FLUCOSTAT CAPSULES 50MG

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FLUCOSTAT CAPSULES 50MG - 7PCS

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Composition

Capsules: 1 capsule contains Fluconazole 50 or 150 mg;
Excipients: lactose, corn starch, silica, Magnesium stearate, sodium sulfate;
in a blister strip package 7 (50 mg) or 1 (150 mg) pcs.; in the box 1 pack.

Mechanism of action

Antifungal drug, a triazole derivative. The mechanism of action is associated with the ability to selectively inhibit the synthesis of sterol in the cell of the fungus.
Active against Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp., Blastomyces dermatitidis, Coccidioides immitis, Histoplasma capsulatum.

Suction and distribution
After taking the drug inside, fluconazole is well absorbed from the gastrointestinal tract. Simultaneous food intake does not affect absorption.
Cmax achieved in 0.5-1.5 h after taking the drug on an empty stomach. It penetrates well into all body fluids. Fluconazole is determined in the nails 6 months after completion of therapy. Plasma protein binding is 11-12%.
Removal
No metabolites of fluconazole were detected in the peripheral blood. Fluconazole is excreted by the kidneys (up to 80%). T1/2 - 30 h.

Solution:
- Cryptococcosis: cryptococcal meningitis, cryptococcal infections of the lungs and skin, prevention of recurrence of cryptococcosis in patients with AIDS, organ transplants or in other cases of immunodeficiency;
- Generalized candidosis: candidaemia, disseminated candidosis, and
other forms of invasive candidal infections (infections of the abdominal cavity.
endocardium, eyes, respiratory and urinary tract);
- Candidomycosis of the mucous membranes: oral cavity, pharynx, esophagus and non-invasive
bronchopulmonary infections, candiduria;
- vaginal candidiasis - acute or in chronic recurrent form;
- Prevention of fungal infections in patients with malignant tumors that are predisposed to such infections as a result of Chemotherapy with cytostatics or radiation therapy.

Capsules:
- Cryptococcosis
- Generalized candidiasis, including candidaemia, disseminated candidiasis.The treatment can be carried out in patients receiving immunosuppressive agents.
- Candida mucous membranes, including the oral cavity and pharynx, esophagus,
non-invasive broncho-pulmonary infections. Prevention of candidiasis recurrence
oral cavity in patients with AIDS.
- Genital candidiasis. Vaginal candidiasis (acute or recurrent). Prevention of recurrence of vaginal candidiasis, candidal balanitis.
- Prevention of fungal infections in patients with malignant
diseases during cytotoxic chemotherapy or radiation therapy.
- Mycosis of the skin, including mycoses of the feet, body, inguinal region, scaly
deprive, onychomycosis and candidal lesions of the skin.
- Deep endemic mycoses

Contraindications

- pregnancy;
- lactation;
- hypersensitivity to the drug or similar azole compounds in structure.

Dosage and administration

Fluconazole in the form of injection solution administered intravenously at a rate of not more than 20 mg (10 ml) / min. When translating from intravenous administration to taking capsules and vice versa, there is no need to change the daily dose.
The solution for infusion is compatible with the following solvents: 20% glucose solution, Ringer's solution, Hartman solution, potassium chloride solution in glucose, sodium bicarbonate solution 4.2%, aminofusin, isotonic sodium chloride solution.
Fluconazole infusions can be performed using conventional transfusion kits using one of the above fluids.

Use in adults
With cryptococcal infections The usual dose of fluconazole is 400 mg once a day on the first day of treatment, and then 200-400 mg once a day. The duration of treatment for cryptococcal infections depends on the clinical efficacy confirmed by mycological examination; usually ranges from 6 to 8 weeks.
To prevent the recurrence of cryptococcal meningitis in patients with AIDS after the completion of the full course of primary therapy, fluconazole is prescribed to the patient in doses of at least 200 mg / day for a long period.
  In candidaemia, disseminated candidiasis and other invasive, candidal infections, the daily dose is 400 mg on the first day and 200 mg on the following days. Depending on the clinical efficacy of the drug, the dose may be increased to 400 mg / day.The duration of treatment depends on the clinical effectiveness.
When oropharyngeal candidiasis, including patients with impaired immunity, the usual dose is 50-100 mg once a day for 7-14 days. If necessary, treatment can be extended, especially for severe disorders of the immune system.
  For other candidal infections, for example, for esophagitis, non-invasive bronchopulmonary infections, candiduria, candidiasis of the skin and mucous membranes, the usual daily dose is 50-100 mg for 14-30 days.
For the prevention of fungal infections in patients with malignant neoplasms, the dose of fluconazole should be 50 mg once daily as long as the patient is at increased risk due to cytostatic therapy or radiation therapy.

Use 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 in excess of that in adults. Fluconazole is used daily once a day.
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 depressed immunity, the drug is prescribed at 3-12 mg / kg / day.
Newborns Fluconazole is eliminated more slowly, so in the first two weeks of life the drug is prescribed in the same dose (in mg / kg) as in older children, but with an interval of 72 hours. In children aged 3 and 4 weeks of life, the same dose is administered at intervals of 48 hours.

Use in the elderly
In the absence of impaired renal function should follow the usual recommendations on the dosage of the drug. For patients with impaired renal function (creatinine clearance <50 ml / min), the dosing regimen should be adjusted as indicated below.

Use in patients with renal failure
Fluconazole is excreted mainly in the urine unchanged. With a single dose dose is not required. In patients (including children) with impaired renal function, when you take the drug again, you must initially enter a “shock” dose from 50 mg to 400 mg. After the introduction of the “shock” dose, the daily dose is determined (depending on the indication): when creatinine clearance is more than 50 ml / min, the drug is used in an average dose. When QC from 11 to 50 ml / min, a dose of 50% of the average therapeutic dose is applied.

Capsules apply inside. The daily dose of flucostat depends on the nature and severity of the fungal infection.

400 mg is usually prescribed on the first day, and then continue treatment at a dose of 200-400 mg once a day. The duration of treatment depends on the presence of clinical and mycological effect.
To prevent the recurrence of cryptococcal meningitis in AIDS patients, after completing the full course of primary treatment, therapy with flucostat at a dose of 200 mg / day can be continued for a very long time.
  With disseminated candidiasis and other invasive candidal infections the dose is usually 400 mg on the first day, and then 200-400 mg / day. The duration of therapy depends on the clinical effectiveness.
  For candidiasis of the oral mucosaassociated with the wearing of dental prostheses, the drug is prescribed in a dose of 50 mg once a day for 10-14 days. For other candidal infections of the mucous membranes, 50-100 mg / day is prescribed. within 14-30 days. For the prevention of recurrence of candidiasis of the mucous membranes of the oral cavity and pharynx in AIDS patients after completing the full course of primary treatment, a flucostat can be given 150 mg once a week.
  With vaginal candidiasis and balanitis Flucostat is taken once in a dose of 150 mg. For the prevention of relapse, the drug can be administered once a month at a dose of 150 mg. The duration of therapy is individual:
from 4 to 12 months.
  For the prevention of candidiasis in cancer patients during cytotoxic chemotherapy or radiation therapy, the recommended dose of a flukostat is 50-400 mg once a day. In the presence of high risk
generalized infection the recommended dose is 400 mg once a day, a few days before the expected appearance of neutropenia; after increasing the number of neutrophils more than 1000 / mm3 treatment with flukostatom
continue for another 7 days.
  With mycoses of the skin, including mycoses of the feet, body, groin and candidal infections, the dose is 150 mg once a week or 50 mg once a day. The duration of therapy is 2-4 weeks, with mycoses of the feet - up to 6 weeks. With pityriasis versicolor The recommended dose is 50 mg once daily for 2–4 weeks.
  With onychomycosis The recommended dose is 150 mg once a week. Treatment should be continued until the uninfected nail grows. Normally, it takes 3-6 months to re-grow nails on the fingers and toes. and 6-12 months, respectively.
  With deep endemic mycoses may require the use of the drug in a dose of 200-400 mg / day for up to 2 years.The duration of therapy is determined individually; she is 11-24 months. with coccidiomycosis, 2-17 months. with paracoccidioidomycosis, 1-16 months. with sporotrichosis and 3-17 months. with histoplasmosis.

Children:
In children, as in adults, the dosage and duration of treatment are determined individually depending on the clinical efficacy. Flukostat applied daily once a day. In children, the daily dose should not exceed the maximum daily dose for adults.
  With candidiasis of the mucous membranes 6 mg / kg is prescribed on the first day, and then 3 mg / kg per day.
  For systemic candidiasis or cryptococcosis The recommended dose is 6-12 mg / kg, depending on the severity of the disease.
  For prophylaxis: Children with reduced immunity (depending on the severity of neutropenia) are recommended daily dose of 3-12 mg / kg.

With reduced renal function The daily dose for children should be reduced in accordance with the instructions for adults.

Solution: Headache, nausea, vomiting, diarrhea, flatulence, abdominal pains, hepatic (hepatitis, elevated levels of alkaline phosphatase, bilirubin, serum aminotransferase levels) and / or renal failure, convulsions, alopecia, Stevens-Johnson syndrome, toxic epidermal necrolysis, leukopia, leopopia thrombocytopenia, skin rash, anaphylactoid reactions.

Capsules: Nausea, diarrhea, flatulence, skin rash, Anaphylactic reactions , headache, dizziness are possible when taking flucostat.

The use of the drug during pregnancy is contraindicated.
If necessary, the use of the drug during lactation should stop breastfeeding.

Solution: In rare cases, the use of fluconazole was accompanied by a toxic effect on the liver, including fatal, mainly in patients with serious concomitant diseases. It is necessary to monitor the function of the liver. If there are signs of liver damage that may be associated with taking fluconazole, the drug should be discontinued.

Capsules: Therapy can be started before the results of seeding and other laboratory tests.However, therapy should be adjusted accordingly when the results of these studies are known.
In elderly patients in the absence of renal dysfunction, the usual dosing regimen should be followed.

Patients with impaired renal function with creatinine clearance of more than 50 ml / min, use the usual dose of the drug. For creatinine clearance from 13 to 50 ml / min, a dose of 50% of the therapeutic dose is applied.

In rare cases, there may be a hepatotoxic effect, which passes after stopping the drug. If clinical signs of liver damage appear that may be associated with a flucostat, the drug should be withdrawn.

In rare cases, skin reactions may develop. In cases of rash, flucostat should be canceled.

Treatment: gastric lavage; if necessary, conduct symptomatic therapy. Perhaps the use of forced diuresis.

Anticoagulants: In patients receiving fluconazole and coumarin anticoagulants, careful monitoring of the prothrombin time is necessary because it may increase.
- Sulfonylurea drugs: fluconazole, while taking it, can lengthen the half-life of oral sulfonylurea preparations, therefore, when used together, the possibility of hypoglycemia should be considered.
- Phenytoin: The simultaneous use of fluconazole and phenytoin may be accompanied by an increase in the concentration of phenytoin in a clinically significant degree, which requires a reduction in its dose.
- Rifampicin: If you take rifampicin and fluconazole at the same time, the maximum concentration and half-life of the latter decreases, therefore, if necessary, combined use, you should increase the dose of fluconazole.
- Rifabutin: The combined use of fluconazole and rifabutin is accompanied by an increase in the serum levels of the latter, may develop uveitis.
- Cyclosporine: When combined, the use of fluconazole and cyclosporine is recommended to monitor the concentration of the latter in the blood, since it may increase.
- Terfenadine and astemizol: Given the occurrence of serious life-threatening arrhythmias in patients who received azole antifungal agents in combination with terfenadine or astemizole, their joint use is contraindicated.
- Cisapride: At the same time taking fluconazole and cisapride, cases of adverse reactions to the heart, including paroxysms of ventricular tachycardia, are described. Simultaneous use is contraindicated.
- Zidovudine: When used in combination, it is possible to increase the concentration of zidovudine in the blood plasma. Patients receiving such a combination should be monitored to identify side effects of zidovudine.
- Theophylline: Reception of fluconazole leads to a decrease in the average rate of creatinine clearance from blood plasma, hence the risk of the toxic effect of theophylline and overdose increases.

Although no specific manifestations of pharmaceutical incompatibility are described, it is not recommended to mix the fluconazole solution with solutions of other drugs before the infusion.

When using fluconazole in patients who simultaneously receive other drugs metabolized by the cytochrome P450 system, care must be taken.

Solution: List B. In the dark place at a temperature of +5 ° C to + 30 ° C.
Capsules: In a dry place at a temperature not higher than 25 ° C.

- 2 years.
Pharmacy sales terms
The drug is approved for use as a means of OTC.

Flucostat (fluconazole)

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