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:

    Each capsule contains :,

    Active substance: fluconazole - 150 mg. Excipients: lactose - 27.80

    mg, starch - 75.00 mg, silicon dioxide colloid - 0.25 mg, sodium lauryl sulfate - 0.25 mg, magnesium stearate - 1.70 mg.

    The composition of the capsule shell: dye Floxin B - 0.138 mg, dye sunset yellow - 0.021 mg, titanium dioxide - 2.16 mg, gelatin - 60.00 mg.

    Description:
    hard gelatin capsule No. 2, consisting of a white body and a pink lid.The contents of the capsule is a white or almost white powder.

    Pharmacotherapeutic group:Antifungal agent.
    ATX: & nbsp

    J.02.A.C   Triazole derivatives

    J.02.A.C.01   Fluconazole

    Pharmacodynamics:
    Antifungal agent, has a highly specific effect, inhibiting the activity of enzymes of fungi, dependent on cytochrome P450. Blocking the conversion of lanosterol of fungal cells to ergosterol; increases the permeability of the cell membrane, disrupts its growth and replication.
    Fluconazole, being highly selective for cytochrome P450 fungi, practically does not inhibit these enzymes in the human body (in comparison with itraconazole, clotrimazole, econazole and ketoconazole less inhibits oxidative processes dependent on cytochrome P450 in human liver microsomes). Does not have antiadrogenic activity.
    Active with opportunistic fungal infections, incl. caused by Candida spp. (including generalized forms of candidiasis on the background of immunodepression), Cryptococcus neoformans and Coccidioides immitis (including intracranial infections), Microsporum spp. and Trichophyton spp; with endemic mycoses caused by Blastomyces dermatidis, Histoplasma capsulatum (including with immunodepression).

    Pharmacokinetics:
    Absorption is high (food does not affect the rate of absorption), bioavailability is 90%.The time to reach the maximum concentration (TCmax) in plasma after oral administration of 150 mg - 0.5-1.5 h and maximum concentration (C max) in plasma with oral
    the introduction is 90% of the plasma concentration when administered intravenously (IV) at a dose of 2.5-3.5 mg / kg.
    The connection with plasma proteins is 11-12%. The concentration in the plasma is in direct proportion to the dose. The equilibrium concentration of the substance (Css) in the blood is reached by the 4-5 day of intake (when taken once a day). The introduction of a "shock" dose (on the first day), which is 2 times greater than the usual daily dose, allows one to achieve a concentration corresponding to 90% Css by day 2. Well penetrates into all body fluids. The concentration of the active substance in breast milk, articular fluid, saliva, sputum and peritoneal fluid is similar to that in plasma. Constant values ​​in the vaginal secretion are reached 8 hours after ingestion and are held at this level for at least 24 hours. It penetrates well into the cerebrospinal fluid (CSF); in fungal meningitis, the concentration in the CSF is about 85% of that in the plasma. In the fluid, epidermis and stratum corneum (selective accumulation), concentrations exceeding serum levels are achieved.After ingestion of 150 mg on day 7, the concentration in the stratum corneum is 23.4 μg / g, and 1 week after the second dose, 7.1 μg / g; concentration in the nails after 4 months of application at a dose of 150 mg once a week - 4.05 μg / g in healthy and 1.8 μg / g in the affected nails. The volume of distribution approximates the total water content in the body.
    The half-life (Tl / 2) is 30 hours. It is an inhibitor of the CYP2C9 isoenzyme in the liver. It is excreted mainly by the kidneys (80% - unchanged, 11% - in the form of metabolites). The clearance of fluconazole is proportional to the clearance of creatinine (CC). The pharmacokinetics of fluconazole significantly depends on the functional state of the kidneys, and there is an inverse relationship between Tl / 2 and KK. After hemodialysis in. for 3 hours the concentration of fluconazole in the plasma is reduced by 50%.

    Indications:
    Systemic lesions caused by fungi - Cryptococcus, including meningitis, sepsis, infections of the lungs and skin, both in patients with normal immune response, and in patients with various forms of immunodepression (including AIDS patients, organ transplantation); prevention of cryptococcal infection in AIDS patients.
    Generalized candidiasis: candidemia, disseminated candidiasis (with endocardial damage, abdominal organs, respiratory organs, eyes and urogenital organs), incl.in patients receiving a course of cytostatic or immunosuppressive therapy, as well as in the presence of other factors predisposing to their development - treatment and prevention. Candidiasis of mucous membranes: oral cavity, pharynx, esophagus, non-invasive bronchopulmonary candidiasis, candiduria, mucocutaneous and chronic oral atrophic candidiasis (associated with the wearing of dentures).
    Genital candidiasis: vaginal (acute and recurrent), balanitis.
    Prevention of fungal infections in patients with malignant tumors on the background of chemo- or radiation therapy; prevention of recurrence of oropharyngeal candidiasis in AIDS patients.
    Mycosis of the skin: stop, body, inguinal area, onychomycosis, pityriasis, skin candidiasis infections.
    Deep endemic mycoses (coccidioidosis, sporotrichosis and histoplasmosis) in patients with normal immunity.

    Contraindications:
    • hypersensitivity (including to the other azole antifungal drug (LS) in the anamnesis);
    • simultaneous reception of terfenadine (against the background of a constant intake of fluconazole at a dose of 400 mg per day or more) and astemizole;
    • lactation period.

    Carefully:
    • liver failure,
    • the appearance of a rash against the background of fluconazole in patients with superficial fungal infection and invasive / systemic fungal infections,
    • simultaneous reception of terfenadine and fluconazole in a dose of less than 400 mg per day,
    • potentially proaritmogenic states in patients with multiple risk factors (organic heart disease, electrolyte imbalance, concurrent use of drugs that cause arrhythmias),
    • pregnancy.

    Dosing and Administration:
    The drug Fangiflu should be taken internally. Adults, with cryptococcal infections, candidemia, disseminated candidiasis, other invasive candidiasis infections, 400 mg are prescribed on day 1, then 200-400 mg once a day. The duration of treatment depends on the clinical and mycological response (with cryptococcal meningitis is at least 6-8 weeks).
    For the prevention of cryptococcal meningitis in AIDS patients, therapy at a dose of 200 mg per day can be continued for a long time.
    With oropharyngeal candidiasis - 50-100 mg once a day for 7-10 days, in patients with immunosuppression -14 days or more.
    To prevent the recurrence of oropharyngeal candidiasis in AIDS patients after completing the full course of primary therapy - 150 mg once a week.
    At atrophic oral candidiasis, associated with the wearing of dentures; - 50 mg once a day for 14 days in combination with local antiseptic drugs for prosthesis treatment.
    With other candidiasis of the mucous membranes (with the exception of genital candidiasis) - 50-100 mg per day, the duration of treatment - 14-30 days.
    With vaginal candidiasis - 150 mg once. To reduce the frequency of relapses, once a month, 150 mg are used for 4-12 months, sometimes more frequent use may be required.
    With balanitis caused by Candida, 150 mg per day once.
    For the prevention of candidiasis, the recommended dose of the drug is 50-400 mg per 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 persistent neutropenia, the recommended dose is 400 mg per day. The drug Fangiflu is prescribed several days before the expected appearance of neutropenia; after an increase in the number of neutrophils more than 1 thousand / μl treatment is continued for another 7 days.
    For skin lesions, including foot mycoses, inguinal skin, and candidiasis - 150 mg once a week or 50 mg once a day, the duration of treatment is 2-4 weeks (up to 6 weeks with foot mycoses).
    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 take a single dose of 300-400 mg; an alternative treatment regimen is to administer 50 mg once a day for 2-4 weeks.
    With onychomycosis - 150 mg once a week; Treatment continues until the infected nail is replaced. For the repeated growth of nails on the fingers and toes, it normally takes 3-6 months and 6-12 months, respectively.
    At deep endemic mycoses - 200-400 mg per day for up to 2 years. The duration of therapy is determined individually; it can be 11-24 months with coccidioidomycosis, 2-17 months with paracoccidioidomycosis, 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 that would exceed that of adults. The drug is used daily 1 time per day (use special dosage forms for children).
    Children with esophageal candidiasis are prescribed 3 mg / kg per day once infor at least 3 weeks and within 2 weeks after the regression of the symptoms; at candidiasis of mucous membranes - 3 mg / kg per day once for at least 3 weeks; in the treatment of generalized candidiasis and cryptococcal infection (including meningitis) - 6-12 mg / kg per day for 10-12 weeks (before laboratory confirmation of the absence of pathogens in the cerebrospinal fluid).
    For the prevention of fungal infections in children with reduced immunity, the risk of infection is associated with neutropenia, resulting from cytotoxic chemotherapy or radiation therapy, 3-12 mg / kg per day, depending on the severity and duration of preservation of induced neutropenia.
    For newborn infants, the interval between injections is 72 hours, for children 2-4 weeks of age, the same dose is administered at intervals of 48 hours.
    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. In elderly patients in the absence of violations of kidney function should follow the usual dosage regimen.Patients with renal impairment (creatinine clearance less than 50 mL / min) dosing regimen should be adjusted as indicated below.
    In chronic renal failure initially introduced "shock" dose of 50-400 mg with CC 50 mL / min designate usual daily dose with CC 11-50 ml / min - 50% of the recommended dose or usual dose of 1 to 2 times of the day; patients undergoing hemodialysis, - 1 dose after each dialysis.

    Side effects:
    From the digestive system: nausea, diarrhea, flatulence, abdominal pain, change in taste, vomiting, rarely - liver dysfunction (jaundice, hyperbilirubinemia, elevated alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and alkaline phosphatase (ALP ), hepatitis, hepatocellular necrosis), incl. with a lethal outcome.
    From the nervous system: headache, dizziness, rarely - convulsions.
    From the side of hematopoiesis: rarely - leukopenia, thrombocytopenia, neytropenyya, agranulocytosis.
    Allergic YEAR: skin rash, rarely - erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome),
    anaphylactoid reactions (incl.angioedema, edema of the face, hives, itching of the skin).
    On the part of the cardiovascular system: an increase in the duration of the Q-T interval, fibrillation / flutter of the ventricles.
    Other: rarely - 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:
    Increases the effectiveness of coumarin anticoagulants (increased prothrombin time, warfarin - on average by 12%), zidovudine concentration (increase in side effects of zidovudine), cyclosporine (with fluconazole 200 mg / day), rifabutin (with simultaneous application of uveitis cases) and phenytoin in a clinically significant degree (with combined use, it is necessary to monitor the concentration of phenytoin in the plasma).
    Lengthens Tl / 2 theophylline and increases the risk of intoxication (it is necessary to correct its dose).
    Increases the concentration of midazolam - increased risk of psychomotor effects (more pronounced when fluconazole is administered orally,than in / in); tacrolimus - risk of nephrotoxicity.
    With the simultaneous administration of sulfonylurea derivatives (chlorpropamide, glibenclamide, glipizide and tolbutamide) should periodically monitor the concentration of A glucose, in the blood and, if necessary, to correct the dose of hypoglycemic medicines (t. fluconazole extends T1 / 2).
    Hydrochlorothiazide increases the concentration of fluconazole in plasma by 40%, rifampicin Reduces Tl / 2 by 20% and the area under the concentration-time curve (AUC) - by 25%. Terfenadine and cisapride increase the risk of arrhythmias, including paroxysms of ventricular tachycardia (torsades de pointes).

    Special instructions:
    Treatment should continue until the appearance of clinical-hematologic remission. Premature termination of treatment leads to relapse.
    Treatment can be started in the absence of seeding results or other laboratory tests, but if appropriate, a suitable correction of fungicidal therapy is recommended.
    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.The hepatotoxic effect of fluconazole is usually reversible, the symptoms disappear after discontinuation of therapy.
    Against the background of taking the drug in patients, there were rare cases of development of exfoliative skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients with AIDS and malignant neoplasms are more likely to develop severe skin reactions with many drugs. If the patient develops a superficial fungal infection of the rash during treatment, which can be associated with the use of fluconazole, the drug should be discontinued. When rashes appear in patients with invasive / systemic fungal infections, they should be carefully monitored and canceled fluconazole with the appearance of bullous lesions or erythema multiforme.
    It is necessary to control the prothrombin index while using the coumarinic anticoagulants simultaneously.
    It is recommended to monitor the concentration of cyclosporine in the blood in patients receiving fluconazole, t. In patients with kidney transplantation, fluconazole administration at a dose of 200 mg per day leads to a slow increase in the concentration of cyclosporine in the plasma.

    Form release / dosage:
    150 mg capsules
    Packaging:
    1 capsule in Al / PVC blisters.
    One blister along with the instructions for use are placed in a cardboard box.
    Storage conditions:
    In 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 printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-000223
    Date of registration:16.02.2011
    The owner of the registration certificate:Edge Pharma Private LimitedEdge Pharma Private Limited India
    Manufacturer: & nbsp
    Representation: & nbspEdge Pharma Private Limited Edge Pharma Private Limited India
    Information update date: & nbsp29.09.2015
    Illustrated instructions
      Instructions
      Up