Fluconazole Darnytsia capsules of 150 mg blister 1 pc

Fluconazole Darnytsia capsules are prescribed for the following indications:

adults:

• Treatment: cryptococcal meningitis; coccidioidosis; invasive candidiasis; candidiasis of the mucous membranes, including candidiasis of the oropharynx, esophagus, candiduria, chronic candidiasis of the skin and mucous membranes; chronic atrophic candidiasis (candidiasis caused by the use of dental prostheses) 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, smooth skin, inguinal dermatomycosis, lichen planus, candidal infections of the skin, when systemic therapy is not appropriate; Dermatophyte onychomycosis, when the use of other drugs is not appropriate.
• Prevention: relapse of cryptococcal meningitis in patients with a high risk of its development; recurrence of candidiasis of the oropharynx or esophagus in patients with HIV with a high risk of its development; decrease in the frequency of recurrences 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).

children:

• Treatment: cryptococcal meningitis; candidiasis of mucous membranes; invasive candidiasis.
• Prevention of candidal infections in patients with reduced immunity.
• The drug can be used as a supportive therapy to prevent relapse of cryptococcal meningitis in children with a high risk of developing it.
• Drug therapy can be started before receiving the results of cultural and other laboratory studies; after receiving the results, the antibacterial treatment should be adjusted accordingly.

Composition

Active substance: flusonazole;

1 capsule contains fluconazole 50 mg, 100 mg or 150 mg;

Excipients: potato starch, lactose monohydrate, colloidal anhydrous silicon dioxide, sodium lauryl sulfate, magnesium stearate, gelatin, titanium dioxide (E 171).

Contraindication

• Hypersensitivity to fluconazole, other azole compounds or other components of the medicinal product;
• Simultaneous use of fluconazole and terfenadine in patients who use fluconazole repeatedly in doses of 400 mg/day and above (according to the results of the study of the interaction of multiple use);
• Concomitant use of fluconazole and other drugs that prolong the QT interval and are metabolized by the CYP3A4 enzyme (eg, cisapride, astemizole, pimozide, quinidine, and erythromycin).

Method of application

Take the medicine orally. Swallow the capsules whole regardless of the meal.

The dose of the drug depends on the type and severity of the fungal infection. For most cases of vaginal candidiasis, a single use of the drug is enough. If multiple use of the medicinal product is necessary, the treatment of infections should be continued until the disappearance of clinical and laboratory manifestations of the activity of a fungal infection. Insufficient duration of treatment can lead to the resumption of an active infectious process.

Features of application

pregnant

Data obtained with single or repeated use of fluconazole in usual doses (<200 mg/day) to several hundred pregnant women during the first trimester of pregnancy did not demonstrate adverse effects on the fetus. Numerous congenital pathologies in newborns (including brachycephaly, dysplasia of the auricle, excessive enlargement of the anterior fontanelle, curvature of the hip, humeral synostosis) have been reported when pregnant women have received high doses of fluconazole (400-800 mg/day) for at least 3 months to treat coccidiosis. The relationship between the use of fluconazole and these cases has not been determined.

Animal studies have shown reproductive toxicity.

Usual doses of fluconazole and short-term courses of fluconazole should not be used during pregnancy unless absolutely necessary.

High doses of fluconazole and/or prolonged courses of fluconazole should not be used during pregnancy, except for the treatment of life-threatening infections.

Children

The drug in the form of capsules can be used in this category of patients when children are able to safely swallow a capsule, which is usually possible at the age of 5 years and older.

Drivers

Studies on the effect of fluconazole on the ability to drive vehicles or work with other mechanisms have not been conducted. Patients should be informed about the possibility of dizziness or convulsions when using the drug. When developing such symptoms, it is not recommended to drive vehicles or other mechanisms.

Overdose

Fluconazole overdose and the development of hallucinations and paranoid behavior have been reported.

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 blood plasma by approximately 50%.

Side effects

The following adverse reactions were reported most often (> 1/10): 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 Simultaneous use of the above drugs and fluconazole can lead to prolongation of the QT interval, paroxysmal ventricular tachycardia of the “pirouette” type and, as a result, to sudden death. The use of a combination of these drugs is contraindicated.

Storage conditions

Store in the original packaging at a temperature not higher than 25 °C.

Keep out of the reach of children.

Shelf life – 3 years.