Flucostat - instructions for use, reviews, analogs and form of release (capsules 50 mg, 100 mg and 150 mg, solution) of the drug for treatment of candidiasis (thrush) in adults, children and during pregnancy

In this article, you can read the instructions for using the drug Flucostat. Comments of visitors of the site - consumers of this medication, as well as opinions of specialists on the use of Flucostat in their practice are presented. 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 Flucostat in the presence of existing structural analogues. Use to treat candidiasis (thrush) and other mycoses in adults, children, as well as during pregnancy and lactation.

Flucostat antifungal drug. Fluconazole (active ingredient Flucostat) - a representative of the class of triazole antifungal agents, is a potent selective inhibitor of the synthesis of sterols in the fungal cell.

It is active against pathogens of opportunistic mycoses, incl. caused by Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Also shown is the activity of fluconazole on models of endemic mycoses, including infections caused by Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum.

Pharmacokinetics

After oral administration fluconazole is well absorbed. Simultaneous food intake does not affect absorption during ingestion. Fluconazole well penetrates into all body fluids. The concentrations of fluconazole in saliva and sputum are similar to those in plasma. In patients with fungal meningitis, fluconazole concentrations in the cerebrospinal fluid are about 80% of its levels in the plasma. 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 found in the urine unchanged.

Indications

• cryptococcosis, including cryptococcal meningitis and other localizations of this infection (incl.lungs, skin), as in patients with normal immune response, and in patients with different forms of immunosuppression (including AIDS patients, organ transplantation); the drug can be used to prevent cryptococcal infection in AIDS patients;
• generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infection (including peritoneal, endocardial, eye, respiratory and urinary tract infections). Treatment can be performed in patients with malignant neoplasms, in patients with intensive care units, in patients receiving cytotoxic or immunosuppressive agents, and in the presence of other factors predisposing to the development of candidiasis;
• Candidiasis of mucous membranes, incl. oral and pharyngeal cavities (including atrophic candidiasis of the oral cavity associated with the wearing of dentures), esophagus, non-invasive bronchopulmonary infections, candiduria; prevention of recurrence of oropharyngeal candidiasis in AIDS patients;
• genital candidiasis: treatment of vaginal candidiasis (acute and chronic recurrent), preventive use to reduce the frequency of recurrences of vaginal candidiasis (3 or more episodes a year); Candidiasis balanitis;
• prevention of fungal infections in patients with malignant neoplasms that are predisposed to such infections as a result of cytotoxic chemotherapy or radiation therapy;
• mycosis of the skin, including mycosis of the feet, body, inguinal region, pityriasis, onychomycosis and skin candidiasis;
• Deep endemic mycoses, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.

Forms of release

Capsules 50 mg, 100 mg and 150 mg.

Solution for intravenous administration 2 mg / ml.

Forms of release in the form of tablets or candles do not exist. Medicines in this form may be fakes of Flucostat or its analogues.

Instructions for use and dosing regimen

The drug is taken orally.

Adults with cryptococcal meningitis and cryptococcal infections of other localization on the first day are prescribed 400 mg, and then continue treatment at a dose of 200-400 mg once a day. Duration of treatment for cryptococcal infections depends on clinical efficacy, confirmed by mycological examination; In cryptococcal meningitis, therapy is usually continued for at least 6-8 weeks.

For the prevention of recurrence of cryptococcal meningitis in AIDS patients, 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.

With candidemia, disseminated candidiasis and other invasive candidiasis infections, the average dose is 400 mg on the first day, and then 200 mg per day. With insufficient clinical efficacy, the dose can be increased to 400 mg per day. The duration of therapy depends on clinical effectiveness.

With oropharyngeal candidiasis, the drug is prescribed on average 50-100 mg once a day; the duration of therapy is 7-14 days. If necessary, in patients with a marked decrease in immunity, treatment may be longer.

With atrophic candidiasis of the oral cavity associated with the wearing of dentures, the drug is prescribed at an average dose of 50 mg once a day for 14 days in combination with local antiseptic agents to treat the prosthesis.

With other localizations of candidiasis (with the exception of genital candidiasis), for example, esophagitis, noninvasive bronchopulmonary disease, candiduria, candidiasis of the skin and mucous membranes, the effective dose is on the average 50-100 mg per day with a treatment duration of 14-30 days.

To prevent the recurrence of oropharyngeal candidiasis in AIDS patients, after completion of the full course of primary therapy, fluconazole can be administered 150 mg once a week.

With vaginal candidiasis, fluconazole is taken once inside at a 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 spp., Fluconazole is administered once in a dose of 150 mg orally.

For the prevention of candidiasis, the recommended dose of fluconazole is 50-400 mg once a 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 once daily. Fluconazole is prescribed several days before the expected appearance of neutropenia; after increasing the number of neutrophils more than 1000 / μl, treatment is continued for another 7

With mycosis of the skin, including mycosis of the feet, smooth skin, inguinal area and skin candidiasis, the recommended dose is 150 mg 1 time / week. or 50 mg once a day.The 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, the recommended dose is 300 mg 1 time / week. within 2 weeks; some patients require a third dose of 300 mg / week, while in some cases it is sufficient to take a single dose of the drug at a dose of 300-400 mg. An alternative treatment regimen is the use of the drug 50 mg once a day for 2-4 weeks.

With onychomycosis the recommended dose is 150 mg 1 time / week. Treatment should continue until the replacement of the infected nail (growth of uninfected nail). To re-grow the nails on the fingers and toes, it 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 200-400 mg per day for up to 2 years. The duration of therapy is determined individually and is 11-24 months for coccidioidomycosis, 2-17 months for paracoccidioidomycosis, 1-16 months for sporotrichosis, and 3-17 months for 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 exceeding that of adults. Flucostat is used daily once a day.

In candidiasis of mucous membranes, the recommended dose of fluconazole is 3 mg / kg per day. On the first day, a shock dose of 6 mg / kg may be prescribed to achieve a more rapid equilibrium equilibrium concentration.

For the treatment of generalized candidiasis and cryptococcal infection, the recommended dose is 6-12 mg / kg per 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 radiation therapy, the drug is prescribed at 3-12 mg / kg per 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.

In elderly patients in the absence of violations of kidney function, the drug is used in accordance with the usual dosing regimen.

Side effect

• change in taste;
• nausea;
• flatulence;
• vomiting;
• stomach ache;
• diarrhea;
• headache;
• dizziness;
• convulsions;
• leukopenia, thrombocytopenia, agranulocytosis;
• flicker, flutter of the ventricles;
• skin rash;
• malignant exudative erythema (Stevens-Johnson syndrome);
• toxic epidermal necrolysis (Lyell's syndrome);
• anaphylactoid reactions;
• hypokalemia;
• impaired renal function;
• alopecia.

Contraindications

• simultaneous administration of drugs that extend the QT interval (including terfenadine or astemizole);
• children under 3 years;
• hypersensitivity to the drug or a similar structure of azole compounds.

Application in pregnancy and lactation

The use of Flucostat in pregnancy is possible only in the case of severe and potentially life-threatening fungal infections, when the expected benefit of treatment exceeds the possible risk to the fetus.

Since fluconazole is excreted in breast milk in concentrations close to plasma concentrations, it is not recommended to prescribe the drug during breastfeeding.

special instructions

In rare cases, the use of Flucostat was accompanied by toxic changes in the liver, incl.with a fatal outcome, mainly in patients with serious concomitant diseases. There was no clear dependence of the frequency of hepatotoxic effects of fluconazole on the total daily dose, duration of therapy, sex and age of the patient. The hepatotoxic effect of fluconazole is 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. When a patient who is receiving treatment for a superficial fungal infection, a rash that can be associated with fluconazole, the drug should be discarded. When rashes appear in patients with invasive / systemic fungal infections, fluconazole should be carefully monitored and discarded when bullous lesions or erythema multiforme occur.

Caution should be exercised when using fluconazole simultaneously with cisapride, astemizole, rifabutin, tacrolimus, or other drugs metabolized by isoenzymes of the cytochrome P450 system.

Drug Interactions

When using fluconazole with warfarin, prothrombin time increased by 12%. In this regard, it is recommended to monitor prothrombin time in patients receiving Flucostat in combination with coumarin anticoagulants.

With simultaneous application of fluconazole increases T1 / 2 oral hypoglycemic drugs - derivatives of sulfonylureas (chlorpropamide, glibenclamide, glipizide and tolbutamide). The joint administration of fluconazole and oral hypoglycemic drugs is allowed, but the possibility of developing hypoglycemia should be taken into account.

The simultaneous use of fluconazole and phenytoin may be accompanied by an increase in the concentration of phenytoin in a clinically significant degree. Therefore, when a combined use of these drugs is necessary, monitoring of the concentration of phenytoin with correction of its dose is necessary in order to provide a therapeutic concentration in the blood plasma.

Simultaneous use of Flucostat and rifampicin leads to a 25% decrease in AUC and a 20% decrease in T1 / 2 of fluconazole from the plasma. Therefore, in patients receiving rifampicin simultaneously, a dose of fluconazole is recommended to be increased.

It is recommended that the concentration of cyclosporin in the blood be monitored in patients receiving Flucostat. with the use of fluconazole and cyclosporine 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 blood plasma.

Patients receiving theophylline in high doses, or who are likely to develop theophylline intoxication, should be monitored for the early detection of the symptoms of a theophylline overdose, tk. simultaneous administration of fluconazole leads to a decrease in the average clearance rate of theophylline from plasma.

With the simultaneous use of fluconazole and terfenadine or cisapride, cases of unwanted reactions from the heart, including paroxysms of ventricular tachycardia (pirouette-type arrhythmias) have been described.

There have been reports of an interaction between Flucostat and rifabutin, accompanied by an increase in the 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 are simultaneously receiving rifabutin and fluconazole.

With the simultaneous use of fluconazole and zidovudine, there is an increase in zidovudine in the plasma, which is caused by a decrease in the conversion of the latter into its metabolite.

With the simultaneous use of fluconazole with midazolam, the risk of psychomotor effects increases, with tacrolimus - the risk of nephrotoxicity increases.

Analogues of the drug Flucostat

Structural analogs for the active substance:

• Vero-Fluconazole;
• Disorel-Sanovel;
• Diflason;
• Diflucan;
• Mikonil;
• Medoflucon;
• Mycomomax;
• Mycosyst;
• Mycoflucan;
• Nofung;
• Procanazole;
• Fangifflu;
• Flucosan;
• Flukoside;
• Flukomabol;
• Flucomycid SEDIKO;
• Fluconazole;
• Fluconazole Hexal;
• Fluconazole STADA;
• Fluconazole-Teva;
• Flukonorm;
• Flukoral;
• Flukoreem;
• Forkan;
• Fungolon;
• Ciscan.

Similar medicines:

Other medicines: