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: & nbspfilm coated tablets
    Composition:
    Active substance: fluconazole 50 mg, 100 mg or 150 mg.
    Excipients: lactose, potato starch, povidone 25 (kollidon 25), silicon dioxide colloid (aerosil), magnesium stearate. Sheath composition: hypromellose (hydroxypropylmethylcellulose), titanium dioxide, talc, polyethylene glycol 6000 (macrogol 6000), polysorbate (Tween 80).

    Description:
    Round tablets of biconvex form, covered with a film membrane, white or white with a cream shade of color.

    Pharmacotherapeutic group:Antifungal agent.
    ATX: & nbsp

    J.02.A.C   Triazole derivatives

    J.02.A.C.01   Fluconazole

    Pharmacodynamics:
    Fluconazole, a representative of the class of triazole antifungal agents, 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 in endemic mycosis models, including infections caused by Blastomyces dermatitidis, Coccidiodes immitis and Histoplasma capsulatum.

    Pharmacokinetics:
    After oral administration fluconazole it is well absorbed, its bioavailability is 90%. The maximum concentration after ingestion, fasting 150 mg is 90% of the plasma content when administered intravenously at a dose of 2.5 - 3.5 mg / l. Simultaneous food intake does not affect the absorption of the drug taken internally. The concentration in the plasma reaches a peak after 0.5-1.5 hours after administration, the half-life of fluconazole is about 30 hours. The plasma concentrations are in direct proportion to the dose.90% level of equilibrium concentration is reached by 4-5 days of treatment with the drug (with the administration of 1 time / day).
    The introduction of a shock dose (on the first day), which is 2 times greater than the usual daily dose, makes it possible to achieve 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 is 11-12%.
    Fluconazole well penetrates into all body fluids. Concentrations of 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.
    Fluconazole is excreted mainly by the kidneys; approximately 80% of the administered dose is excreted in the urine unchanged. The clearance of fluconazole is proportional to the creatinine clearance. Metabolites of fluconazole in peripheral blood were not detected.

    Indications:
    -cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with normal immune response, and in patients with various forms of immunosuppression (incl.in patients with AIDS, with organ transplantation); the drug can be used to prevent cryptococcal infection in AIDS patients;
    -generative candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infections (infections of the abdominal cavity, endocardium, eyes, respiratory and urinary tracts). Treatment can be performed in patients with malignant neoplasms, in intensive care units, in patients undergoing cytostatic or immunosupressive therapy, and in the presence of other factors predisposing to the development of candidiasis;
    -candidosis of mucous membranes, incl. oral cavity and pharynx (including atrophic candidiasis of the oral cavity, associated with the wearing of dentures), esophagus, non-invasive bronchopulmonary candidiasis, kandvduria, 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 per year); kavdidozny balanitis;
    -prophylaxis of fungal infections in patients with malignant neoplasms that are predisposed to such infections as a result of chemotherapy with cytostatics or radiation therapy;
    - mikozy skin, including mycosis of the feet, body, inguinal area; pityriasis lichen, onychomycosis; candidiasis of the skin;
    - Deep endemic mycoses, including coccidiomycosis, paracoccidiomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.

    Contraindications:
    - simultaneous reception of terfenadine or astemizole and other drugs that extend the QT interval.
    -increased sensitivity to the drug or similar in structure to azole compounds.
    -baby age (up to 3 years).



    Carefully:
    Hepatic and / or renal failure, simultaneous reception of potentially hepatotoxic drugs, alcoholism, potentially-
    proaritmogenic states in patients with multiple risk factors (organic heart diseases, electrolyte balance disorders, simultaneous intake of drugs that cause arrhythmias).
    Pregnancy and lactation:
    The use of the drug in pregnant women is not advisable, except for severe or life-threatening forms of fungal infections, if the expected effect exceeds the possible risk to the fetus.
    Fluconazole is found in breast milk in the same concentration as in plasma, so its use during lactation is not recommended.
    Dosing and Administration:
    Inside.
    Adults with cryptococcal meningitis and cryptococcal infections of other sites on the first day are usually prescribed 409 mg (8
    tablets of 50 mg), and then continue treatment at a dose of 200 mg - 400 mg 1 time / day. The duration of treatment for cryptococcal infections depends on the clinical efficacy, confirmed by mycological examination; in cryptococcal meningitis, it usually lasts at least 6-8 weeks.
    To prevent the recurrence of cryptococcal meningitis in AIDS patients, after completing the full course of primary treatment, fluconazole prescribe a dose of 200 mg per day for a long period of time.
    With candidemia, disseminated candidiasis and other invasive candidiasis infections, the dose usually amounts to 400 mg of Bi for the first day, and then for 200 mg. With insufficient clinical effectiveness, the dose of the drug can be increased to 400 mg per day. The duration of therapy depends on clinical efficacy.
    With oropharyngeal candidiasis, the drug is usually prescribed 50-100 mg 1 time / day; duration of treatment - 7 - 14 days.If necessary, patients with a marked decrease in immunity treatment may be longer.
    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.
    . For other candidiasis localizations (with the exception of genital candidiasis), for example, with esophagitis, noninvasive bronchopulmonary disease, candiduria, candidiasis of the skin and mucous membranes, etc., the effective dose is usually 50-100 mg / day with a treatment duration of 14 to 30 days. 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 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. Some patients may need more frequent use.
    With balanitis caused by Candida, fluconazole appoint a single dose of 150 mg orally.
    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 severe 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 another 7 days.
    With mycosis of the skin, including mycosis of the feet, skin of the inguinal area, and skin candidiasis, the recommended dose is 150 mg once a week or 50 mg 1 time / day. Duration of therapy in usual cases is 2-4 weeks, however, with foot mycoses, longer therapy (up to 6 weeks) may be required. .
    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 it is sufficient to receive 300-400 mg once; an alternative treatment regimen is to apply 50 mg once a day for 2 to 4 weeks.
    In case of onychosis, the recommended dose is 150 mg once a week.Treatment should continue until the replacement of the infected nail (growth of uninfected nail). For the repeated growth of the nails on the fingers and toes normally takes 3-6 months. and 6 - 12 months. respectively.
    With deep endemic mycoses, it may be necessary to use the drug at a dose of 200 mg to 400 mg per day for up to 2 years. The duration of therapy is determined individually; she can make up. 11 - 24 months with coccidiomycosis; 2-17 months. with paracoccidiomycosis;
    1 - 1b 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 that would exceed that in adults, i.e. not more than 400 mg per day. The drug is used daily 1 time / day.
    When candidiasis of mucous membranes is recommended, the dose of fluconazole. is 3 mg / kg / day. On the first day, a shock dose of 6 mg / kg may be prescribed in order to more quickly achieve permanent. equilibrium concentrations. -
    For treatment of generalized candidiasis or cryptococcal infection, the recommended dose is 6-12 mg / kg / day, depending on the severity of the disease.
    For the prevention of fungal infections in children with reduced immunity, where the risk of infection is associated with neutropenia, resulting from cytotoxic chemotherapy or radiotherapy, the drug is prescribed at 3-12 mg / kg / day, depending on the severity and duration of preservation of induced neutropenia.
    In children with impaired renal function, the daily dose of the drug should be reduced (in the same proportional relationship as in adults), according to the degree of renal insufficiency.

    Application of Fluconazole 50 mg tablets v children from 4 to 15 years

    Diseases

    Weight and weight of the child


    4-6 years the average weight of the child is 15-20 kg

    7-9 years old child's average weight 21-29 kg

    10-12 years the average weight of the child is 30-40 kg

    12-15 years old the average child weight is 40-50 kg

    'Candidiasis of the esophagus (Zmg / kg / day)

    1 tablet 50 mg per day

    1-2 tablets 50 mg per day

    2 tablets of 50 mg

    once

    2-3 tablets 50 mg each

    once

    Treatment period

    For at least 3 weeks and within 2 weeks after regression of symptoms

    Candidiasis

    mucous

    shells

    (Zmg / kg / day)

    In the 1st day: 2-3 tablets Further: 1 tablet per day

    In the 1st day: 2-4 tablets Next: 1-2 tablets per day

    In the 1st laziness: 4- 5 tablets Next: 2 tablets per day

    once

    In the first laziness: 5- 6 tablets Next: 2-3 tablets per day

    once

    Treatment period

    On the first day, a shock dose is given to achieve a more rapid steady-state equilibrium concentration, then treatment is continued for at least 3 weeks

    Generalized candidiasis and cryptococcal infection (incl.

    meningitis)

    (6-12 mg / kg / day)

    2-5 tablets per day-

    2-6 tablets per day

    4-7 tablets per day

    5-8 tablets per day

    Treatment period

    Within 10-12 of absence;

    weeks (before laboratory confirmation of the sturgeon in the cerebrospinal fluid)

    Prevention of fungal infections in children with reduced immunity, whose risk of infection is associated with neutropenia, resulting from cytotoxic chemotherapy or radiation therapy (3-12 mg / kg / day)

    1-5 tablets per day

    1-6 tablets in. day

    2-7 tablets per day

    2-8 tablets per day

    Treatment period

    The drug is given in doses, depending on the severity and duration of preservation of induced neutropenia.


    In elderly patients, in the absence of impaired renal function, the usual dosage regimen should be followed.
    Patients with renal insufficiency (creatinine clearance less than 50 ml / min) dosage regimen should be adjusted as indicated 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. When re-administering the drug, patients with impaired renal function should first introduce a shock dose of 50 mg to 400 mg. If creatinine clearance (CC) is greater than 50 ml / myn applied normal dose (100% of the recommended dose). 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 hemodialysis session ..

    Side effects:
    From the digestive system: loss of appetite, changes in taste, abdominal pain, vomiting, nausea, diarrhea, flatulence, abdominal pain, rarely - liver dysfunction (jaundice, hepatitis, gepatonekroz, hyperbilirubinemia, increased alanine aminotransferase activity, aspartate aminotransferase, increased alkaline phosphatase , hepatocellular necrosis), incl. heavy.
    From the nervous system: headache, dizziness, excessive fatigue, rarely - convulsions.
    From the hematopoiesis: rarely - leukopenia,
    Thrombocytopenia (bleeding, petechiae), neutropenia, agranulocytosis.
    Allergic reactions: skin rash, rarely - erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactoid reactions (including angioneurotic edema, swelling of the face, hives, itchy skin) .
    From the cardiovascular system: enlargement
    duration of the Q-T interval, fibrillation / flutter of the ventricles.
    Other: rarely - a violation of kidney function, 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 to carefully monitor the prothrombin time in patients receiving the drug in combination with coumarin anticoagulants.
    Fluconazole increases plasma half-life
    oral hypoglycemic agents
    derivatives
    sulfonylureas (chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy people. Joint use of fluconazole and oral hypoglycemic agents in diabetics is allowed, but the doctor must have in mind the possibility of developing hypoglycemia.
    The simultaneous use of fluconazole and phenytoin may lead to an increase in the concentration of phenytoin in plasma to a clinically significant degree. 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, it is advisable to increase the dose of Fluconazole.
    It is recommended to monitor the concentration of cyclosporine in the blood in patients receiving Fluconazole, since the use of fluconazole and cyclosporine in patients with kidney transplantation taking Fluconazole at a dose of 200 mg / day leads to a slow increase in the concentration of cyclosporine in the plasma.
    Patients who receive high doses of theophylline or who are likely to develop theophylline intoxication should be monitored for the early detection of symptoms of a theophylline overdose *, as taking fluconazole leads to a decrease in the average clearance rate of theophylline from the plasma.
    With simultaneous application Fluconazole and terfenadine, cisapride, cases of unwanted reactions from the heart, including paroxysms of ventricular tachycardia (torsades de points), have been described.
    Simultaneous application of fluconazole and hydrochlorothiazide may lead to an increase in the concentration of fluconazole in plasma at
    40%.
    There have been reports of an interaction between 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, so an increase in the side effects of zidovudine should be expected.
    Increases the concentration of midazolam, which increases the risk of developing psychomotor effects (most pronounced when fluconazole is administered orally than intravenously).
    Increases the concentration of tacrolimus, in connection with which, the risk of nephrotoxic action increases.

    Special instructions:
    Treatment should be continued until the appearance of clinical and hematologic remission. Premature termination of treatment leads to relapse.
    In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, incl. with a fatal outcome, mainly in patients with serious concomitant diseases. In the case of hepatotoxic effects associated with fluconazole, there was no apparent dependence on total daily dose, duration
    therapy, sex, and age of the patient. Hepatotoxic effect
    fluconazole was usually reversible; signs of 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 those cases when the rash develops in patients with superficial fungal infection and it is regarded as definitely associated with fluconazole, the drug should be discontinued. When rashes appear in patients with invasive / systemic fungal infections, they should be carefully monitored and canceled fluconazole when there are bullous changes or erythema multiforme. ,
    Care should be taken when taking fluconazole simultaneously with cisapride, rifabutin, or other drugs metabolized by the cytochrome P450 system.

    Form release / dosage:
    Tablets, film-coated 50 mg.
    Tablets coated with a film coat of 100 mg.
    Tablets, film-coated with 150 mg.

    Packaging:
    For dosages of 50 mg and 100 mg - 10 tablets per contour cell pack of PVC and aluminum foil.
    1 circuit cell pack together with the instruction for use is put in a pack of cardboard.
    For a dosage of 150 mg - 2 tablets in a contour mesh package made of PVC and aluminum foil.
    1 circuit cell pack together with the instruction for use is put in a pack of cardboard.

    Storage conditions:
    In a dry, the dark place at a temperature of no higher than 30 ° 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:LSR-007321/08
    Date of registration:12.09.2008
    The owner of the registration certificate:TECHNOLOG, JSC TECHNOLOG, JSC Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp16.10.2015
    Illustrated instructions
      Instructions
      Up