Fluconazole-Teva capsules are indicated for the treatment of diseases in adults such as:
Prevention of such diseases in adults as:
Children.
It is possible to use the preparation in the form of capsules for this category of patients when children are able to safely swallow the capsule, which is usually possible from the age of 5.
Fluconazole-Teva is used in children for the treatment of mucosal candidiasis (oropharyngeal candidiasis, esophageal candidiasis), invasive candidiasis, cryptococcal meningitis, and for the prevention of candidiasis infections in immunocompromised patients. The preparation can be used as maintenance therapy to prevent recurrence of cryptococcal meningitis in children at high risk of developing it.
Fluconazole-Teva therapy can be started before the results of culture and other laboratory tests are obtained; after receiving the results of antibiotic therapy, it should be adjusted accordingly.
Active substance: fluconazole;
1 hard capsule contains 50 mg or 100 mg or 200 mg of fluconazole;
Excipients:
Capsule contents: lactose, corn starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate;
Capsule shell: titanium dioxide (E 171), brilliant blue FCF (E 133), gelatin, azorubin (E 122) (only for 200 mg capsules).
Hypersensitivity to fluconazole, to other azole substances or to any of the excipients of the preparation.
Concomitant use of fluconazole with terfenadine is contraindicated in patients taking fluconazole multiple times in doses of 400 mg per day or higher (based on the results of interaction studies with repeated use).
Concomitant use of fluconazole with other preparations that cause prolongation of the QT interval and are metabolized by the CYP3A4 enzyme (for example, cisapride, astemizole, pimozide, quinidine, amiodarone and erythromycin), see also sections.
Fluconazole can be administered orally or as an intravenous infusion, the route of administration depends on the clinical condition of the patient. When switching from intravenous to oral or vice versa, there is no need to change the daily dose.
Pregnant
You should not use the usual doses of fluconazole and short-term courses of treatment with fluconazole during pregnancy, unless absolutely necessary.
Do not use high doses of fluconazole and / or long courses of treatment with fluconazole during pregnancy, except for the treatment of infections that can be life-threatening.
Children
It is possible to use the preparation in the form of capsules for this category of patients when children are able to safely swallow the capsule, which is usually possible from the age of 5.
Drivers
Studies of the effect of the preparation on the ability to drive vehicles or work with other mechanisms have not been carried out.
Patients should be informed about the possible development of dizziness or seizures while using the preparation. With the development of such symptoms, it is not recommended to drive vehicles or work with other mechanisms.
Fluconazole overdose has been reported; hallucinations and paranoid behavior were simultaneously reported.
In case of overdose, it is necessary to carry out symptomatic supportive therapy and, if necessary, to flush the stomach.
Fluconazole is largely excreted in the urine; forced diuresis can accelerate the elimination of the preparation. A hemodialysis session lasting 3 hours reduces plasma levels of fluconazole by approximately 50%.
The most common (> 1/10) adverse reactions were reported: headache, abdominal pain, diarrhea, nausea, vomiting, rash, increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and blood alkaline phosphatase (Lf).
Astemizole. The combined use of fluconazole and astemizole may decrease the clearance of astemizole. The resulting increase in the concentration of astemizole in the blood plasma can lead to a prolongation of the QT interval and, in rare cases, to paroxysmal ventricular tachycardia of the "feasting" type. Concomitant use of fluconazole and astemizole is contraindicated.
Pimozide and quinidine. The combined use of fluconazole and pimozide or quinidine can lead to inhibition of the metabolism of pimozide or quinidine, although no relevant in vitro and in vivo studies have been performed. An increase in the concentration of pimozide or quinidine in blood plasma can cause prolongation of the QT interval and, in rare cases, lead to the development of paroxysmal ventricular tachycardia of the "feasting" type. Concomitant use of fluconazole and pimozide or quinidine is contraindicated.
Store in its original packaging at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life is 3 years.
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