Active substanceFluconazoleFluconazole
Similar drugsTo uncover
  • Vero-Fluconazole
    capsules inwards 
    VEROPHARM SA     Russia
  • Disorel-Sanovel
    capsules inwards 
  • Diflazon®
    solution d / infusion 
  • Diflucan®
    powder inwards 
    Pfizer Inc.     USA
  • Diflucan®
    capsules inwards 
    Pfizer Inc.     USA
  • Diflucan®
    solution in / in 
    Pfizer Inc.     USA
  • Micon
    solution d / infusion 
  • Medoflucon®
    capsules inwards 
    MEDSERV, LLC     Russia
  • Mycomomax®
    capsules inwards 
    Zentiva c.s.     Czech Republic
  • Mycosyst®
    capsules inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Mycosyst®
    solution d / infusion 
    GEDEON RICHTER, OJSC     Hungary
  • Mycoflucan®
    pills inwards 
  • Mycoflucan®
    solution d / infusion 
  • Nofung®
    capsules inwards 
  • Procanazole
    capsules inwards 
  • Fangifflu
    capsules inwards 
  • Flukozan
    solution d / infusion 
    LENS-PHARM, LLC     Russia
  • Flukoside
    capsules inwards 
  • Flukomabol®
    solution d / infusion 
    PREBAND PFC, LLC     Russia
  • Fluconazole
    capsules inwards 
  • Fluconazole
    capsules inwards 
    PHARMACY 36.6, CJSC     Russia
  • Fluconazole
    solution d / infusion 
  • Fluconazole
    capsules inwards 
  • Fluconazole
    solution d / infusion 
    RUSYUROFARM, LLC     Russia
  • Fluconazole
    capsules inwards 
    VALENTA PHARM, PAO     Russia
  • Fluconazole
    capsules inwards 
    REPLEK FARM Skopje, OOO     Macedonia
  • Fluconazole
    capsules inwards 
    FARMPROJECT, CJSC     Russia
  • Fluconazole
    solution d / infusion 
    EAST-FARM, CJSC     Russia
  • Fluconazole
    capsules inwards 
    OZONE, LLC     Russia
  • Fluconazole
    capsules inwards 
    BIOKOM, CJSC     Russia
  • Fluconazole
    capsules inwards 
    VERTEKS, AO     Russia
  • Fluconazole
    capsules inwards 
  • Fluconazole
    pills inwards 
    TECHNOLOG, JSC     Ukraine
  • Fluconazole
    capsules inwards 
    Hemofarm AD     Serbia
  • Fluconazole
    capsules inwards 
  • Fluconazole
    capsules inwards 
    Astrafarm, CJSC     Russia
  • Fluconazole
    capsules inwards 
    MEDISORB, CJSC     Russia
  • Fluconazole OBL
    capsules inwards 
  • Fluconazole Zentiva
    solution d / infusion 
    Zentiva c.s.     Czech Republic
  • Fluconazole Cabi
    solution d / infusion 
  • Fluconazole STADA
    capsules inwards 
  • Fluconazole-Acti
    solution d / infusion 
    Aktifarm, OOO     Russia
  • Fluconazole-Sandoz®
    capsules inwards 
    Sandoz d.     Slovenia
  • Fluconazole-Teva
    capsules inwards 
  • Flukonorm
    capsules inwards 
  • Flucorus®
    solution d / infusion 
    MS-VITA, LLC     Russia
  • Flukorem
    gel externally 
    REMEDIYA, LLC     Russia
  • Flucostat®
    solution d / infusion 
  • Flucostat®
    capsules inwards 
  • Forkan®
    solution d / infusion 
    Cipla Ltd.     India
  • Forkan®
    capsules inwards 
    Cipla Ltd.     India
  • Ciscan®
    capsules inwards 
  • Dosage form: & nbspcapsules
    Composition:
    active substance: fluconazole - 0.050 g or 0.150 g;
    auxiliary substances: lactose monohydrate (sugar milk) - 0.1804 g or - 0.19265 g, pregelatinized starch 0.0012 g or 0.00175 g, povidone (low molecular weight polyvinylpyrrolidone) 0.0012 g or 0.00175 g, silicon dioxide colloid (aerosil) 0.0048 g or 0.00035 g, magnesium stearate 0.0024 g or 0.0035 g; gelatin capsule composition: for dosage of 50 mg - body: gelatin - 0,038102 g, titanium dioxide E 171 - 0,000778 g, lid: gelatin - 0,022513 g,titanium dioxide E 171 - 0.000462 g, iron dye oxide yellow E 172 - 0.000145 g; for dosing 150 mg - body: gelatin - 0.045408 g, titanium dioxide E 171 - 0.000461 g, iron oxide dye
    yellow E 172 - 0.000231 g; lid: gelatin - 0.029648 g / titanium dioxide E17G - 0.000301 g, iron dye oxide yellow E 172 - 0.000151 g.

    Description:
    Hard gelatin capsules No. 2 are opaque white with a yellow lid (for a dosage of 50 mg) or hard gelatin capsules No. 1 opaque yellow with a yellow lid (for a dosage of 150 mg). The contents of capsules are white or white powder with a yellowish tinge.

    Pharmacotherapeutic group:Antifungal agent.
    ATX: & nbsp

    J.02.A.C   Triazole derivatives

    J.02.A.C.01   Fluconazole

    Pharmacodynamics:
    Fluconazole is a representative of the class of triazole antifungal agents, it is a potent selective inhibitor of the synthesis of sterols in the fungal cell:
    The drug is effective in opportunistic fungal infections, incl. caused by Candida spp., Cryptococcus neoformans, - Microsporum spp., Trichophyton spp. Also shown is the activity of fluconazole on models of endemic mycoses, including infections caused by Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum
    Pharmacokinetics:
    After oral administration fluconazole, is well absorbed, its bio availability is 90%.The maximum concentration, after oral administration of 150 mg, is 90% of the plasma content for intravenous administration at a dose of 2.5 to 3.5 mg / l. Simultaneous food intake does not affect the absorption of the drug taken internally. The maximum concentration is achieved after 0.5-1.5 hours after administration, the half-life period, fluconazole is about 30 hours. Concentrations in the plasma are in a direct proportion to the dose. 90% the level of equilibrium concentration reaches,
    to the 4th-5th day of treatment with the drug (when taken 1 time / day). , ,
    The introduction of the "shock" dose (on the first day), which is 2 times higher than the usual daily dose, allows reaching a level corresponding to 90% of the equilibrium concentration by the second day. The apparent volume of distribution approximates the total water content in the body. Binding to plasma proteins - 11-12%. -
    - Fluconazole well penetrates into all body fluids. Concentrations
    the drug in saliva and sputum are similar to those in plasma. In patients with fungal meningitis, the fluconazole content in the cerebrospinal fluid reaches 80% of its plasma level.
    In the stratum corneum, the epidermis, the dermis and the sweat fluid, high concentrations are reached that exceed the serum levels.
    It is an inhibitor of the isoenzyme CYP2C9 in the liver.
    The pharmacokinetics of fluconazole significantly depend on the functional state of the kidneys, and there is an inverse relationship between the half-life and the enema.
    flight of creatinine (CC): Fluconazole is excreted mainly by the kidneys; approximately 80% of the administered dose is excreted in the urine unchanged. Metabolites of fluconazole in peripheral blood were not detected.


    Indications:
    -cryptococcosis, including cryptococcal meningitis and other localizations1 of this infection (eg, lung, skin), both in patients with normal immune response and in patients with various forms of immunosuppression (in including in AIDS patients, with organ transplantation); the drug can be used to prevent cryptococcal infection in patients with AIDS;
    , -generative candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infections (peritoneal, endocardial, eye, respiratory and urinary tract infections). Treatment can be performed in patients with malignant neoplasms, in intensive care units, in patients undergoing cytostatic or immunosuppressive therapy, and in the presence of other factors predisposing to the development of candidiasis
    -candidosis of mucous membranes, incl. oral cavity and pharynx (incl.atrophic candidiasis of the oral cavity, associated with the wearing of dentures, 'oropharyngeal candidiasis), esophagus, non-invasive bronchopulmonary candidiasis, candiduria, candidiasis of the skin; prevention of recurrence of oropharyngeal candidiasis in AIDS patients;
    -genital candidiasis: vaginal candidiasis (acute and chronic recurrent), preventive use to reduce the frequency of recurrences of vaginal candidiasis (3 or more episodes a year); Candidiasis balanitis; ,
    , -prophylaxis of fungal infections in patients with malignant neoplasms,
    who are predisposed to such infections as a result of chemotherapy with cytostatics
    or radiotherapy;
    - mikozy skin, including mycosis of the feet, the body ', inguinal region; pityriasis lichen, they, hamycosis; candidiasis of the skin
    - Deep endemic mycoses, including coccidiomycosis, paracoccidiomycosis, sporotrichosis and histoplasmosis in patients with normal immunity

    Contraindications:
    - simultaneous administration of .terfenadine (against the background of a constant intake of fluconazole at a dose of 400 mg / day or more) or astemizole and other drugs that extend the Q-T interval; -increased sensitivity to the drug or a close structure of azoleconnections;
    - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption; .
    -Children's age (up to 3 years).

    Carefully:Hepatic and / or renal failure, simultaneous reception of potentially hepatotoxic drugs, alcoholism, the appearance of rash against the background of fluconazole in patients with superficial fungal infection and invasive / systemic fungal infections, concurrent administration of terfenadine and fluconazole at a dose of less than 400 mg / day, potentially pro-rhythmic . Conditions in patients with multiple factors, risk (organic heart disease, electrolyte balance disorders, concomitant use of medications that cause arrhythmias ).
    Pregnancy and lactation:
    The use of the drug in pregnant women is inappropriate, except for severe or life-threatening forms of fungal infections, if the intended benefit to the mother exceeds the possible risk to the fetus.
    Fluconazole is found in breast milk in the same concentration as in plasma, therefore its use during breast-feeding is not recommended.

    Dosing and Administration:
    Way of application inside; , . - '\-
    Adults with cryptococcal meningitis and kryptococcal infections of other locale-
    on the first day, usually prescribed 400 mg, and then continue treatment in a dose. 200-400 mg 1 time / day. The duration of treatment for cryptococcal infections depends on the clinical-effectiveness, confirmed by mycological examination; in cryptococcal meningitis, it is usually continued for at least 6-8 weeks.
    For. prevention of recurrence of cryptococcal meningitis in AIDS patients, after completion of a full course of primary treatment, -fluconazole is administered at a dose of 200 mg / day for a long period of time.
    With candidemia, disseminated candidiasis and other invasive candidiasis infections, the dose is usually 400 mg on the first day, and then on 200 mg. With insufficient clinical effectiveness, the dose of the drug can be increased to 400 mg / day.,: The duration of therapy depends on clinical effectiveness. -
    With oropharyngeal candidiasis, the drug is usually prescribed at 50-100 mg 1 time / day; the duration of treatment is 7:14 days. If necessary; in patients with a marked decrease in immunity, treatment may be longer. ,
    To prevent the recurrence of oropharyngeal candidiasis in AIDS patients after completing the full course of primary therapy, the drug can be prescribed 150 mg once a week.
    With atrophic candidiasis of the oral cavity, associated with the wearing of dentures, fluconazole usually prescribed 50 mg 1 time / day for 14 days in combination with local antiseptic agents for prosthesis treatment
    With other localizations of candidiasis (with the exception of genital candidiasis), for example, with esophagitis, a non-invasive bronchopulmonary lesion; Candidiasis, candidiasis of the skin and mucous membranes, etc., the effective dose is usually 50-100 mg / day for a long time.
    treatment for 14-30days.
    , With vaginal candidiasis fluconazole taken once inside the dose of 150 mg. To reduce the frequency of recurrences of vaginal candidiasis, the drug can be used at a dose of 150 mg once a month, the duration of therapy is determined individually, it varies from 4 to 12 months, and some patients may require more frequent use. ^
    With balanitis caused by Candida, fluconazole appoint a single dose of 150 mg
    inside.
    For the prevention of candidiasis. The recommended-dose of fluconazole is 50-400 mg
    1 time / day, depending on the degree of risk of fungal infection.If there is a high risk of generalized infection; for example, in patients with expected significant - or long-lasting. neutropenia ,. the recommended dose is 400 mg - 1 time / day. Fluconazole appoint a few days before the expected appearance of neutropenia; after increasing the number of neutrophils more than 1000 / mm3, treatment is continued for 7 days.
    With mycosis of the skin, including mycosis of the feet, skin of the inguinal region and skin candidiasis, the recommended dose is 150 mg once a week or 50 mg once a day. The duration of therapy in usual cases is 2-4 weeks, but with foot mycoses may require longer therapy (up to 6 weeks).
    With pityriasis, 300 mg once a week for 2 weeks, some patients require a third dose of 300 mg per week, while in some cases,
    accurate single dose of 300-400 mg; an alternative treatment regimen is to administer 50 mg once a day for 2-4 weeks.
    With onychomycosis, the recommended dose is 150 mg once a week. Treatment should continue until the replacement of the infected nail (growth of uninfected nails). For the repeated growth of nails on the fingers and toes, it normally takes 3-6 months and 6-12 months, respectively.
    .In severe deep endemic mycoses, a drug of 200-400 mg / day may be required for up to 2 years. The duration of therapy is determined individually; it can be 11-24 months with coccidiomycosis; 2-17 months with paracoccidiomycosis; 1-16 months with sporotrichosis and 3-17 months with histoplasmosis.
    In children; as with similar infections in adults, the duration of treatment depends on the clinical and mycological effect. In children, the drug should not be used in a daily dose, which would exceed that of adults. The drug is used daily 1 time / day. .
    When candidiasis of mucous membranes the recommended dose, fluconazole is 3 mg / kg / day. On the first day, a shock dose of 6 mg / kg may be prescribed in order to be more viable. strictly achieving constant equilibrium concentrations. , ,
    For the treatment of generalized candidiasis or cryptococcal infection (including meningitis), the recommended dose is 6-12 mg / kg / day for 10-12 weeks (before laboratory confirmation of the absence of pathogens in the CSF) . ’
    'For the prevention of fungal infections in children with reduced immunity, in which the risk of developing infection is associated with neutropenia developing as a result of cytotoxic-
    , chemotherapy, chemotherapy or radiotherapy, the drug is prescribed at 3-12 mg / kg / day in the
    . the severity and duration of preservation of induced neutropenia.
    In the case of children with impaired function of the kidneys, the daily dose of the drug should be reduced
    (in the same proportional relationship as in adults), according to the degree of renal insufficiency.
    In elderly patients, the usual dosing regimen should be followed in patients with no renal dysfunction Patients with renal insufficiency (creatinine clearance less than 50 mL / min) should be corrected as described below.
    Use of the drug in patients with impaired renal function.
    Fluconazole is excreted mainly with urine in unchanged form. With a single admission, a dose change is not required. With the repeated administration of the drug to patients with impaired renal function, a "shock" dose of 50 mg to 400 mg should be administered first.
    If the clearance of creatinine (CC) is more than 50 ml / min, the usual dose of the drug (100% of the recommended dose) is used. With SC from 11 to 50 ml / min, a dose equal to 50% of the recommended dose is applied.Patients regularly on dialysis, one dose of the drug is used after each session of hemodialysis.
    Side effects:
    On the part of the digestive system: nausea, vomiting, taste change, diarrhea, meteorism, abdominal pain, impaired liver function (jaundice, hyperbilirubinemia, increased activity, alanine aminotransferase, aspartate aminotransferase, increased alkaline phosphatase activity, hepatitis, hepatonecrosis) . with a lethal outcome.
    From the nervous system: headache, dizziness, convulsions.
    From the hematopoiesis: leukopenia, thrombocytopenia, neutropenia, agranulocytosis.
    From the cardiovascular system: an increase. duration of the Q-T interval, ventricular fibrillation / flutter. /
    Allergic reactions: skin rash, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactoid reactions (including angioedema, face swelling, hives, itching of the skin). Other: renal dysfunction, alopecia, hypercholesterolemia, hypertriglyceridemia, hypokalemia.

    Overdose:
    Symptoms: hallucinations, paranoid behavior.
    Treatment: symptomatic, gastric lavage, forced diuresis. Hemodialysis within 3 hours reduces the plasma concentration by approximately 50%.

    Interaction:
    When using fluconazole with warfarin, prothrombin time increases, (on average, by 12%). In this regard, it is recommended that the indicators
    prothrombin time in patients receiving the drug in combination with coumarin anticoagulants.
    Fluconazole increases the half-life of the plasma from the oral hypoglycemic agents of sulfonylureas (chlorpropamide, glibenclamide, glipizid, tolbutamide) in healthy people. Joint use of fluconazole and oral
    hypoglycemic agents in diabetic patients are allowed, however, the doctor should keep in mind the possibility of developing hypoglycemia.
    The simultaneous use of fluconazole and phenytoin can lead to an increase / concentration of phenytoin in the plasma to a clinically significant extent. Therefore, when it is necessary to jointly use these drugs, it is necessary to monitor the concentrations of phenytoin with correction of its dose in order to maintain the drug level within the therapeutic interval.
    The combination with rifampicin leads to a 25% reduction in AUC and a 20% decrease in the half-life of fluconazole from the plasma. Therefore, patients receiving concomitantly rifampicin, * the dose of fluconazole is advisable to increase.
    It is recommended to monitor the concentration of cyclosporine in the blood in patients receiving fluconazole, t. the use of fluconazole and cyclosporine in patients with kidney transplantation with fluconazole at a dose of 200 mg / day leads to a slow increase in the concentration of cyclosporin in plasma.
    Patients who receive high doses of theophylline or -which are likely to develop theophylline intoxication, should be monitored for the early detection of symptoms of theophylline overdose, tk. the administration of fluconazole 'leads to a decrease in the average clearance rate of theophylline from the plasma.
    With the simultaneous use of fluconazole and cisapride, cases of unwanted reactions from the heart, including paroxysms of ventricular tachycardia (torsades. Depoints), have been described.
    There are reports of the interaction of fluconazole and rifabutin, accompanied by an increase in serum levels of the latter.With the simultaneous use of fluconazole and rifabutin, cases of uveitis are described. It is necessary to carefully observe patients who simultaneously receive rifabutin and fluconazole.
    In patients receiving a combination of fluconazole and zidovudine,; an increase in the concentration of zidovudine is observed, which is caused by a decrease in the conversion of the latter into its main metabolite, therefore, one should expect an increase in the side effects of zidovudine.
    Fluconazole increases the concentration of midazolam increasing the risk of psychomotor 'effects (more pronounced when fluconazole is administered orally); tacrolimus - risk . - h
    nephrotoxicity.
    Hydrochlorothiazide increases the concentration of fluconazole in plasma by 40%.

    Special instructions:
    Treatment should continue until the appearance of clinical-hematologic remission. Premature termination of treatment leads to relapses
    Treatment can begin if there are no results, sowing results or other laboratory tests, but if they are (there is * recommended, appropriate correction of fungicidal therapy.
    In the course of treatment, it is necessary to monitor blood counts, kidney and liver function;
    If there are violations of kidney and liver function, stop taking the drug.
    In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, including. with a fatal outcome, mainly in patients with serious concomitant diseases. In the case of hepatotoxic effects; associated with fluconazo:
    . scrap, there was no apparent dependence on the total daily dose, duration of therapy, sex and age of the patient; The hepatotoxic effect of fluconazole was usually reversible; signs, it disappeared after discontinuation of therapy. If there are clinical signs of liver damage that may be associated with fluconazole, the drug should be discontinued. .
    Patients with AIDS are more likely to develop severe skin reactions with many drugs. In cases where a rash develops in patients with superficial fungal infection and it is regarded as definitely associated with fluconazole, the drug should be discontinued. When rashes occur, in patients with invasive / systemic fungal infections, they should be carefully monitored and canceled fluconazole when there are bullous changes or erythema multiforme.
    Caution should be exercised while taking fluconazole with cisapride, rifabutin or other drugs metabolized by the cytochrome P 450- '

    Effect on the ability to drive transp. cf. and fur:Impact on the ability to drive vehicles / machinery. Fluconazole does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Capsules 50 mg and 150 mg.

    Packaging:
    By 1,4,7 or 10 capsules in a contour cell package.
    For 1, 2 or 4 contour mesh packages together with instructions for use in a pack of cardboard.

    Storage conditions:
    In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:
    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000953
    Date of registration:03.10.2011
    The owner of the registration certificate:BIOKOM, CJSC BIOKOM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.09.2015
    Illustrated instructions
      Instructions
      Up