Flukonazol таб. 50 mg, 100 mg No. 10
Producer: CJSC Lekhim-Kharkiv Ukraine
Code of automatic telephone exchange: J02AC01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredients: 1 tablet contains: flukonazola of 50 mg, either 100 mg, or 150 mg;
excipients: lactose, potato starch, povidone 25, aerosil, magnesium stearate or stearic acid, gipromeloza, titanium dioxide, talc, polyethyleneglycol, twin 80.
Pharmacological properties:
Antifungal means. Has specific effect on fungal enzymes. It is active concerning various strains of Candida spp. (including visceral candidiasis), Criptococcus neoformans (including intracranial infections), Microsporum spp. and Trichophytum spp. It is active also concerning causative agents of local mycoses: Blastomyces dermatidis, Coccidioides immitis (including intracranial infections), Hystoplasma capsulatum. Therapy flukonazoly does not influence the hormonal status, including the content of sex hormones in blood.
After intake it is well soaked up in a digestive tract. Meal does not influence absorption of a flukonazol. Plasma elimination half-life of blood makes 30 h that allows to use drug of 1 times a day and provides therapeutic effect at vaginal candidiasis after a single dose of drug.
At a daily single dose of a flukonazol for 4-5 days stable concentration it in a blood plasma is reached. At introduction in the 1st day of treatment shock (double daily) a dose the above-stated effect is reached by 2nd day of treatment.
Flukonazol well gets into all liquids of an organism, including into cerebrospinal fluid where its concentration reaches 80% of level in plasma, and also in a corneous layer of nails.
80% - in not changed look are brought out of an organism with urine, and.
Indications to use:
Cryptococcosis: cryptococcal meningitis, cryptococcal infections of lungs and skin, prevention of a recurrence of a cryptococcosis at patients with AIDS; generalized candidiasis; a kandidemiya, the disseminated candidiasis, etc. forms of an invasive candidosis infection (a peritoneum, an endocardium, eyes, respiratory and uric ways); candidiasis of mucous membranes: oral cavities (including the atrophic candidiasis connected with carrying dentures), drinks, a gullet; bronchopulmonary infections; kandiduriya; vaginal candidiasis (acute or recurrent); candidosis balanitis; prevention of fungal infections at patients with the malignant tumors receiving cytotoxic himio-or radiation therapy; skin mycoses: stop, bodies, inguinal area, chromophytosis, onychomycosis, skin candidosis infections; deep local mycoses, including кокцидиомикоз, паракокцидиомикоз, a sporotrichosis and histoplasmosis at patients with normal immunity.
Route of administration and doses:
Drug is used, irrespective of meal, daily, once a day. Duration of treatment depends on a look and localization of the activator and clinical effect and is defined by the doctor individually.
The adult – at cryptococcal infections in the 1st day appoint 400 mg, then 200-400 mg of 1 times a day. Treatment duration – not less than 6-8 weeks. For prevention of a recurrence of cryptococcal meningitis at patients with AIDS use of drug in a dose of 200 mg a day it is possible to continue a long time.
At a kandidemiya, the disseminated candidiasis, invasive candidosis infections in the 1st day the dose makes 400 mg, and then on 200 mg/days. At oropharyngeal candidiasis – on 50-100 mg of 1 times a day within 7-14 days, patients with reduced immunity have a treatment more long. At the atrophic candidiasis of an oral cavity caused by carrying dentures – on 50 mg of 1 times a day within 7-14 days. At other candidosis infections of mucous membranes – 50-100 mg a day, duration of treatment is 14-30 days. For prevention of a recurrence of oropharyngeal candidiasis at patients with AIDS after end of a full course of treatment – on 150 mg once a week.
At vaginal candidiasis – once in a dose of 150 mg. For decrease in frequency of a recurrence drug appoint in a dose 150 mg once a month.
At skin infections, including mycosis of feet, inguinal folds – 150 mg once a week or 50 mg of 1 times a day, treatment duration – 2-4 weeks (at mycoses of feet – to 6 weeks).
At deep local mycoses appoint 200-400 mg a day, it is long, up to 2 years. Duration of therapy is defined individually by the doctor.
To children aged from 1 year up to 16 years drug is appointed only in emergency cases: at superficial candidiases – 1-2 mg on body weight kg a day, at system candidiases and cryptococcoses – 3-6 mg on body weight kg a day.
Features of use:
During treatment you need to make periodically in vitro blood test and urine for control of composition of peripheral blood, function of kidneys and a liver.
It is necessary to avoid use of a flukonazol during pregnancy and feeding by a breast, except for hard cases and potentially life-threatening fungal infections when the estimated advantage for the woman exceeds potential risk for a fruit.
It is improbable that Flukonazol can affect ability to manage vehicles or to work with potentially dangerous mechanisms.
Side effects:
Drug is well transferred. Are possible: a headache, nausea, diarrhea, a meteorism, pain in a stomach. Seldom (is more often at patients with malignant new growths or AIDS) spasms, an alopecia, Stephens-Johnson's syndrome, a toxic epidermal necrolysis, changes of indicators of blood, a leukopenia, thrombocytopenia, skin rash are noted an abnormal liver function and kidneys, however in these cases relationship of cause and effect with administration of drug is not proved.
In case of any undesirable reactions it is necessary to stop use of drug and to see a doctor.
Interaction with other medicines:
Increases effect of anticoagulants of a coumarinic row (increases a prothrombin time), increases concentration in blood of a tsidovudin, cyclosporine, Phenytoinum in clinically significant degree (at simultaneous use monitoring of level of Phenytoinum and correction of its dose is necessary). Increases an elimination half-life of theophylline, peroral gipoglikemeziruyushchy drugs of group of derivatives of sulphonylurea (it is necessary to consider a possibility of development of a hypoglycemia). Hydrochlorthiazidum increases concentration of a flukonazol in a blood plasma (for 40%), rifampicin reduces the period of its semi-removal (by 20%). When using with terfenadiny it is necessary to control an ECG (a possibility of development of arrhythmias).
Contraindications:
Hypersensitivity to the flukonazol or azolny connections close to it on chemical structure; simultaneous use of a terfenadin for the patients receiving therapy flukonazoly in a dose of 400 mg a day or above; pregnancy, a lactation, children's age till 1 year.
Overdose:
At overdose of drug there can be hallucinations and paranoid behavior. In case of overdose it is necessary to stop administration of drug and to call the doctor. The doctor will appoint the corresponding symptomatic treatment (a maintenance therapy and a gastric lavage).
Storage conditions:
It is not necessary to use drug after the termination of the period of validity specified on packaging. In the dry, protected from light place at a temperature not above 30 °C. To store in the place, unavailable to children!
Period of validity - 3 years.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets a dosage of 50 mg and 100 mg or on 2 tablets a dosage of 150 mg in a blister strip packaging.