Fluzak is indicated for the treatment of the following diseases:
Prevention of such diseases in adults as:
active substance: fluconazole;
1 tablet contains fluconazole 50 mg, 150 mg or 200 mg
Excipients: calcium hydrogen phosphate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium starch (type A), sodium lauryl sulfate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), talc, E 124 Ponso 4R dye (E 124).
Fluconazole is an antifungal agent of the triazole class. The primary mechanism of its action is the suppression of fungal 14-alpha-lanosterol demethylation, mediated by cytochrome P450, which is an integral step in the biosynthesis of fungal ergosterol.
Hypersensitivity to fluconazole, other azole compounds or to any of the excipients of the preparation.
Concomitant use of fluconazole and terfenadine in patients who use fluconazole multiple times at doses of 400 mg / day or more (according to the results of a multiple-use interaction study).
Concomitant use of fluconazole and other preparations that prolong the QT interval and are metabolized by the CYPZA4 enzyme (for example, cisapride, astemizole, pimozide, quinidine, amiodarone and erythromycin).
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.
Fluconazole is used depending on the dosage form, orally or by infusion. The method of administration of the preparation depends on the clinical condition of the patient. There is no need to change the daily dose of the preparation when changing the route of its administration from administration to intravenous administration and vice versa.
The tablets should be swallowed whole. Taking the preparation does not depend on food intake.
Adults
Cryptococcosis.
Treatment of cryptococcal meningitis: The loading dose is 400 mg on the first day. The maintenance dose is 200-400 mg / day. The duration of treatment is usually at least 6-8 weeks. For life-threatening infections, the daily dose can be increased to 800 mg.
Supportive therapy to prevent recurrence of cryptococcal meningitis in patients at high risk of developing it: the recommended dose is 200 mg / day for an unlimited time.
Coccidioidosis.
The recommended dose is 200-400 mg / day. The duration of treatment is 11-24 months or longer, depending on the patient's condition. For some forms of infection, especially for meningitis, a dose of 800 mg / day may be appropriate.
Invasive candidiasis.
The loading dose is 800 mg on the first day. The maintenance dose is 400 mg / day. Usually, the recommended duration of treatment for candidemia is 2 weeks after the first negative blood culture results and the disappearance of the signs and symptoms of candidemia.
Candidiasis of the mucous membranes.
Oropharyngeal candidiasis: loading dose is 200-400 mg on the first day, maintenance dose is 100-200 mg / day. The duration of treatment is 7-21 days (until remission is achieved), but may be increased for patients with severe immunodeficiency.
Esophageal candidiasis, the loading dose is 200-400 mg on the first day, the maintenance dose is 100-200 mg / day. The duration of treatment is 14-30 days (until remission is achieved), but may be increased for patients with severe immunodeficiency.
Candiduria, the recommended dose is 200-400 mg / day for 7-21 days. For patients with severe immunodeficiency, the duration of treatment can be increased.
Chronic atrophic candidiasis, the recommended dose is 50 mg / day for 14 days.
Chronic candidiasis of the skin and mucous membranes, the recommended dose is 50-100 mg / day. The duration of treatment is up to 28 days, but may be increased depending on the severity and type of infection or decreased immunity.
Prevention of recurrence of mucosal candidiasis in patients with HIV who are at high risk of developing it.
Oropharyngeal candidiasis, esophageal candidiasis: the recommended dose is 100-200 mg / day or 200 mg 3 times a week. The duration of treatment is unlimited for immunosuppressed patients.
Prevention of candidal infections in patients with prolonged neutropenia.
The recommended dose is 200-400 mg. Treatment should begin several days before the expected development of neutropenia and continue for 7 days after the increase in the number of neutrophils more than 1000 / mm 3.
Genital candidiasis.
Acute vaginal candidiasis, candidal balanitis, the recommended dose is 150 mg once.
Treatment and prevention of recurrence of vaginal candidiasis (4 or more cases per year), the recommended dose is 150 mg 1 time in 3 days. A total of 3 doses should be applied (1st day, 4th day and 7th day). Thereafter, a maintenance dose of 150 mg should be used once a week for 6 months.
Dermatomycosis.
Mycosis of the feet, mycosis of smooth skin, inguinal ringworm, candidal infections of the skin, the recommended dose is 150 mg once a week or 50 mg once a day. The duration of treatment is 2-4 weeks. Treatment of mycosis of the feet can last up to 6 weeks.
Tinea versicolor, the recommended dose is 300-400 mg once a week for 1-3 weeks or 50 mg per day for 2-4 weeks.
Dermatophytic onychomycosis, the recommended dose is 150 mg once a week. Treatment should be continued until the infected nail is changed to a healthy one. It usually takes 3-6 months and 6-12 months for healthy fingernails and big toes to grow back, respectively. However, the rate of nail growth in patients may vary and depend on age. After successful treatment of long-term chronic infections, the shape of the nail sometimes remains altered.
Children
It is possible to use the preparation in the form of tablets for this category of patients when children are able to safely swallow the tablet, usually at the age of 5 years.
Application during pregnancy or lactation
Numerous congenital abnormalities have been reported in neonates (including brachycephaly, pinna dysplasia, excessive enlargement of the anterior fontanelle, curvature of the hip, brachiomenevic synostosis) whose mothers received high doses of fluconazole (400-800 mg / day) for at least three or more months for the treatment of coccidioidosis. The relationship between the use of fluconazole and these cases has not been determined.
Fluconazole passes into breast milk and reaches a lower concentration than in blood plasma. Breastfeeding can be continued after a single dose of fluconazole, which is 200 mg or less.
Breastfeeding is not recommended with repeated use of fluconazole or with high doses of fluconazole.
Fluconazole did not affect the fertility of males and females of the studied animals.
The ability to influence the reaction rate when driving or driving other mechanisms
Studies of the effect of the preparation Fluzac on the ability to drive vehicles or other mechanisms have not been carried out.
Patients should be informed about the possibility of developing dizziness or trial when using the preparation Fluzac. With the development of such symptoms, it is not recommended to drive vehicles or work with mechanisms.
Fluconazole overdose has been reported; hallucinations and paranoid behavior were simultaneously reported.
In case of an overdose, it is necessary to carry out symptomatic supportive therapy and, if necessary, flush the stomach.
Fluconazole is largely excreted in the urine; forced diuresis can accelerate the elimination of the preparation. A hemodialysis session lasting 3:00 reduces the plasma level of fluconazole by 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.
Interaction with other medicinal products and other types of interactions
The simultaneous use of fluconazole and the following preparations is contraindicated.
Cisapride. It was reported about the development of adverse reactions from the heart, including paroxysmal ventricular tachycardia of the "pirouette" type in patients who simultaneously used fluconazole and cisapride. A controlled study demonstrated that the simultaneous use of 200 mg of fluconazole once a day and 20 mg of cisapride 4 times a day led to a significant increase in the level of cisapride in blood plasma and prolongation of the QT interval. The simultaneous use of fluconazole and cisapride is contraindicated (see "Contraindications").
Terfenadine. Due to the development of severe cardiac arrhythmias caused by prolongation of the QTc interval in patients who use azole antifungal preparations simultaneously with terfenadine, interaction studies of these preparations have been conducted. In one study, when using fluconazole at a dose of 200 mg per day, no prolongation of the QTc interval was detected. Another study using fluconazole at doses of 400 mg and 800 mg per day demonstrated that the use of fluconazole at doses of 400 mg per day or higher significantly increased the level of terfenadine in blood plasma when these preparations were used simultaneously. Concomitant use of fluconazole 400 mg or higher with terfenadine is contraindicated (see "Contraindications"). When using fluconazole at doses below 400 mg per day concomitantly with terfenadine, the patient's condition should be carefully monitored.
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 "pirouette" 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 corresponding 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 "pirouette" type. Concomitant use of fluconazole and pimozide or quinidine is contraindicated.
Erythromycin. The simultaneous use of erythromycin and fluconazole can lead to an increased risk of cardiotoxicity (prolongation of the QT interval, paroxysmal ventricular tachycardia of the "pirouette" type) and, as a consequence, to sudden cardiac death. The use of a combination of these preparations is contraindicated.
Amiodarone. The simultaneous use of fluconazole with amiodarone can lead to inhibition of the metabolism of amiodarone. There was an association between the use of amiodarone and prolongation of the QT interval. Concomitant use of fluconazole and amiodarone is contraindicated.
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.
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