The drug "Flunol ®" is used for the following indications:
Acute vaginal candidiasis when topical therapy is not appropriate; Candidal balanitis when topical therapy is not appropriate.
Composition
The active substance is fluconazole (one capsule contains 150 mg of fluconazole).
Excipients: lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; hard gelatin capsule: gelatin, titanium dioxide (E 171), azorubine (E 122).
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
Capsules should be swallowed whole. The drug is taken regardless of food intake. Adults: the drug is administered orally in a dose of 150 mg once.
Application features
Pregnant women
Data obtained from single or repeated administration of fluconazole at usual doses (<200 mg/day) to several hundred pregnant women during the first trimester of pregnancy have not shown any adverse effects on the fetus. Numerous congenital anomalies (including bradyphrenia, auricular dysplasia, excessive enlargement of the anterior fontanelle, hip curvature, brachio-ulnar synostosis) have been reported in newborns whose mothers received high doses of fluconazole (400-800 mg/day) for at least three or more months for the treatment of coccidioidomycosis. The relationship between the use of fluconazole and these cases has not been established. Fluconazole at usual doses and short courses of fluconazole should not be used during pregnancy unless clearly necessary. Fluconazole at high doses 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 multiple doses of fluconazole or with high doses of fluconazole.
Children
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 "Flunol ®" in children. If there is an urgent need to use the drug in children (aged 12 to 17 years), the usual adult doses should be used.
Drivers
Studies on the effect of this drug on the ability to drive or use machines have not been conducted. Patients should be informed about the possibility of dizziness or convulsions when using this drug. If such symptoms develop, it is not recommended to drive or operate complex machinery.
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 the elimination of the drug. A 3-hour hemodialysis session reduces the plasma level of fluconazole by 50%.
Side effects
The most common adverse reactions (> 1/10) are headache, abdominal pain, diarrhea, nausea, vomiting, rash, increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase in the blood.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 4 years.
