Flucostat capsules 150 mg, 1 pc. (Fluconazole)

Latin name

Flucostat

Release Form

Capsules

Packing

1 capsule.

Pharmacological action

Flucostat - antifungal.

Selectively inhibits the synthesis of sterols in the cell wall of fungi.

Pharmacodynamics

Active against Candida spp., Cryptococcus neoformans, Microsporum spp., Trichoptyton spp., Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum.

Pharmacokinetics

When taken orally, it is well absorbed in the digestive tract. Cmax is achieved 0.5–1.5 hours after fasting. It penetrates well into all body fluids, 6 months after completion of therapy it is determined in the nails. It is excreted by the kidneys up to 80%.

After iv administration, fluconazole penetrates well into tissues and body fluids. Concentrations of the drug in saliva and sputum correspond to plasma concentrations. In patients with fungal meningitis, the content of fluconazole in the cerebrospinal fluid reaches 80% of the corresponding plasma levels.

After several injections of 1 dose per day, 90% the level of equilibrium concentration is reached by the 4th – 5th day, with the introduction of the dose on the 1st day, 2 times the usual daily dose, by the 2nd day. The apparent volume of distribution approaches the total volume of water in the body. 11–12% of fluconazole binds to plasma proteins. T1 / 2 - 30 hours.

Excreted by the kidneys 80% unchanged. Fluconazole clearance is directly proportional to creatinine clearance. No metabolites found in peripheral blood.

Indications of

cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with a normal immune response and in patients with various forms of immunosuppression (including in AIDS patients , for organ transplantation) the drug can be used to prevent cryptococcal infection in AIDS patients

generalized candidiasis, including candidaemia, disseminated candidiasis and other forms of invasive candidiasis infections (infections of the peritoneum, endocardium, eyes, respiratory and urinary tracts). Treatment can be carried out in patients with malignant neoplasms, patients in intensive care units, patients undergoing a course of cytostatic or immunosuppressive therapy, as well as in the presence of other factors predisposing to the development of candidiasis

candidiasis of the mucous membranes, including the oral cavity and pharynx (including atrophic candidiasis of the oral cavity associated with the wearing of dentures), the esophagus, non-invasive bronchopulmonary candidiasis, candiduria, skin candidiasis prevention of recurrence of oropharyngeal candidiasis in AIDS patients

genital candidiasis: treatment of vaginal candidiasis, prophylactic use with the goal of reducing the recurrence rate of vaginal candidiasis, candida balanitis

prevention of fungal infections in patients with malignant neoplasms who are predisposed to such infections as a result of chemotherapy with cytostatics or radiation therapy for

mycosis of the skin, including mycosis of the feet, body, inguinal pityriasis, onychomycosis candidiasis of the skin

deep endemic mycosis mycosis mycosis paracoccidiomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.

Contraindications

Hypersensitivity (including to similar azole compounds in structure), simultaneous use of terfenadine, astemizole, cisapride.

Special instructions

In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, including fatal, mainly in patients with serious concomitant diseases.

In the case of hepatotoxic effects associated with fluconazole, there is no obvious dependence on the total daily dose, duration of therapy, gender and age of the patient. The hepatotoxic effect of fluconazole was usually reversible, its signs disappeared after discontinuation of therapy. If there are clinical signs of liver damage that may be associated with fluconazole, the drug should be discontinued.

AIDS patients are more likely to develop severe skin reactions when using many drugs. In cases where a rash develops in patients with superficial fungal infection and is regarded as definitely associated with fluconazole, the drug should be discontinued. When a rash appears in patients with invasive / systemic fungal infections, they should be carefully monitored and fluconazole should be discontinued when bullous changes or erythema multiforme occur.

Caution must be exercised while taking fluconazole with cisapride, rifabutin, or other drugs metabolized by the cytochrome P450 system.

Treatment should be continued until the appearance of clinical and hematological remission, since its premature termination leads to relapse.

Composition

1 capsule contains:

Active ingredient:

fluconazole 150 mg.

Excipients:

silicon dioxide colloidal (aerosil),

corn starch,

magnesium stearate,

sodium lauryl sulfate,

lactose.

Capsule shell composition:

gelatin,

methyl parahydroxybenzoate,

propyl parahydroxybenzoate,

titanium dioxide (E171),

acetic acid.

Dosage and Administration

Inside.

For cryptococcal infections, candidaemia, disseminated candidiasis and other invasive candidiasis infections: on the 1st day - 400 mg, then - 200-400 mg once a day.

For the prevention of relapse of cryptococcal meningitis in AIDS patients after a full course of primary treatment: 200 mg / day for a long period.

For atrophic oral candidiasis associated with wearing dentures: 50 mg once a day for 10-14 days.

For other candidal infections of the mucous membranes: 50–100 mg / day for 14–30 days.

For the prevention of recurrence of oropharyngeal candidiasis in AIDS patients after completing the full course of primary treatment: 150 mg once a week.

For vaginal candidiasis and balanitis: once 150 mg. For the prevention of relapse - 150 mg once a month, for 4-12 months.

For the prevention of candidiasis in cancer patients during cytostatic chemo- or radiation therapy: 50-400 mg once a day. If there is a high risk of developing a generalized infection: 400 mg once a day several days before the expected occurrence of neutropenia after increasing the number of neutrophils by more than 1000 / mm3, treatment is continued for another 7 days.

With skin mycoses (feet, inguinal region, etc.), including candida infections: 150 mg 1 time per week or 50 mg 1 time per day. The duration of therapy is 2-4 weeks, with mycosis of the feet - up to 6 weeks.

With pityriasis versicolor: 50 mg 1 time per day for 2–4 weeks.

For onychomycosis: 150 mg once a week until the growth of an uninfected nail (3–6 and 6–12 months for fingernails and toes, respectively).

For deep endemic mycoses: 200–400 mg / day for 11–24 months (coccidioidomycosis), 2–17 months (paracoccidiomycosis), 1–16 months (sporotrichosis), 3–17 months (histoplasmosis).

Children with candidiasis of the mucous membranes on the 1st day - 6 mg / kg / day, then 3 mg / kg / day, with systemic candidiasis or cryptococcosis - 6-12 mg / kg, depending on the severity of the disease. For prophylaxis against a background of reduced immunity (depending on the severity of neutropenia) - 3-12 mg / kg / day.

Side effects

From the digestive tract: nausea, diarrhea, flatulence.

From the nervous system and sensory organs: headache, dizziness.

Allergic reactions: skin rash, anaphylactic reactions.

Drug interaction

When combined with coumarin anticoagulants, an increase in prothrombin time is possible (it should be controlled), with terfenadine - there is a risk of arrhythmia, cisapride - an increase in adverse reactions from the cardiovascular system, including paroxysmal ventricular tachycardia.

Extends T1 / 2 serum sulfonylureas (increased risk of hypoglycemia).

Increases the concentration of phenytoin, cyclosporine, zidovudine in the blood.

Rifampicin shortens T1 / 2 Flucostat.

overdose

Gastric overdose requires gastric lavage and symptomatic therapy, forced diuresis or hemodialysis (hemodialysis reduces fluconazole concentration by 50% for 3 hours).

Storage conditions

Out of the reach of children at a temperature not exceeding 25 ° C.

Shelf life

2 years.

Deystvuyushtee substance

Fluconazole

Conditions of release from

pharmacies Without prescription

dosage form

capsules

Pharmstandard-Leksredstva, Russia



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