Flucoric capsules 150 mg No. 1




Flucoric capsules are prescribed for:
Acute vaginal candidiasis when local therapy is not appropriate. Candidal balanitis when local therapy is not appropriate.Composition
Active ingredient: fluconazole;
1 capsule contains 150 mg of fluconazole;
Excipients: lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate.
Contraindication
Hypersensitivity to fluconazole, other azole compounds or to other components 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 medicine is to be taken orally. Swallow the capsules whole, regardless of the meal.
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 have been reported in newborns (including brachycephaly, auricular dysplasia, excessive enlargement of the anterior fontanelle, hip dysplasia, brachio-ulnar synostosis) when pregnant women received high doses of fluconazole (400-800 mg/day) for at least 3 months for the treatment of coccidioidomycosis. The relationship between the use of fluconazole and these cases has not been determined.
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 drug in capsule form can be used in this category of patients when children are able to safely swallow the capsule, which is usually possible from the age of 5.
Drivers
Studies on the effect of fluconazole on the ability to drive or use machines have not been conducted. Patients should be informed of the possibility of dizziness or convulsions when using the drug. If such symptoms develop, it is not recommended to drive or use machines.
Overdose
There have been reports of fluconazole overdose and the development of hallucinations and paranoid behavior.
Treatment: symptomatic supportive therapy and, if necessary, gastric lavage. Fluconazole is largely excreted in the urine, so forced diuresis can accelerate the elimination of the drug. A 3-hour hemodialysis session reduces the level of fluconazole in the blood plasma by approximately 50%.
Side effects
The most frequently 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.
Interaction
Cisapride, astemizole, pimozide, quinidine, erythromycin Concomitant use of the above drugs and fluconazole may lead to QT prolongation, torsades de pointes, and, as a result, sudden death. The combination of these drugs is contraindicated.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 3 years.
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