Capsules " ^{Difluzol ®} " are used for:

• treatment of such diseases at adults as:
  • cryptococcal meningitis;
  • coccidioidosis;
  • invasive candidiases;
  • candidiases of mucous membranes, including candidiasis of a stomatopharynx and candidiasis of a gullet, a kandiduriya, chronic candidiasis of skin and mucous membranes;
  • chronic atrophic candidiasis (the candidiasis caused by use of dentures) at inefficiency of local dental hygienic means;
  • vaginal candidiasis, sharp or recurrent when local therapy is not appropriate;
  • a candidosis balanitis when local therapy is not appropriate;
  • dermatomycoses, including mycosis of feet, mycosis of smooth skin, a pakhovy dermatomycosis, multi-colored deprive also candidosis infections of skin when system therapy is not appropriate;
  • a dermatophyte onychomycosis when use of other medicines is not appropriate;
• prevention of such diseases at adults as:
  • a recurrence of cryptococcal meningitis at patients with high risk of its development;
  • a recurrence of candidiasis of a stomatopharynx or a gullet at patients with HIV with high risk of its development;
  • decrease in frequency of a recurrence of vaginal candidiasis (4 or more cases a year);
  • prevention of candidosis infections at patients with a long neutropenia (for example, patients with malignant diseases of blood which receive chemotherapy or patients at transplantation of haematopoietic stem cells);
• treatment of children: candidiases of mucous membranes (stomatopharynx candidiasis, gullet candidiasis), invasive candidiases, cryptococcal meningitis and for prevention of candidosis infections at patients with reduced immunity (medicament can be used as maintenance therapy for prevention of a recurrence of cryptococcal meningitis at children with high risk of its development).

Structure

Active ingredient: flukonazol (one capsule supports a flukonazol, in terms of 100% substance of 50 mg).

Excipients: calcium stearate, sodium krakhmalglikolit (type A); structure of a cover: gelatin, patent blue V (E 131), quinolinic yellow (E 104), titan dioxide (E 171), azoruby (E 122).

Contraindication

• hypersensitivity to a flukonazol, other azolny connections or to any of medicine excipients;
• simultaneous application of a flukonazol and terfenadin to patients who apply flukonazol repeatedly in doses 400 mg/days and above (according to results of a research of interaction of repeated application);
simultaneous application of a flukonazol and other medicines which extend an interval of QT and are metabolized by
• by means of CYP3A4 enzyme (for example, a tsizaprida, an astemizola, Pimozidum, quinidine and erythromycin).

Route of administration

Daily dose of a flukonazol depends on a look and weight of a fungal infection. For the majority of cases of vaginal candidiasis of rather single use of medicine.

In need of repeated use of medicine before disappearance of clinical and laboratory manifestations of activity of a fungal infection. The insufficient duration of treatment can lead to resuming of active infectious process.

to use Drug, depending on a dosage form, orally or intravenously by infusion. The route of administration of medicine depends on a clinical condition of the patient. There is no need for change of a daily dose of medicine at change of a way of its application from oral on intravenous and vice versa.

Capsule whole. Administration of medicament does not depend on meal.

Adult

Cryptococcosis. Treatment of cryptococcal meningitis: the load dose makes 400 mg in the first day. A maintenance dose - 200-400 mg/days. Treatment duration usually is not less than 6-8 weeks. In infections, life-threatening, it is possible to increase a daily dose to 800 mg. Maintenance therapy for prevention of a recurrence of cryptococcal meningitis at patients with high risk of its development: the recommended dose of medicine makes 200 mg/days during unlimited time.

Coccidioidosis. The recommended dose makes 200-400 mg/days. Duration of treatment is 11-24 months or longer depending on a condition of the patient. For treatment of some forms of an infection, especially for treatment of meningitis, there can be expedient an application of a dose of 800 mg/days.

Invasive candidiases. The load dose makes 800 mg in the first day. A maintenance dose - 400 mg/days. Usually recommended duration of treatment of a kandidemiya is two weeks after the first negative results of culture of blood and disappearance of signs and symptoms of a kandidemiya.

Candidiasis of mucous membranes:

• stomatopharynx candidiasis: the load dose makes 200-400 mg in the first day, a maintenance dose - 100-200 mg/days; duration of treatment is 7-21 days (before achievement of remission), but can be increased for patients with a heavy immunodeficiency;
• gullet candidiasis: the load dose makes 200-400 mg in the first day, a maintenance dose - 100-200 mg/days; duration of treatment is 14-30 days (before achievement of remission), but can be increased for patients with a heavy immunodeficiency;
• kandiduriya: the recommended dose makes 200-400 mg/days within 7-21 days; for patients with a heavy immunodeficiency duration of treatment can be increased;
• chronic atrophic candidiasis: the recommended dose makes 50 mg/days within 14 days;
• chronic candidiasis of skin and mucous membranes: the recommended dose makes 50-100 mg/days; duration of treatment is up to 28 days, but can be increased depending on weight and a type of an infection or decrease in immunity.

Prevention of a recurrence of candidiasis of mucous membranes at patients with HIV which have high risk of its development. Stomatopharynx candidiasis, gullet candidiasis: the recommended dose makes 100-200 mg/days or 200 mg 3 times a week. Duration of treatment is unlimited for patients with suppressed immunity.

Prevention of candidosis infections at patients with a long neutropenia. The recommended dose makes 200-400 mg. Treatment should be begun some days before the expected development of a neutropenia and to continue within 7 days after increase in number of neutrophils more than 1000/mm ³ .

Genital candidiases:

• sharp vaginal candidiasis, candidosis balanitis: the recommended dose makes 150 mg once;
• treatment and prevention of recurrent vaginal candidiases (4 or more cases a year): the recommended dose makes 150 mg of 1 times in 3 days. In total it is necessary to apply 3 doses (1st day, the 4th day and the 7th day). After that it is necessary to apply a maintenance dose of 150 mg within 6 months once a week.

Dermatomycoses:

• mycosis of feet, mycosis of smooth skin, pakhovy dermatomycosis, candidosis infections of skin: the recommended dose makes 150 mg once a week or 50 mg of 1 times a day; duration of treatment is 2-4 weeks (treatment of mycosis of feet can last up to 6 weeks);
multi-colored deprive of
• : the recommended dose makes 300-400 mg within 1-3 weeks once a week;
• dermatophyte onychomycosis: the recommended dose makes 150 mg once a week. Treatment should be continued until on the place of the infected nail grows healthy. Growth of healthy nails on hands and on thumbs of legs requires usually 3-6 months and 6-12 months respectively. However patients can have a different growth rate of nails and depend on age. After successful treatment of long persistent infections the shape of a nail sometimes remains changed.

Children

can Use medicament in the form of capsules of this category of patients when children are capable to swallow safely the capsule, usually it is possible from 5 years.

should not exceed the maximum daily dose of 400 mg.

As well as at similar infections at adults, duration of treatment depends on the clinical and mycologic answer. This medicament is used 1 time a day.

Children since 12 years. Depending on weight and pubertal development the doctor should estimate what dose of medicine (for adults or for children) is optimum for the patient. Clinical data demonstrate that at children the clearance of a flukonazol is higher in comparison with adults. Use of doses of 100, 200 both 400 mg adult and doses of 3, 6 and 12 mg/kg to children leads to achievement of comparable system exposure. The efficiency and safety of use of medicine for treatment of genital candidiases at children are not established, despite exhaustive data on use of medicine to children. If there is a need of use of medicine to children (from 12 to 17 years), it is necessary to apply usual doses to adults.

Children from 5 to 11 years:

• candidiases of mucous membranes: the initial dose makes 6 mg/kg/days, a maintenance dose - 3 mg/kg/days; the initial dose can be applied in the first day for the purpose of faster achievement of equilibrium concentration;
• invasive candidiases, cryptococcal meningitis: the dose of medicine makes 6-12 mg/kg/days depending on severity of a disease;
• maintenance therapy for prevention of a recurrence of cryptococcal meningitis at children with high risk of its development: the dose of medicine makes 6 mg/kg/days depending on severity of a disease;
• prevention of candidiases at patients with an immunodeficiency: the dose of medicine makes 3-12 mg/kg/days depending on expressiveness and duration of the induced neutropenia.

Feature of application

Pregnant

should not apply usual doses of a flukonazol and short-term courses of treatment flukonazoly during pregnancy, except for emergency. It is not necessary to apply high doses of a flukonazol and/or long courses of treatment flukonazoly during pregnancy, except for treatment of infections which potentially threaten life.

Flukonazol gets into breast milk and reaches concentration below, than in blood plasma. Feeding by a breast can be continued after single application of a usual dose of a flukonazol which makes 200 mg or less. It is not recommended to nurse at repeated application of a flukonazol or at application of high doses of a flukonazol.

Drivers

Research of influence of medicine on ability to steer motor transport or to work with other mechanisms. Patsiyentov it is necessary to inform on a possibility of development of dizziness or spasms during use of this medicine. At development of such symptoms it is not recommended to steer motor transport or to work with other mechanisms.

Overdose

was Reported about overdose flukonazoly; at the same time reported about hallucinations and paranoid behavior.

At overdose symptomatic maintenance therapy and in case of need - to wash out a stomach.

with urine; the artificial diuresis can accelerate medicine removal. The session of a hemodialysis lasting 3 hours reduces the level of a flukonazol in blood plasma approximately by 50%.

Side effects

Most often (˃ 1/10) it was reported about such side reactions: headache, abdominal cavity pain, diarrhea, nausea, vomiting, rash, increase in level of alaninaminotranspherase (ALT), aspartate aminotransferase (nuclear heating plant) and alkaline phosphatase of blood.

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 4 years.