Flukonazol-Zdorovye, капс. on 50 mg No. 10

General characteristics. Structure:

International and chemical names: fluconazole; a-(2,4-diftorfenit) - a-(1Н-1,2,4-триазол-1-илметил) - 1-N-1,2,4-triazol-1-etanol; main physical and chemical properties: solid gelatin capsules No. 2, the case white opaque and a lid white opaque (for a dosage of 50 mg), a lid yellow opaque and the yellow opaque case (for a dosage of 100 mg), the case green opaque and a lid green opaque (for a dosage of 150 mg). Contents of capsules – powder of white color with a yellowish shade. On the capsule drawing the trademark of the enterprise is allowed; structure: 1 capsule contains a flukonazol in terms of 100% substance of 50 mg, 100 mg or 150 mg;
excipients: sugar milk (lactose), potato starch, polyvinylpirrolidone low-molecular medical, calcium stearate.

Pharmacological properties:

Pharmacodynamics. Flukonazol is the selection inhibitor of synthesis of sterol in a cell of mushrooms. Drug has specific effect on the fungal enzymes dependent on P450 cytochrome. It is active at the mycoses caused by Candida spp. (including visceral candidiasis), Cryptococcus neoformans (including intracranial infections), Microsporum spp., Trichophyton spp., Blastomyces dermatitides, Coccidioides immitis (including intracranial infections), Histoplasma capsulatum.

Pharmacokinetics. After intake it is well soaked up. Meal does not influence absorption of a flukonazol. Bioavailability of drug exceeds 90%. Concentration in a blood plasma reaches the maximum value in 0,5-1,5 h after administration of drug inside. The elimination half-life makes 30 h Flukonazol well gets into all liquids of an organism. In cerebrospinal fluid concentration of a flukonazol reaches 80% of the level of its concentration in a blood plasma. In a corneous layer of skin, epidermis and stalemate liquid the concentration exceeding serumal are reached; флуконазол collects in a corneous layer of skin, in 6 months after completion of therapy drug is defined in nails.
It is removed generally by kidneys; about 80% of the entered dose are found in urine in not changed look. The clearance of drug is proportional to clearance of creatinine.

Indications to use:

Capsules on 50 mg and 100 mg - a cryptococcosis, system candidiasis, candidiasis of mucous membranes, including oral cavities, drinks and a gullet; noninvasive bronchopulmonary infections; kandiduriya; prevention of fungal infections at patients with reduced function of immune system, including at the patients receiving cytostatic or radiation therapy; chromophytosis and skin candidosis infections.
Capsules on 150 mg - vaginal candidiasis, a candidosis balanitis; skin mycoses, including mycoses of feet, bodies, inguinal area, an onychomycosis.

Route of administration and doses:

Inside, daily, 1 time a day. The daily dose of Flukonazola-Zdorovye depends by nature and weights of a fungal infection and is defined individually. Duration of treatment depends on clinical and mycologic effect.
Adults:
at cryptococcal infections in the first day, as a rule, appoint 400 mg, and then continue treatment in a dose of 200-400 mg once a day. Treatment duration, as a rule, makes 6-8 weeks. For prevention of a recurrence of cryptococcal meningitis at patients with AIDS (after end of a full course of primary treatment) therapy of Flukonazolom-Zdorovye in a dose of 200 mg can be continued during very long time;
at candidosis infections the dose makes 400 mg in the first days, then on 200 mg a day, if necessary the dose can be increased to 400 mg a day. Duration of therapy depends on clinical performance;
at oropharyngeal candidiasis – on 50-100 mg once a day within 7-14 days or if necessary – longer time. At atrophic candidiasis of a mucous membrane of an oral cavity usually appoint in a dose 50 mg within 14 days, at other candidosis infections of mucous membranes once a day (except for vaginal candidiasis) the effective dose usually makes 50-100 mg lasting treatment of 14-30 days;
at vaginal candidiasis and a balanitis of Flukonazol-Zdorovye accept once in a dose 150 mg;
for prevention of fungal infections at patients with reduced function of immunity the dose makes 50 mg once a day while the patient treats risk group;
at a skin infection, including mycoses of feet, skin of inguinal area and candidosis infections the recommended dose makes 150 mg once a week or 50 mg once a day. Therapy duration usually makes 2-4 weeks, however at mycoses of feet longer therapy can be required (up to 6 weeks). At a chromophytosis the recommended dose makes 50 mg within 2-4 weeks once a day. At an onychomycosis the recommended dose makes 150 mg once a week. Treatment should be continued before substitution of the infected nail (growth of not infected nail).
Children since 5 years:
at candidiasis of mucous membranes – 3-6 mg on 1 kg of body weight a day, not less than 3 weeks;
at system candidiases – 6-12 mg on 1 kg of body weight a day, within 10-12 weeks (before laboratory confirmation of lack of the activator in liquor).
The daily dose for children should not exceed a dose for adults.
Patients of advanced age:
- in the absence of symptoms of a renal failure drug is used in a usual dose.
Patients with a renal failure:
- at a single dose change of a dose is not required. At repeated reception drug is appointed in an initial dose - from 50 to 400 mg. After that the daily dose (depending on indicators of clearance of creatinine) is determined by the table:

Clearance of creatinine, ml/min.	Percent of the recommended dose
> 50	100%
11–50	50%
The patients who are regularly on dialysis	One dose after each dialysis

Features of use:

It is necessary to appoint drug with care the patient with the expressed abnormal liver functions. Use of drug for children is possible only under control of the doctor. With care appoint to drivers of transport and persons whose work demands exact coordination of movements.

Side effects:

Nausea, abdominal pain, diarrhea, meteorism, headache, dizziness are possible. Allergic reactions: skin rash, anaphylactic reactions. The hepatotoxic effect is possible.

Interaction with other medicines:

At simultaneous use with coumarinic anticoagulants it is necessary to control a prothrombin time; with gipoglikemiziruyushchy means – development of a hypoglycemia is possible; at a combination to rifampicin the dose of Flukonazola-Zdorovye should be increased; at simultaneous use with cyclosporine, a zidovudine increase in their concentration in blood is possible. The concomitant use of Flukonazola-Zdorovye with food, Cimetidinum, antacids does not exert impact on its absorption.

Contraindications:

Hypersensitivity to drug or triazolny connections; pregnancy, lactation; children's age up to 5 years.

Overdose:

Symptoms: nausea, abdominal pain, diarrhea, meteorism, headache, dizziness. Skin rash, anaphylactic reactions can be also observed. Treatment: symptomatic therapy (gastric lavage, maintenance therapy); the artificial diuresis can accelerate drug removal.

Storage conditions:

To store in dry, protected from light and the place, unavailable to children, at a temperature not above 25 °C.
Period of validity – 2 years.

Issue conditions:

According to the recipe

Packaging:

Capsules on 50 mg and 100 mg No. 10; capsules on 150 mg No. 1, No. 1х2, No. 1х3, No. 3 in blister strip packagings.