Compound
Fucis tablets contain the active substance - fluconazole in various dosages, as well as auxiliary components.
Fucis DT tablets contain 50 mg of fluconazole and excipients.
The composition of the solution for infusion of 100 ml includes: 200 mg of fluconazole and additional components.
The following are used as excipients: microcrystalline cellulose, lactose, povidone K30, magnesium stearate, talc, sodium starch glycolate, sodium croscarmellose and so on.
Fucis gel includes Fluconazole - 5 mg and excipients: carbomer , benzyl alcohol, octyldodecanol, polysorbate 80, propylene glycol, sodium hydroxide, Delite flavor and purified water.
Release form
The drug is available in the form of tablets with a dosage of 50, 100, 150 and 200 mg of the active substance, 4 pcs. in a blister packed in a cardboard box. Fucis tablets 150 mg – 1 pc. in a blister placed in a cardboard package. Dispersed tablets with 50 mg of active ingredient, 4 pcs. in a blister packed in a cardboard box.
Solution for intravenous administration in a 100 ml bottle, one bottle in a cardboard package.
The drug in the form of a gel is offered in a 30 g tube, packed in a cardboard box.
Note!
The description of the drug Fucis on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
Pharmacodynamics and pharmacokinetics
Fluconazole, the active component of this drug, is a synthetic derivative from the group of thiazole compounds. The influence of this substance eliminates the enzymatic activity of specific compounds in fungal cells. As a result, the biosynthesis of sterol compounds in fungal cells is damaged and the conversion of lanosterol to ergosterol . The changes that occur in the cell membrane cause the cessation of fungal reproduction due to replication disorders. At the same time, the effectiveness of Futsis is aimed at such strains as: Coccidioides immitis, Cryptococcus neoformans, Trichophytum spp. and Microsporum spp., Hystoplasma capsulatum, Blastomyces dermatitidis and so on.
Fluconazole is characterized by low toxicity, so the drug does not have a negative effect on the body and does not have a significant effect on human cytochromes and the amount of androgenic hormones in the blood plasma.
Tablets intended for internal use are well absorbed from the gastrointestinal tract. Fluconazole has high bioavailability; eating food does not affect the absorption process. The maximum concentration of the substance in the blood plasma is detected 30-90 minutes after administration.
Good penetration of the substance into tissues and biological fluids was noted. In addition, Fluconazole penetrates the blood-brain barrier, concentrating in the cerebrospinal fluid to 80% of the plasma concentration. Fluconazole is excreted in the urine - some unchanged, the rest as metabolites . The half-life is 30 hours.
The pharmacokinetics of intravenous administration of Fluconazole is practically no different from that taken orally.
The antifungal drug in the form of a gel has the same activity and characteristics as other forms of Fucis. It is especially effective against dermatophytes and yeast.
During external use, only a small amount of the substance enters the blood plasma, so its systemic effect can be excluded. It was also found that the gel does not have a negative effect on the skin.
Pharmacological properties of the drug Fucis
Pharmacodynamics. Antifungal agent of the class of triazole compounds. Fluconazole has a pronounced antifungal effect and specifically inhibits the synthesis of fungal sterols. It has a specific effect on fungal enzymes dependent on cytochrome P450. Active against various strains of Candida spp. (including visceral candidiasis), Cryptococcus neoformans (including intracranial infections), Microsporum spp. and Trichophytum spp. . Fluconazole is also active against pathogens of endemic mycoses: Blastomyces dermatitidis, Coccidioides immitis (including intracranial infections), Hystoplasma capsulatum . Pharmacokinetics. After oral administration, it is well absorbed from the digestive tract, bioavailability exceeds 90%. Eating does not affect the absorption of fluconazole. The maximum concentration in blood plasma is achieved 0.5–1.5 hours after oral administration. The half-life of fluconazole from blood plasma is 30 hours, which allows the drug to be used once a day during a course of treatment with fluconazole and provides a therapeutic effect for vaginal candidiasis after a single dose of the drug. The concentration of the active substance in the blood plasma is directly proportional to the dose taken. 11–12% of fluconazole is bound to plasma proteins. With a daily single dose of fluconazole on days 4–5, a stable concentration in the blood plasma is achieved in 90% of patients. When a loading (twice daily) dose is administered on the 1st day of treatment, the above effect is achieved by the 2nd day of treatment. The pharmacokinetics of fluconazole when administered intravenously is similar to that when administered orally. Fluconazole penetrates well into all body fluids. The level of fluconazole in saliva and sputum is similar to its concentration in blood plasma. In the CSF, the concentration of fluconazole reaches 80% of its concentration in the blood plasma. In the epidermis, dermis, and sweat fluid, a concentration is reached that exceeds the concentration in the blood plasma. Fluconazole is excreted from the body in the urine, 80% unchanged and 11% in the form of metabolites. Fluconazole clearance is directly proportional to creatinine clearance.
Indications for use
The main indications for the use of Futsis is the need for the treatment of infectious diseases of various localizations caused by microorganisms that are sensitive to Fluconazole
Tablets are prescribed for:
- candidal infections of various localizations - candidemia, candiduria, disseminated candidiasis, other forms of generalized candidiasis caused by the Candida fungus;
- infections of the mucous membranes caused by Candida fungi;
- bronchopulmonary candidiasis non-invasive infections ;
- chronic candidiasis associated with wearing removable dentures;
- treatment of acute and chronic forms of recurrent vaginal candidiasis;
- therapy of sporotrichosis, histoplasmosis and other endemic mycoses ;
- treatment of dermatomycosis, mycoses in the groin area and on the feet, onychomycosis and pityriasis versicolor .
Also, tablets can be prescribed to prevent relapses in patients with:
- chronic vaginal candidiasis;
- candidal balanitis;
- cryptococcal infections of various localizations and so on;
- d fungal infections of various localizations, if patients suffer from immunodeficiency or receive cytostatic and radiation therapy.
A solution for infusion is prescribed for the treatment of:
- systemic fungal infections, for example: candidemia, candiduria, candidal infections of the eyes, endocardium ;
- cryptococcal meningitis;
- cryptococcal infections of skin surfaces and respiratory organs.
The gel is used to treat:
- dermatomycosis , which is caused by yeast;
- dermatophytes - athlete's foot, inguinal athlete's foot, trichophytosis, candida infections, pityriasis versicolor.
Special instructions for the use of the drug Fucis
Patients whose liver function tests are impaired during treatment with fluconazole should be under medical supervision. If clinical signs of liver damage appear, fluconazole should be discontinued. People with AIDS are more likely to develop severe skin reactions when taking many drugs. If a rash, possibly caused by the use of fluconazole, appears in a patient receiving treatment for a superficial fungal infection, the drug should be discontinued. With the appearance of a rash in patients with invasive/systemic fungal infections, their condition should be monitored; if polymorphic erythema develops, fluconazole is discontinued. Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy and breastfeeding. The ability to influence the reaction rate when driving vehicles or operating other mechanisms. During treatment with the drug, it is recommended to refrain from driving vehicles and operating other mechanisms.
Side effects
The use of Fucis can cause a number of side effects affecting work:
- nervous system – headache, dizziness, tremor, convulsions;
- cardiovascular system - arrhythmia, tachycardia ;
- liver and gastrointestinal tract - nausea, vomiting, pain, digestive disorders, diarrhea and so on.
Undesirable manifestations on the skin and allergic reactions : alopecia, toxic epidermal necrosis , itching, skin rash, urticaria, swelling, Stevens-Johnson syndrome .
In addition, the use of Fluconazole may affect laboratory parameters : leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hypokalemia, cholesterol and triglyceride levels in the blood.
The occurrence of side effects requires discontinuation of Fucis use.
Instructions for Fucis (Method and dosage)
The drug in tablets containing 50-200 mg of Fluconazole is used in the treatment of adult patients and children over 7 years of age. Take them orally at any time. The daily dosage of the drug is set for one dose.
Fucis DT tablets be pre-dissolved in water. Fucis DT is also approved for children over 3 years old. As a rule, 5 ml of water is used for 50 mg of the drug.
The solution for infusion contains 200 mg of Fluconazole and 100 ml of isotonic sodium chloride solution. When an infusion solution is administered to patients who should limit the administration of fluid and sodium, it is necessary to take into account the content of sodium and chloride ions in this solution, which is 15 mmol. The drug is not recommended to be mixed with any solutions for infusion, despite the absence of pronounced pharmacological incompatibility.
gel instructions for use recommend using it once a day. In this case, the product is gently rubbed into and around the affected areas of the skin.
Apply a small amount of gel and rub it thoroughly over the entire surface to prevent maceration.
The dosage and duration of treatment for each form of the drug is determined by the attending physician. For example, patients suffering from genital candidiasis are prescribed a single dose of 150 mg of Fluconazole tablets. To prevent relapses of chronic vaginal candidiasis - for thrush, 150 mg of this drug is prescribed monthly. This takes into account the nature of the disease and the individual characteristics of the patient. The dosage of the drug does not depend on the method of use and usually does not change when switching from parenteral to oral use.
Use of the drug Fucis
Pills. The daily dose of fluconazole depends on the nature and severity of the fungal infection. Treatment of infections, which involves repeated administration of the drug, should continue until a clinical and laboratory effect is achieved. For candidemia, disseminated candidiasis and other invasive candidal infections, the dose is usually 400 mg on the 1st day, and then 200 mg per day. If necessary, the dose can be increased to 400 mg/day. For oropharyngeal candidiasis, adults are usually prescribed 50–100 mg of fluconazole once a day for 7–14 days. In patients with severe immunosuppression, treatment is continued for a longer period of time if necessary. For atrophic candidiasis of the oral mucosa caused by wearing dentures, the drug is prescribed in a dose of 50 mg once a day for 14 days in combination with local antiseptics for treating the denture. For other candidal infections of the mucous membranes (with the exception of genital candidiasis), for example, esophagitis, non-invasive bronchopulmonary infections, candiduria, candidiasis of the skin and mucous membranes, the effective dose is usually 50-100 mg / day with a treatment duration of 14-30 days. To prevent relapses of oropharyngeal candidiasis in patients with AIDS after completion of the course of primary therapy, fluconazole is prescribed at a dose of 150 mg once a week. For vaginal candidiasis, fluconazole is taken once at a dose of 150 mg orally. To reduce the frequency of relapses of the disease, the drug is taken at a dose of 150 mg once a month. The duration of therapy is determined individually (4–12 months). In some cases, the frequency of appointments is increased. For balanitis caused by fungi of the genus Candida , fluconazole is prescribed orally once at a dose of 150 mg. For the prevention of candidiasis, the recommended dose is 50–400 mg 1 time per day, depending on the degree of risk of developing a fungal infection. If there is a high risk of generalized infection, for example in patients with suspected severe or prolonged neutropenia, the recommended dose is 400 mg once daily. Fluconazole is prescribed several days before the expected onset of neutropenia; after an increase in the number of neutrophil granulocytes over 1000 per 1 mm3, treatment is continued for another 7 days. For cryptococcal meningitis and cryptococcal infections of other localizations, 400 mg is usually prescribed on day 1, and then treatment is continued at a dose of 200–400 mg once a day. The duration of treatment for cryptococcal meningitis is usually continued for at least 6–8 weeks. To prevent relapse of cryptococcal meningitis in patients with AIDS (after completion of the course of primary treatment), therapy with fluconazole at a dose of 200 mg can be continued for a long time. For skin infections, including mycoses of the legs, groin area, and candidal infections, the recommended dose is 150 mg once a week or 50 mg once a day. The duration of therapy is 2–4 weeks, however, with mycosis of the legs, long-term treatment may be required (up to 6 weeks). For pityriasis versicolor, the recommended dose is 300 mg once a week for 2 weeks; some patients need to take a third dose of fluconazole - 300 mg, while in some cases a single dose of 300-400 mg of the drug is sufficient. An alternative treatment regimen is to use the drug 50 mg once a day for 2–4 weeks. For onychomycosis (tinea unguium), the recommended dose is 150 mg once a week. Treatment should be continued until the affected nail is completely replaced with a healthy one. Fingernails and toenails typically take 3–6 and 6–12 months to re-grow, respectively, but the rate of nail growth can vary widely among individuals and also depending on age. In case of deep endemic mycosis, long-term (up to 2 years) use of the drug at a dose of 200–400 mg/day may be necessary. The duration of therapy is determined individually; it is usually 11–24 months for coccidioidomycosis, 2–17 months for paracoccidioidomycosis, 1–16 months for sporotrichosis, and 3–17 months for histoplasmosis. In elderly people in the absence of signs of renal failure, the drug is used in the usual dose. Patients (including children) with impaired renal function with long-term use of the drug are first given a loading dose of 50–400 mg. After administration of the loading dose, the daily dose (depending on the indications) is determined according to the table.
Creatinine clearance (ml/min) | Percentage of recommended dose |
50 | 100 % |
≤ 50 (without dialysis) | 50 % |
Patients who are regularly on dialysis | 100% after every dialysis session |
When switching from intravenous to oral administration or vice versa, there is no need to change the daily dose. For children over 7 years of age, fluconazole is prescribed on the recommendation of a doctor. The daily dose for children should not exceed the dose for adults. For candidiasis of the mucous membranes, the recommended dose of fluconazole for children is 3 mg/kg per day. On day 1, a loading dose of 6 mg/kg is prescribed to more quickly achieve a stable equilibrium concentration. For the treatment of generalized candidiasis and cryptococcal infection, the dose of fluconazole for children is 6–12 mg/kg per day, depending on the course of the disease. For the prevention of fungal infections in patients with reduced immunity, in whom the risk of developing an infection is associated with neutropenia, which develops as a result of chemotherapy or radiation therapy, the drug is prescribed at a dose of 3–12 mg/kg/day, depending on the severity and duration of persistence of induced neutropenia. The duration of treatment with fluconazole in children depends on the results of mycological examination and the clinical picture. Dispersed tablets of 50 mg are used for adults and children over 3 years of age. Dissolve the tablet in 1 teaspoon of water (50 mg/5 ml) or according to the dose. The duration of treatment depends on the clinical and mycological effect. Fucis DT is used every day once a day. For candidiasis of the oral mucosa (rinse and keep in mouth for 2 minutes, then swallow) the usual dose is from 50 to 100 mg 1 time per day for 7-14 days. If necessary, therapy can be extended in patients with immunodeficiency conditions. To prevent relapse of oropharyngeal candidiasis in AIDS patients after a full course of primary therapy, fluconazole can be prescribed at a dose of 150 mg once a week. Esophageal candidiasis - the effective dose is from 50 to 100 mg per day for 14-30 days. Systemic candidal infection and peritonitis - the dose is usually 400 mg on the first day, and then 200 mg per day. Depending on the severity of the clinical effect, the dose can be increased to 400 mg per day. The duration of therapy depends on the clinical effect. Urinary tract infections - the usual effective dose is 50 to 100 mg per day for 14 to 30 days. Cryptococcal meningitis - 400 mg is prescribed on the first day, and then treatment is continued, using doses from 200 to 400 mg once a day. Duration of therapy is 6–8 weeks. In order to prevent recurrence of cryptococcal meningitis in patients with AIDS, after completion of the full course of primary treatment, fluconazole therapy at a dose of 200 mg per day can be continued for a long time. In patients receiving cytostatic or radiation therapy to prevent candidiasis, the recommended dose of fluconazole is 50–400 mg once a day, depending on the degree of risk of developing a fungal infection. If there is a high risk of generalized infection (for example, in patients with suspected severe and prolonged neutropenia), the recommended dose is 400 mg 1 time per day. Fluconazole is prescribed a few days before the expected neutropenia and treatment is continued for another 7 days after the number of neutrophils increases to 1,000 cells per 1 mm3. Children. The daily dose for children should not exceed the dose for adults. For candidiasis of the mucous membranes, the recommended dose is 3 mg/kg body weight per day. For the treatment of generalized candidiasis and cryptococcal infection, the dose of fluconazole for children is 6–12 mg/kg body weight per day, depending on the condition of the disease. For the treatment of cryptococcal infection, the recommended dose of fluconazole for children is 6–12 mg/kg body weight per day, depending on the condition of the disease. Solution for infusions. For adults with candidemia, disseminated candidiasis and other invasive candidiasis, the usual dose is 400 mg on the first day, then 200 mg per day. The daily dose can be increased to 400 mg/day depending on the clinical picture. The duration of the course depends on the patient's condition. For cryptococcal meningitis and other cryptococcal infections, 400 mg is prescribed on the 1st day, then 200–400 mg once a day. The duration of the course depends on clinical and microbiological parameters, and for cryptococcal meningitis - at least 6-8 weeks. Children. For children, as for adults, the dosage and duration of treatment are determined individually, depending on the clinical and microbiological effect. For children, the daily dose should not exceed the maximum dose for adults. For systemic candidiasis or cryptococcal infections, the recommended dose is 7 mg/kg (saturation dose), then a maintenance dose of 3 mg/kg. For cryptococcal meningitis, the dose is doubled. For children with impaired renal function, the daily dose should be reduced according to recommendations for adults. Newborns up to 4 weeks. In the first weeks of life, the drug is prescribed in the same dose (in mg/kg) as for older children, but every 3 days, since the elimination of fluconazole is longer in newborns. For children aged 3–4 weeks, the drug is prescribed in the same dose every 2 days. Elderly patients without impaired renal function can be prescribed the usual dose. In case of renal dysfunction (creatinine clearance ≤40 ml/min), the dose should be reduced. If renal function is impaired, the dose must be reduced depending on the degree of impairment (see table). With continuous therapy, patients with impaired renal function begin treatment with a loading dose of 50–400 mg. Therefore, the frequency of administration or dose varies depending on creatinine clearance, namely:
Creatinine clearance, ml/min | Dosing |
50 | Every 24 hours usual daily dose |
11-50 | Every 48 hours the usual daily dose or every 24 hours half the usual daily dose |
With regular hemodialysis | One daily dose after each dialysis |
When switching from intravenous to oral administration of the drug or vice versa, the daily dose does not change. The daily dose does not depend on the route of administration. 100 ml of infusion solution contains 200 mg of fluconazole in 0.9% sodium chloride solution, in which the content of Na+ or Cl- ions corresponds to 15 mmol. This must be taken into account when treating patients who require sodium or fluid restriction. Fucis in the form of a solution for intravenous infusion is compatible with the following infusion solutions: 20% glucose solution, Ringer's solution, potassium chloride solution in glucose (composition: in 1000 ml of water for injection 3.8 g potassium chloride, 33.75 g anhydrous glucose, 5 g 0.1 N hydrochloric acid), sodium bicarbonate solution (composition: in 1000 ml of water for injection, 13 g sodium bicarbonate), isotonic sodium chloride solution. Despite the absence of pronounced incompatibility, mixing the drug with other infusion solutions is not recommended.
Overdose
In cases of overdose with Fucis tablets or solution, the development of negative symptoms such as headache , dizziness or hallucinations . Also, the occurrence of paranoid behavior in patients should not be ruled out.
In such situations, gastric lavage and other symptomatic therapy are performed. The use of forced diuresis and hemodialysis is allowed.
There are no cases of overdose caused by the use of the drug in gel form.
Interaction
The simultaneous use of Fucis tablets or solution with anticoagulants can significantly enhance their effect. Therefore, regular monitoring of prothrombin time indicators is necessary.
This drug may increase plasma concentrations of midazolam, benzodiazepine, cyclosporine, rifabutin and phenytoin in the blood. When combined with Flucanozole and any of these drugs, strict dosage control and specialist supervision are required. Failure to comply with these rules can cause the development of psychomotor reactions, increase side effects associated with the functioning of the cardiovascular system, and so on. hydrochlorothiazide is regularly used with Fucis, then a noticeable increase in plasma concentrations of Fluconazole can be expected, but no dose adjustment is required.
Taking Fluconazole does not reduce the effect of combined oral contraceptives.
When treating patients with diabetes mellitus , the likelihood of developing hypoglycemia must be taken into account. Concomitant use with rifampicin requires an increase in the dose of Fluconazole. The combination of Fluconazole and Tacrolimus often causes mutual enhancement of nephrotoxicity. When the drug is taken together with theophylline , there is still the possibility of a theophylline , because Fluconazole will help reduce the clearance of theophylline from the blood plasma.
As for Fucis gel, no data on its drug interactions with other drugs are reported. It is recommended to refrain from applying it simultaneously with any external means.
Interactions of the drug Fucis
Patients who are concomitantly using other medications should consult their physician before starting treatment with fluconazole. Fucis enhances the effect of anticoagulants, therefore, when taken simultaneously with coumarin anticoagulants, constant monitoring of prothrombin time is required. With simultaneous administration of midazolam and fluconazole orally, it leads to a significant increase in the concentration of midazolam in the blood plasma and to the occurrence of psychomotor reactions. If a benzodiazepine must be prescribed to a patient receiving fluconazole treatment, the dose of the latter should be reduced and the patient should be closely monitored. With the simultaneous use of fluconazole and cisapride, cases of adverse reactions from the heart have been described, including paroxysmal ventricular tachycardia of the “pirouette” type. Cisapride is contraindicated in patients receiving fluconazole. Fucis increases the concentration of cyclosporine when used simultaneously. When treating with fluconazole, it is recommended to monitor the concentration of cyclosporine in the blood plasma. Repeated use of hydrochlorothiazide leads to an increase in fluconazole plasma concentrations by 40%, but this does not require adjustment of the fluconazole dosage regimen in patients simultaneously using diuretics. Fucis does not affect the effectiveness of combined oral contraceptives. Concomitant use of fluconazole and phenytoin may be accompanied by an increase in phenytoin concentrations to a clinically significant extent. In the case of simultaneous use of these two drugs, it is necessary to monitor the level of phenytoin and adjust its dose to ensure therapeutic concentrations in the blood plasma. As a result of the interaction between fluconazole and rifabutin, the level of rifabutin in the blood plasma increases. Cases of uveitis have been reported with the simultaneous use of fluconazole and rifabutin. When using fluconazole and rifampicin simultaneously, the dose of fluconazole should be increased. Fucis, when taken orally simultaneously with sulfonylureas (chlorpropamide, glibenclamide, glipizide and tolbutamide), increases their half-life. Fucis and oral sulfonylureas can be used simultaneously in patients with diabetes mellitus, but taking into account the possible development of hypoglycemia. Fucis increases the concentration of tacrolimus in the blood plasma. With simultaneous use of fluconazole and tacrolimus, cases of increased nephrotoxicity have been described. For patients using Fucis, terfenadine is contraindicated. When treating patients with fluconazole who use theophylline in high doses, or patients with hypersensitivity to the toxic effects of theophylline, it is necessary to monitor the appearance of symptoms of theophylline overdose, since taking fluconazole reduces the average rate of clearance of theophylline from blood plasma. When used simultaneously with fluconazole and zidovudine, the concentration of the latter in the blood plasma increases significantly. The use of fluconazole simultaneously with astemizole or drugs that are metabolized by the cytochrome P450 system is accompanied by an increase in the concentration of these drugs in the blood plasma. Fucis practically does not change its absorption properties when taken simultaneously with food, cimetidine, and antacids.
Analogs
Level 4 ATC code matches:
Medoflucon
Vfend
Itracon
Mikosist
Irunin
Mikomax
Orungal
Mycoflucan
Fluconazole
Sporagal
Orungamin
Flucostat
Difluzol
Rumicosis
Vero-Fluconazole
Kandizol
Kanditral
Itraconazole
Diflazon
Drugs with a similar effect include: Fluconazole, Clotrimazole, Fukortsin and Livarol.
Reviews about Futsis
This drug is actively used during treatment for thrush . At the same time, many users report that Fucis helps get rid of the disease for many years. Of course, we should not forget about additional therapy that helps restore the normal microflora of the vaginal environment.
However, when using Fucis tablets for thrush , some patients noted the development of side effects . This is usually manifested by swelling, itching of the mucous membranes of the nose and eyes, headache and fever.
Another problem is the independent use of this drug. Without visiting a doctor, patients buy these pills and then ask on forums how to take them for thrush so that the treatment is effective.
about gel are less common, but almost all of them are positive . This remedy is especially helpful in the treatment of ringworm . However, despite the high effectiveness of this drug, before starting treatment you should consult a doctor to choose the optimal dosage and treatment regimen.
Fucis DT 50 mg No. 4 tab.
Instructions for medical use of the drug FUCIS DT Trade name Fucis DT International nonproprietary name Fluconazole Dosage form Dispersible tablets 50 mg Composition One tablet contains the active substance - fluconazole 50 mg, excipients: microcrystalline cellulose, lactose monohydrate, povidone K 30, talc, magnesium stearate , sodium croscarmellose, aerosil, isopropyl alcohol*, sodium saccharin flavoring “American ice cream” DC 129 Description Tablets are white, round, flat-cylindrical in shape with a break line on one side, with the smell of ice cream. Pharmacotherapeutic group Antifungal agents for systemic use. Triazole derivatives. ATC code J02AC01 Pharmacological properties Pharmacokinetics After oral administration, fluconazole is well absorbed, the overall bioavailability is 90%. Concomitant food intake does not affect the absorption of the drug when taken orally. Plasma concentrations reach a peak 0.5-1.5 hours after taking fluconazole on an empty stomach, and the half-life is about 30 hours. Plasma concentrations are proportional to the dose. 90% of equilibrium concentrations are achieved by 4-5 days after the start of therapy (with repeated doses of the drug once a day). Protein binding is low (11-12%). Fluconazole penetrates well into all body fluids. The drug is excreted mainly by the kidneys; approximately 80% of the administered dose is found unchanged in the urine. Fluconazole clearance is proportional to creatinine clearance. No circulating metabolites were detected. Pharmacodynamics Fluconazole, a triazole antifungal agent, is a selective inhibitor of sterol synthesis in fungal cells, is active against infections caused by: - Candida spp., including generalized candidiasis - Cryptococcus neoformans, including intracranial infections - Microsporum spp. - Trychoptyton spp. — Blastomyces dermatitides — Coccidioides immitis — Histoplasma capsulatum Fluconazole has high specificity for fungal enzymes dependent on cytochrome P - 450. Indications for use — cryptococcosis, including cryptococcal meningitis and infections of other localizations (for example, lungs, skin), including . in patients with a normal immune response and patients with AIDS, organ transplant recipients and patients with other forms of immunodeficiency; maintenance therapy to prevent relapses of cryptococcosis in patients with AIDS. - generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis, such as infections of the peritoneum, endocardium, eyes, respiratory and urinary tract, incl. in patients with malignant tumors in intensive care units and receiving cytotoxic or immunosuppressive drugs, as well as in patients with other factors predisposing to the development of candidiasis - candidiasis of the mucous membranes, including the mucous membranes of the mouth and pharynx, esophagus, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic atrophic candidiasis of the oral cavity (associated with wearing dentures), incl. in patients with normal and suppressed immune function; prevention of relapse of oropharyngeal candidiasis in patients with AIDS - genital candidiasis; acute or recurrent vaginal candidiasis; prevention to reduce the frequency of relapses of vaginal candidiasis (3 or more episodes per year); candidal balanitis - prevention of fungal infections in patients with malignant tumors predisposed to such infections as a result of cytotoxic chemotherapy or radiation therapy - mycoses of the skin, including mycoses of the feet, body, groin area, pityriasis versicolor, onychomycosis and skin candidal infections - deep endemic mycoses in patients with normal immunity, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis. Method of administration and dosage Use in adults For cryptococcal meningitis and cryptococcal infections of other localizations, 400 mg is usually prescribed on the first day, and then treatment is continued at a dose of 200-400 mg once a day. The duration of treatment for cryptococcal infections depends on the presence of clinical and mycological effect; For cryptococcal meningitis, treatment is usually continued for at least 6-8 weeks. The recommended dosage of fucis for the prevention of relapse of cryptococcal meningitis in patients with AIDS is 200 mg/day. For candidemia, disseminated candidiasis and other invasive candidal infections, the dose is usually 400 mg on the first day, then 200 mg/day. Depending on the severity of the clinical effect, the dose can be increased to 400 mg/day. The duration of therapy depends on the clinical and mycological effect. For oropharyngeal candidiasis, on the first day the drug is usually prescribed at 200 mg, then continued at 100 mg once a day. Treatment is continued for 2 weeks to reduce the likelihood of relapse. For atrophic oral candidiasis associated with wearing dentures, the drug is usually prescribed at a dose of 50 mg once a day for 14 days in combination with local antiseptics for the treatment of the denture. For other candidal infections of the mucous membranes (with the exception of genital candidiasis, see below), for example, esophagitis, non-invasive bronchopulmonary infections, candiduria, skin candidiasis, the effective dose is usually 50-100 mg / day with a treatment duration of 14-30 days. To prevent relapses of oropharyngeal candidiasis in patients with AIDS after completing the full course of primary therapy, Fucis can be prescribed 150 mg once a week. For vaginal candidiasis, Fucis is prescribed once orally in a dose of 150 mg. To prevent 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. For candidal balanitis, Fucis is prescribed as a single dose of 150 mg orally. For the prevention of fungal infections in patients with malignant tumors, the recommended dose of Fucis is 50-400 mg once a day, depending on the degree of risk of developing a fungal infection. For patients at high risk of generalized infection, for example, with severe or long-lasting neutropenia, the recommended dose is 400 mg once daily. For skin infections, including mycoses of the feet, smooth skin, and groin area, the recommended dose is 150 mg once a week or 50 mg once a day. The duration of therapy is usually 2-4 weeks, however, for mycoses of the feet, longer therapy (up to 6 weeks) may be required. For pityriasis versicolor, the recommended dose is 300 mg once a week for 2 weeks; some patients require a third dose of 300 mg per week, while for some patients a single dose of 300-400 mg is sufficient. An alternative treatment regimen is to use the drug 50 mg once a day for 2-4 weeks. For onychomycosis, the recommended dose is 150 mg once a week. Treatment should be continued until a healthy nail plate appears. Fingernails and toenails usually take 3-6 months to re-grow. and 6-12 months. respectively. However, growth rate can vary widely between individuals and also depending on age. After successful treatment of long-standing chronic infections, a change in the shape of the nails is sometimes observed. For deep endemic mycoses, it may be necessary to use the drug at a dose of 200-400 mg/day. The duration of therapy is determined individually. Use in children As with similar infections in adults, the duration of treatment depends on the clinical and mycological effect. For candidiasis of the mucous membranes, the recommended dose of Futsis from 3 years of age is 3 mg/kg/day. On the first day, in order to more quickly achieve constant equilibrium concentrations, a loading dose of 6 mg/kg can be prescribed. For the treatment of generalized candidiasis and 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 patients with malignant tumors, in whom the risk of developing infection is associated with neutropenia developing as a result of cytotoxic chemotherapy or radiation therapy, the drug is prescribed at 3-12 mg/kg/day, depending on the severity and duration of the induced neutropenia. Use in the elderly In the absence of signs of renal failure, the drug is prescribed at the usual dose. In patients with renal failure (creatinine clearance <50 ml/min), the dose of the drug is adjusted as described below. Use in patients with renal failure With a single dose, no dose change is required. In patients with impaired renal function, with repeated use of the drug, a loading dose of 50 mg to 400 mg should be initially administered, after which the daily dose (depending on the indication) is set according to the following table: Creatinine clearance (ml/min) Percentage of recommended dose >50 ≤ 50 (without dialysis) Regular dialysis 100% 50% 100% after each dialysis Side effects - headache, dizziness, convulsions, changes in taste - nausea, vomiting, abdominal pain, flatulence, diarrhea, dyspepsia - hepatotoxicity, including rare cases with fatal outcome - increased levels of alkaline phosphatase, bilirubin, serum levels of aminotransferases (ALT and AST), increased levels of cholesterol and triglycerides in plasma, hypokalemia - impaired liver function, hepatitis, hepatocellular necrosis, jaundice - rash, alopecia, exfoliative skin diseases, including syndrome Stevens-Johnson and toxic necrolysis of the epidermis - leukopenia, including neutropenia and agranulocytosis, thrombocytopenia - anaphylaxis (including angioedema, facial swelling, urticaria, itching) - increased QT interval on the ECG, ventricular fibrillation/flutter In patients with AIDS or cancer, when treated with Fucis and similar drugs, changes in blood parameters, renal and liver function were observed, but the clinical significance of these changes and their relationship with treatment have not been established. Contraindications - hypersensitivity to fluconazole, other components of the drug or azole substances with a structure similar to fluconazole - simultaneous use of terfenadine during repeated use of fluconazole at a dose of 400 mg / day or more - simultaneous use of cisapride - pregnancy and lactation - children under 3 years of age C caution: Impaired liver function parameters during the use of fluconazole; the appearance of a rash during the use of fluconazole in patients with superficial fungal infection and invasive/systemic fungal infections; simultaneous use of terfenadine and fluconazole at a dose of less than 400 mg/day; potentially proarrhythmic conditions in patients with multiple risk factors (organic heart disease, electrolyte imbalance and concomitant therapy that contributes to the development of such disorders). Drug interactions Fluconazole, when used simultaneously with warfarin, increases prothrombin time (by 12%), and therefore bleeding may develop (hematomas, bleeding from the nose and gastrointestinal tract, hematuria, melena). In patients receiving coumarin anticoagulants, prothrombin time must be constantly monitored. With simultaneous oral use of fluconazole with azithromycin, no pronounced pharmacokinetic interaction has been established between both drugs. Benzodiazepines (short-acting): After oral administration of midazolam, fluconazole significantly increases midazolam concentrations and psychomotor effects, and this effect is more pronounced after fluconazole is administered orally than when fluconazole is administered intravenously. If concomitant benzodiazepine therapy is necessary, patients taking fluconazole should be monitored for a possible benzodiazepine dose reduction. In patients with a transplanted kidney, the use of fluconazole at a dose of 200 mg/day leads to a slow increase in cyclosporine concentrations. However, with repeated doses of fluconazole at a dose of 100 mg/day, no changes in cyclosporine concentrations were observed in bone marrow recipients. When using fluconazole and cyclosporine concomitantly, it is recommended to monitor the concentration of cyclosporine in the blood. Repeated use of hydrochlorothiazide simultaneously with fluconazole leads to an increase in plasma concentrations of fluconazole by 40%. An effect of this severity does not require a change in the dosage regimen of fluconazole in patients receiving concomitant diuretics. With simultaneous use of combined oral contraceptives with fluconazole at a dose of 50 mg, no significant effect on hormone levels has been established. Concomitant use of fluconazole and phenytoin may be accompanied by a clinically significant increase in phenytoin concentrations. If concomitant use of both drugs is necessary, monitor phenytoin concentrations and adjust the dose accordingly to ensure therapeutic serum concentrations. Concomitant use of fluconazole and rifabutin may lead to increased serum concentrations of the latter. Cases of uveitis have been described with the simultaneous use of fluconazole and rifabutin. Patients receiving rifabutin and fluconazole concomitantly should be monitored closely. In patients concomitantly taking rifampicin, it is necessary to consider the advisability of increasing the dose of fluconazole. Concomitant use of oral sulfonylureas and fluconazole leads to an increase in the half-life of sulfonylureas (chlorpropamide, glibenclamide, glipizide and tolbutamide). Patients with diabetes mellitus can be prescribed the combined use of fluconazole and oral sulfonylureas, but the possibility of hypoglycemia should be taken into account. The simultaneous use of fluconazole and tacrolimus leads to increased serum concentrations of the latter. Cases of nephrotoxicity have been described. Patients receiving tacrolimus and fluconazole concomitantly should be monitored closely. With the simultaneous use of azole antifungals and terfenadine, serious arrhythmias may occur as a result of an increase in the QT interval. When taking fluconazole at a dose of 200 mg/day, an increase in the QT interval has not been established; however, the use of fluconazole at doses of 400 mg/day and above causes a significant increase in the concentration of terfenadine in plasma. Concomitant use of fluconazole in doses of 400 mg/day or more with terfenadine is contraindicated. Treatment with fluconazole in doses less than 400 mg/day in combination with terfenadine should be carried out under close monitoring. The simultaneous use of fluconazole and theophylline leads to an increase in serum concentrations of the latter. When prescribing fluconazole to patients taking high doses of theophylline, it is necessary to monitor theophylline concentrations and, if necessary, adjust therapy accordingly. With simultaneous use of zidovudine with fluconazole, an increase in zidovudine concentrations is observed, which is likely due to a decrease in the metabolism of the latter. Patients receiving this combination should be monitored for side effects of zidovudine. The simultaneous use of fluconazole with astemizole or other drugs whose metabolism is carried out by the cytochrome P450 system may be accompanied by an increase in serum concentrations of these drugs. Patients should be monitored carefully. Single or multiple doses of fluconazole at a dose of 50 mg do not affect the metabolism of antipyrine when taken simultaneously. The listed interactions were established with repeated use of fluconazole; There are no known drug interactions resulting from a single dose of fluconazole. Special instructions In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, including death, mainly in patients with serious concomitant diseases. The hepatotoxic effect of Futsis was usually reversible, its signs disappeared after cessation of therapy. Patients whose liver function tests are impaired during treatment with Fucis should be monitored to identify signs of liver damage. If clinical signs or symptoms of liver damage appear that may be associated with the use of fluconazole, the drug should be discontinued. Fucis in rare cases can cause anaphylactic reactions. During treatment with Fucis, patients in rare cases developed exfoliative skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. People with AIDS are more likely to develop severe skin reactions when taking many drugs. If a patient develops a rash during treatment for a superficial fungal infection that can be associated with the use of Fucis, the drug should be discontinued. If a rash appears in patients with invasive/systemic fungal infections, they should be carefully monitored and Fucis should be discontinued if bullous lesions or erythema multiforme appear. Fucis may cause an increase in the QT interval on the ECG. When using Fucis, an increase in the QT interval and ventricular fibrillation/flutter were observed very rarely in seriously ill patients with multiple risk factors, such as organic heart disease, electrolyte imbalances and concomitant therapy that contributes to the development of such disorders. Therefore, Fucis should be used with caution in such patients with potentially proarrhythmic conditions. Patients with liver, heart and kidney diseases are advised to consult a doctor before using Fucis. When using Fucis 150 mg for vaginal candidiasis, patients should be warned that improvement in symptoms is usually observed after 24 hours, but sometimes takes several days for complete disappearance. If symptoms persist for several days, you should consult a doctor. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery. Care should be taken when driving a car or using equipment. Overdose Symptoms: increased side effects. Treatment: symptomatic (including supportive measures and gastric lavage). Fucis is excreted mainly in the urine, so forced diuresis can accelerate the elimination of the drug. Release form and packaging 4 tablets are placed in a blister pack made of polyvinyl chloride film and aluminum foil. 1 blister pack along with instructions for medical use in the state and Russian languages is placed in a cardboard pack. Storage conditions Store in a dry, dark place, at a temperature not exceeding 25 ºС. Keep out of the reach of children! Shelf life: 3 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription Manufacturer Kusum Heltker Pvt. Ltd., SP 289 (A), Riico Indl. Area, Chopanki, Bhiwadi (Raj.), India Name and Country of Marketing Authorization Holder Kusum Heltker Pvt. Ltd., Kazakhstan, the address of the organization receiving in the territory of the Republic of Kazakhstan claims from consumers on the quality of products (goods) Representative Office of the Partnership “Kusum Heltker PVT. LTD. ”, India in the Republic of Kazakhstan of Almaty, st. Tulebaeva, 38 tel/fax: 273-93-74; 273-68-10 email address: [email protected]
Futsis price, where to buy
The price of Fucis 150 mg in Ukraine is about 42 UAH. At the same time, the price of tablets in cities such as Donetsk or Kharkov varies between 40-52 UAH, gel – 60-65 UAH.
In online pharmacies in Moscow, Fucis 150 mg can be ordered at a price of 349 rubles.
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
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For what diseases is Fucis indicated?
- Vaginal candidiasis (thrush).
- Mucosal candidiasis.
- Fungal disease of the esophagus.
- Meningitis of fungal origin.
- Skin fungus.
- Mycosis of the feet, skin, mycosis in the groin area.
- Tinea versicolor.
- Mycosis of the nail plate.
- Candidiasis when wearing dentures in the oral cavity (atrophic candidiasis).
Fucis is also used as a prophylactic against relapses of thrush and meningitis. Prescribed to HIV-infected people to prevent recurrent esophageal fungus and to people with blood cancer to prevent fungal infections.