Fucis - instructions for use, analogs, reviews and release forms (tablets 50 mg, 100 mg, 150 mg and 200 mg, dispersible DT, injections, gel) for the treatment of thrush or candidiasis and other mycoses in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Fucis. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of physicians specialists on the use of Fucis in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Fucis in the presence of existing structural analogs. Use to treat thrush or candidiasis and other mycoses in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Fucis - an antifungal agent of a wide spectrum of action. Fluconazole (active ingredient of the preparation Fucis) is a synthetic derivative of a group of thiazole compounds. Fluconazole, due to the selective effect of fungi on cytochrome P450, results in the loss of enzymatic activity of specific compounds in the fungal cell. As a result, the biosynthesis of sterol compounds in the fungal cell is impaired, in particular, the process of converting lanosterol to ergosterol is inhibited. Ergosterol forms the basis of the cell membrane, and the disruption of its biosynthesis leads to an increase in the permeability and perforation of the cell membrane of the fungus, as a result of which its death occurs. In addition, changes in the cell membrane lead to a violation of the reproduction of fungi due to violation of replication. The drug is effective against most strains of Cryptococcus neoformans (cryptococcus), Microsporum spp. and Trichophytum spp., Coccidioides immitis, Blastomyces dermatitidis, Hystoplasma capsulatum.

 

The drug is highly effective in intracranial infections caused by Coccidioides immitis, Cryptococcus neoformans.

 

Fucis has a high fungicidal activity against Candida spp. (candida), including in generalized forms of infection, which developed against the background of immunodepression.

 

Fucis is low-toxic for the human body, as it has a high selectivity for cytochrome P450 fungi and has an insignificant effect on human cytochromes. Fluconazole in comparison with other antifungal agents of thiazole groups to a lesser extent inhibits cytochrome-dependent processes in the liver. Fluconazole has no significant effect on the amount of androgenic hormones in the blood plasma.

 

Composition

 

Fluconazole + auxiliary substances.

 

Pharmacokinetics

 

After oral administration, the drug is well absorbed in the gastrointestinal tract. Fluconazole has a high bioavailability (more than 90%), food intake does not affect the degree of absorption of the drug. The peak concentration of the active substance in the blood plasma after oral administration is achieved within 30-90 minutes.

 

Plasma concentrations of the drug are directly proportional to the accepted dose of fluconazole. The degree of association with plasma proteins is low (about 10%). Equilibrium concentrations of the drug are noted on the 4-5th day of use (with oral administration of the drug 1 time per day), after taking a shock dose of the drug (the shock dose of fluconazole is equal to two daily), equilibrium concentrations are reached on the second day of treatment.The drug penetrates well into all tissues and body fluids, so high concentrations of fluconazole are noted in saliva, sputum, epidermis and dermis. The drug penetrates well through the blood-brain barrier (BBB), the concentration of fluconazole in the cerebrospinal fluid is about 80% of the plasma concentration.

 

Fluconazole is excreted mainly in urine, both in unchanged form and in the form of metabolites. The clearance of fluconazole is directly proportional to the creatinine clearance. The half-life is about 30 hours.

 

When administered intravenously, the pharmacokinetics of fluconazole does not differ from that in oral administration.

 

Indications

 

Pills

 

Candidiasis of various localization, including:

• Candidemia, Candiduria, disseminated candidiasis, other forms of generalized candidiasis, including infectious diseases of the endocardium, eyes, urinary tract and respiratory system caused by Candida fungus;
• infections of mucous membranes caused by fungi of the genus Candida;
• bronchopulmonary candidiasis non-invasive infections;
• chronic candidiasis of the oral cavity, which is associated with the use of removable dentures;
• treatment of acute and chronic recurrent vaginal candidiasis;
• prevention of recurrence in patients with chronic vaginal candidiasis;
• Candidiasis balanitis;
• cryptococcal infections of various locations, including cryptococcal meningitis;
• treatment of dermatomycosis, mycosis of the inguinal region and feet, onychomycosis, pityriasis lichen;
• treatment of sporotrichosis, histoplasmosis and other endemic mycoses;
• prevention of fungal infections of different locations in patients with immunodeficiency, as well as in patients receiving cytostatic or radiation therapy.

 

Solution for infusion introduction

 

Applied with systemic fungal infections caused by microorganisms that are sensitive to the effects of fluconazole, including:

• Candida, Candiduria, Candida infections of the eyes, endocardium, respiratory and digestive system;
• cryptococcal infections of the skin and respiratory system;
• cryptococcal meningitis.

 

Forms of release

 

Tablets 50 mg, 100 mg, 150 mg and 200 mg.

 

Tablets are dispersible DT 50 mg.

 

Solution for infusion introduction (injections in ampoules for injections).

 

Gel 30 g (sometimes mistakenly called ointment or cream).

 

Instructions for use and dosing regimen

 

Doses of the drug and the duration of the course of treatment are determined by the attending physician depending on the nature of the disease and the individual characteristics of the patient. Doses of the drug do not depend on the method of administration and do not change when passing from parenteral administration to oral administration of Fucis.

 

Fucis tablets containing 50, 100, 150 or 200 mg fluconazole are used to treat adults and children over 7 years of age. Tablets are taken orally regardless of food intake and time of day. Usually the daily dose of the drug is prescribed for 1 reception.

 

Fucis dispersed tablets containing 50 mg of fluconazole are used to treat adults and children over 3 years of age. Before taking the tablet, the tablet is dissolved in a small amount of water (usually 50 mg of fluconazole per 5 ml of water). Usually the daily dose of the drug is prescribed for 1 reception.

 

Solution for infusions Fucis contains 200 mg of fluconazole in 100 ml of isotonic sodium chloride solution. When infusion solution is administered to patients who need to limit the administration of sodium and liquid, it must be taken into account that the content of sodium and chlorine ions in the solution is 15 mmol. The drug is compatible with the following solutions for infusion:

• Ringer's solution;
• glucose solution 20%;
• solution of potassium chloride in glucose;
• solution of sodium chloride 0.9%;
• sodium bicarbonate solution containing 1000 ml of water and 13 g of sodium bicarbonate.

 

The drug is not recommended to be mixed with any solutions for infusions, even if there is no pronounced pharmacological incompatibility.

 

Recommended doses for adults

 

Patients with candidemia and other invasive forms of candidiasis (including disseminated candidiasis) are usually prescribed 400 mg of the drug on the first day, after which the daily dose is reduced to 200 mg. In severe infections, the daily dose of the drug can be increased to 400 mg.

 

Patients with oropharyngeal candidiasis usually appoint 50-100 mg of the drug once a day. The duration of treatment for patients with normal immune status is 1-2 weeks. In patients with reduced immunity, a longer course of treatment is possible.

 

Patients with atrophic candidiasis of the oral mucosa, which is caused by the use of dentures, usually prescribed 50 mg of the drug once a day. The duration of treatment with the drug, while using local antiseptics, is usually 2 weeks.For the prevention of oropharyngeal candidiasis in patients with immunodeficiency, usually prescribed 150 mg of the drug once a week, after the end of primary therapy.

 

Patients with non-invasive infections of mucous membranes, are caused by fungi of the genus Candida (except genital candidiasis form), usually administered 50-100 mg of the drug 1 time per day. The duration of the course of treatment is usually 2-4 weeks.

 

Patients with genital candidiasis usually receive 150 mg of fluconazole in the form of tablets for oral administration once. For the prevention of relapse in patients with chronic vaginal candidiasis, usually prescribed 150 mg of the drug once a month. The duration of preventive use of the drug is from 6 months to 1 year. In candida balanitis, 150 mg of the drug are administered once.

 

For the prevention of generalized candidiasis infection in patients with an increased risk, the drug is administered in a dose of 50 to 400 mg of the drug, depending on the degree of risk of infection. At a risk of developing neutropenia, patients are prescribed 400 mg of the drug 1 time per day a few days before the occurrence of suspected neutropenia.After increasing the concentration of neutrophilic granulocytes to 1000/1 mm3, the preparation should be continued for another 1 week.

 

Patients with cryptococcal infection, including cryptococcal meningitis, are usually prescribed on the first day of treatment 400 mg of the drug once a day, then switch to 200-400 mg of the drug once a day. The duration of the course of treatment of cryptococcal meningitis is usually not less than 1.5-2 months. For the prevention of recurrence after primary therapy in patients with a lowered immune status, the administration of the drug at 200 mg once a day for a long period is prescribed.

 

Patients with fungal skin lesions, including mycosis of the inguinal region and legs, are usually prescribed 150 mg of the drug once a week or 50 mg of the drug once a day. Duration of treatment, depending on the severity of the infection and its location is from 2 weeks to 2 months.

 

Patients with pityriasis are usually prescribed 300 mg of the drug once a week for 2 weeks. However, in some cases, the duration of the course of treatment can be changed. With pityriasis, it can also be recommended to take the drug 50 mg once a day for 14-30 days.

 

Patients with onychomycosis are usually prescribed 150 mg of the drug once a week.The course of treatment is long and depends on the growth rate of the nails, which is individual for each patient. The medication usually lasts from 6 months to 1 year until the sick nail is completely replaced.

 

Patients with deep endemic mycosis are shown taking the drug at a dose of 200-400 mg once a day. The length of the course of treatment depends on the nature of the disease. So, with coccidiomycosis, the duration of the course of treatment is 1-2 years, with paracoccidiomycosis from 2 to 17 months, with histoplasmosis from 3 to 17 months, with sporotrichosis from 1 to 16 months.

 

Older patients with normal renal function do not need dose adjustment.

 

Recommended doses for children older than 7 years

 

Dose of the drug is determined by the attending physician individually. The daily dose of the drug for children should not exceed the dose recommended for the treatment of adults.

 

With candidal infections of the mucous membranes, regardless of location, usually prescribed drug of 3 mg / kg body weight 1 time per day. On the first day, children are prescribed a shock dose of 6 mg / kg of body weight to achieve the equilibrium concentrations of fluconazole as soon as possible in the body.

 

With generalized candidiasis and cryptococcal infections of different localizations, usually 6-12 mg / kg of body weight are prescribed once a day.

 

For the prevention of infectious diseases caused by microorganisms sensitive to the action of fluconazole, in patients with a risk of neutropenia, a drug of 3-12 mg / kg body weight is usually prescribed.

 

The course of treatment with the drug should be continued until negative results of microbiological tests are obtained.

 

Fucis gel is applied externally.

 

Features of Fucis in the form of dispersed tablets

 

When Candida infection of the oral mucosa, including atrophic candidiasis of the oral mucosa, the development of which is associated with the use of dentures, usually appoint 50-100 mg of the drug once a day for 1-2 weeks. The drug is recommended to dissolve in a small amount of water and rinse the mouth for 2 minutes, after which the solution must be swallowed. Patients with a reduced immune status may need a longer course of treatment.

 

With other fungal infections in adults and children, the drug is prescribed according to general recommendations.

 

Features of Fucis in the form of a solution for infusions

 

Adults and children over 3 years of age the drug is prescribed according to general recommendations.

 

Children under 4 weeks of age are prescribed at the same doses as older children, but injected once every 3 days, as the rate of induction is lower in infants than in adults. Children between the ages of 4 weeks to 3 years of age, the drug is prescribed in usual doses, but administered once every 2 days.

 

Side effect

• dizziness;
• headache;
• tremor;
• convulsions;
• a violation of taste sensations;
• arrhythmia;
• tachycardia;
• nausea, vomiting;
• pain in the epigastric region;
• indigestion;
• diarrhea;
• increased concentrations of alkaline phosphatase, hepatic aminotransferases, hyperbilirubinemia;
• the appearance of signs of hepatic insufficiency;
• rarely cases of hepatocellular necrosis and hepatitis;
• exfoliative skin reactions;
• toxic epidermal necrosis;
• alopecia;
• skin rash;
• itching;
• hives;
• angioedema;
• Stevens-Johnson syndrome;
• leukopenia, neutropenia, agranulocytosis, thrombocytopenia;
• hypokalemia;
• increased levels of cholesterol and triglycerides in the blood.

 

Contraindications

• pregnancy;
• lactation;
• for the treatment of children younger than 7 years (tablets), for children under 3 years (tablets dispersible DT);
• Do not apply for treatment of patients receiving terfenadine therapy (with a daily dose of fluconazole over 400 mg) and cisapride;
• It is not recommended to prescribe the drug to patients whose work is related to the management of potentially dangerous mechanisms;
• increased individual sensitivity to the components of the drug and other azole compounds, which are similar in structure to fluconazole.

 

Application in pregnancy and lactation

 

Adequate and controlled studies of the safety of fluconazole in pregnant women have not been conducted. Fucis should be avoided during pregnancy, except in cases of severe and potentially life-threatening fungal infections, when the expected benefit of treatment exceeds the possible risk to the fetus.

 

Women of childbearing age in the period of treatment should use reliable contraception.

 

Fluconazole is determined in breast milk in concentrations close to plasma, so the use during lactation (breastfeeding) is not recommended.

 

Use in children

 

Contraindicated in children under 3 years (tablets dispersible DT), children under 7 years (tablets).

 

special instructions

 

They are used with caution for violations of liver function tests against the use of fluconazole, with the appearance of a rash against the background of fluconazole in patients with superficial fungal infection and invasive / systemic fungal infections, while using terfenadine and fluconazole at a dose of less than 400 mg per day, with potentially proarrhythmic states in patients with multiple risk factors (organic heart disease, electrolyte balance disorders and contributing to the development of such disorders concomitantly therapy).

 

The hepatotoxic effect of fluconazole was usually reversible; signs of it disappeared after discontinuation of therapy. It is necessary to monitor the condition of patients who, during treatment with fluconazole, are disturbed by liver function tests, in order to identify signs of more serious liver damage. If there are clinical signs or symptoms of liver damage that may be associated with fluconazole, it should be discarded.

 

Patients with AIDS are more likely to develop severe skin reactions with many drugs. When a patient who is treated for a superficial fungal infection has a rash that can be associated with fluconazole, it should be discarded. If rashes appear in patients with invasive / systemic fungal infections, fluconazole should be carefully monitored and discarded when bullous lesions or erythema multiforme occur.

 

Simultaneous application of Fucis in doses less than 400 mg per day and terfenadine should be carefully monitored.

 

With fluconazole, an increase in the QT interval and fibrillation / flutter of the ventricles were very rare in patients with multiple risk factors, such as organic heart disease, electrolyte imbalance, and concomitant therapy that promoted the development of such disorders.

 

Therapy can begin before the results of sowing and other laboratory tests. However, anti-infective therapy must be corrected appropriately when the results of these studies become known.

 

There have been reports of cases of superinfection caused by Candida strains other than Candida albicans, which often do not show sensitivity to fluconazole (for example, Candida krusei). In such cases, alternative antifungal therapy may be required.

 

Absorption of the drug does not change depending on food intake or antacid preparations.

 

Drug Interactions

 

With simultaneous use of the drug enhances the effect of anticoagulants. If this combination is necessary, the prothrombin time should be monitored regularly.

 

Fluconazole increases plasma concentrations of midazolam in the blood. Simultaneous administration of Fucis and midazolam for oral administration may lead to the development of psychomotor reactions.

 

When used concomitantly with fluconazole, a dose of benzodiazepine should be reduced. Combine Fucis and benzodiazepine only under the strict supervision of the attending physician.

 

When cisapride is used against the background of fluconazole therapy, there is an increase in the side effects of the latter from the side of the cardiovascular system.Contraindicated at the same time appoint a patient cisapride and fluconazole.

 

An increase in plasma concentrations of cyclosporine is noted when it is used simultaneously with fluconazole. If this combination is necessary, it is recommended to adjust the dose of cyclosporine and regularly monitor its plasma concentrations.

 

Regular use of hydrochlorothiazide against the background of fluconazole therapy leads to a significant increase in plasma concentrations of the latter, however, dose adjustment of fluconazole for patients taking diuretics is not required.

 

There was no decrease in the effectiveness of combined oral contraceptives when they were combined with Fucis.

 

With simultaneous application of fluconazole increases plasma concentrations of rifabutin, which can lead to the development of inflammation of the choroid of the eye.

 

With simultaneous application of fluconazole is able to increase the concentration of phenytoin, therefore, if necessary, such combination, it is necessary to carefully monitor the level of phenytoin and, if necessary, adjust its dose.

 

Fluconazole promotes an increase in the half-life of sulfonylurea preparations (glibenclamide, glipizide, chlorpropamide). When using these drugs in patients with diabetes should take into account the risk of developing hypoglycemia.

 

With the simultaneous use of rifampicin with Fucis, it is necessary to increase the dose of the latter.

 

With the simultaneous use of fluconazole with tacrolimus, there is a mutual increase in nephrotoxicity.

 

With the simultaneous use of theophylline with fluconazole, the risk of developing symptoms of an overdose of theophylline increases, as fluconazole is able to reduce the clearance of theophylline from the blood plasma.

 

Fluconazole is able to increase plasma concentrations of drugs whose metabolism is associated with the cytochrome P450 system.

 

Fluconazole increases plasma concentrations of zidovudine in the blood.

 

Analogues of the drug Fucis

 

Structural analogs for the active substance:

• Disorel of Sanovel;
• Diflason;
• Diflucan;
• Mikonil;
• Medoflucon;
• Mycomomax;
• Mycosyst;
• Mycoflucan;
• Nofung;
• Procanazole;
• Fangifflu;
• Flucosan;
• Flukoside;
• Flukomabol;
• Flucomycid;
• Fluconazole;
• Flukonorm;
• Flukoral;
• Flukorus;
• Flukoreem;
• Flucostat;
• Forkan;
• Fungolon;
• Fucis DT;
• Ciscan.

 

Analogues for the pharmacological group (antifungal agents):

• Amphotericin B;
• Batrafen;
• Bifonazole;
• Bifonazole cream 1%;
• Bifonazole powder 1%;
• Bifonazole solution 1%;
• Vagiphereon;
• Vfend;
• Voriconazole;
• Ginezole 7;
• Gynofort;
• Griseofulvin;
• Dactanol;
• Dermazol;
• Zalain;
• Irunin;
• Itraconazole;
• Itramikol;
• Candide;
• Canison;
• Keto plus;
• Ketoconazole;
• Clindacine B prolong;
• Clion D 100;
• Clotrimazole;
• Lianomik;
• Lamisyl;
• Lamizil Dermgel;
• Levorin;
• Livarol;
• Loceril;
• Metronikon Neo;
• Mikanisal;
• Mikoderil;
• Mikozolone;
• Mycosorrhal;
• Miconazole nitrate;
• Myconorm;
• Mycospores;
• Mycospores Set;
• Mycoterbine;
• Natamycin;
• Neo Penotran;
• Neo-Pentoran Forte;
• Nizoral;
• Nystatin;
• Nitrofungin;
• Orungal;
• Offlomil Luck;
• Perch;
• Pimafucin;
• Rumikoz;
• Safotsid;
• Sertaconazole;
• Sertamicol;
• Terbisyl;
• Terbinafine;
• Fulcin;
• Fungoterbine;
• Exifin;
• Exoderyl;
• Ecofuqin;
• Eraksis.

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