KRKA #Urogenital_tract #Vaginal_infections_and_irritations #HEALTH_CARE
Product description
Diflazon capsules are used to treat diseases in adults such as:
- cryptococcal meningitis;
- coccidioidosis;
- invasive candidiasis;
- candidiasis of the mucous membranes, including candidiasis of the oropharynx and candidiasis of the esophagus, candiduria, chronic candidiasis of the skin and mucous membranes;
- chronic atrophic candidiasis (candidiasis caused by the use of dentures) with the ineffectiveness of local dental hygiene products;
- vaginal candidiasis, acute or recurrent when local therapy is not appropriate;
- candidal balanitis when local therapy is not appropriate;
- dermatomycosis, including mycosis of the feet, mycosis of smooth skin, inguinal ringworm, tinea versicolor and candidal skin infections, when systemic therapy is not appropriate;
- dermatophytic onychomycosis, when the use of other preparations is not appropriate;
Prevention of such diseases in adults as:
- relapse of cryptococcal meningitis in patients at high risk of its development;
- recurrence of oropharyngeal or esophageal candidiasis in patients with HIV at high risk of developing it;
- a decrease in the frequency of relapses of vaginal candidiasis (4 or more cases per year);
- prevention of candidal infections in patients with long-term neutropenia (for example, patients with malignant blood diseases receiving chemotherapy or patients with hematopoietic stem cell transplantation);
Treatment of children: candidiasis of the mucous membranes (oropharyngeal candidiasis, esophageal candidiasis), invasive candidiasis, cryptococcal meningitis and for the prevention of candidiasis infections in patients with reduced immunity (the preparation can be used as supportive therapy to prevent recurrence of cryptococcal meningitis in children at high risk of its development).
Compound
Active substance: fluconazole;
1 capsule contains fluconazole 50 mg or 100 mg or 150 mg;
Excipients: lactose, corn starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate;
Capsule: titanium dioxide (E 171), patented blue V dye (E 131), gelatin.
Contraindications
hypersensitivity to fluconazole, other azole compounds or to any of the excipients of the preparation;
the simultaneous use of fluconazole and terfenadine in patients who use fluconazole multiple times at doses of 400 mg / day and above (according to the results of a study of the interaction of repeated use);
concomitant use of fluconazole and other preparations that prolong the QT interval and are metabolized by the CYP3A4 enzyme (for example, cisapride, astemizole, pimozide, quinidine and erythromycin).
Mode of application
The daily dose of fluconazole depends on the type and severity of the fungal infection. For most cases of vaginal candidiasis, a single use of the preparation is sufficient. If necessary, repeated use of the preparation, the treatment of infections should be continued until the clinical and laboratory manifestations of the activity of the fungal infection disappear. Insufficient duration of treatment can lead to the resumption of an active infectious process.
The preparation is administered orally. The method of administration of the preparation depends on the clinical condition of the patient. The capsules should be swallowed whole. Taking the preparation does not depend on food intake.
Application features
Pregnant
Do not use the usual doses of fluconazole and short-term courses of treatment with fluconazole during pregnancy, unless absolutely necessary.
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, usually at the age of 5 years.
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 possibility of dizziness or seizures developing while using this preparation. With the development of such symptoms, it is not recommended to drive vehicles or work with other mechanisms.
Overdose
Fluconazole overdose has been reported; simultaneously reported hallucinations and paranoid behavior.
In case of an 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%.
Side effects
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.
Interaction
The simultaneous use of fluconazole and the following medicines is contraindicated:
Cisapride.
Terfenadine.
Astemizole.
Pimozide and quinidine.
Erythromycin.
Amiodarone.
Storage conditions
Store in its original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
The shelf life is 5 years.
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