clearance of astemizole. The resulting increase in plasma astemizole concentrations may lead to QT prolongation and, in rare cases, torsades de pointes. Concomitant use of fluconazole is contraindicated.
Pimozide and quinidine. Concomitant use of fluconazole and pimozide or quinidine may result in inhibition of the metabolism of pimozide or quinidine, although in vitro and in vivo studies have not been conducted. Increased plasma concentrations of pimozide or quinidine may cause prolongation of the QT interval and, in rare cases, may lead to paroxysmal torsades de pointes. Concomitant use of fluconazole and pimozide or quinidine is contraindicated.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 5 years.
