Universal reference book for medicines
Product name: FORCAN ® (FORCAN)

Active substance: fluconazole

Type: Antifungal medication

Manufacturer: CIPLA (India)

Composition, form of production and packaging
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Capsules hard gelatinous, size 2, with a light green body and a dark green lid; the contents of the capsules are amorphous powder from white to almost white.
1 caps.

fluconazole 50 mg

Excipients: lactose monohydrate, starch, sodium lauryl sulfate, talc, silicon dioxide colloid.

The composition of the capsule body and cap: gelatin, water, sodium lauryl sulfate, methylparahydroxybenzoate, propylparahydroxybenzoate, indigocarmine, quinoline yellow dye, titanium dioxide.


4 things.
- Strips (1) - packs of cardboard.
?
Capsules hard gelatinous, size 1, with orange body and black lid; the contents of the capsules are amorphous powder from white to almost white.
1 caps.

fluconazole 150 mg

Excipients: lactose monohydrate, starch, sodium lauryl sulfate, talc, silicon dioxide colloid.

The capsule capsule composition: gelatin, water, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, blue diamond dye, crimson dye (Ponso 4R), dye sunset yellow.

The composition of the capsule body: gelatin, water, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, dye sunset yellow,
titanium dioxide.
1 PC.
- Strips (1) - packs of cardboard.
1 PC.
- Strips (2) - packs of cardboard.
1 PC.
- Strips (3) - packs of cardboard.
?
Capsules hard gelatinous, size No. 0, with a dark red body and a black lid; the contents of the capsules are amorphous powder from white to almost white.
1 caps.

fluconazole 200 mg

The capsule capsule composition: gelatin, water, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, blue diamond dye, crimson dye (Ponso 4R), dye sunset yellow.

The composition of the capsule body: gelatin, water, sodium lauryl sulfate, methyl parahydroxybenzoate, propylparahydroxybenzoate, dye azorubin, dye crimson (Ponso 4R), titanium dioxide.

4 things.
- Strips (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Fluconazole, a representative of the class of triazole antifungal agents, is a potent selective inhibitor of the synthesis of sterols in the fungal cell.

The drug is effective in opportunistic fungal infections, incl.
caused by Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Also shown is the activity of fluconazole in endemic mycosis models, including infections caused by Blastomyces dermatitidis, Coccidiodes immitis and Histoplasma capsulatum.
PHARMACOKINETICS

After oral administration fluconazole is well absorbed, its bioavailability is 90%.
C max after ingestion, fasting 150 mg is 90% of the plasma content with internal administration at a dose of 2.5-3.5 mg / l. Simultaneous food intake does not affect the absorption of the drug taken internally. TC max - 0.5-1.5 h after administration, T1/2 fluconazole is about 30 h. Concentrations in the plasma are in direct proportion to the dose. 90% level of equilibrium concentration is reached by 4-5 days of treatment with the drug (with the administration of 1 time / day).
The introduction of a shock dose (on the first day), which is 2 times higher than the usual daily dose, makes it possible to reach a level corresponding to 90% of the equilibrium concentration by the second day.
The apparent volume of distribution approximates the total water content in the body. Binding to plasma proteins - 11-12%.
Fluconazole well penetrates into all body fluids.
Concentrations of the drug in saliva and sputum are similar to those in plasma. In patients with fungal meningitis, the fluconazole content in the cerebrospinal fluid reaches 80% of its plasma level.
In the stratum corneum, epidermis, dermis and sweat fluid, high concentrations are achieved, which exceed the serum levels.

Fluconazole is excreted mainly by the kidneys, approximately 80% of the administered dose is excreted unchanged in the urine.
The clearance of fluconazole is proportional to the creatinine clearance. Metabolites of fluconazole in peripheral blood were not detected.
INDICATIONS

- cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with normal immune response, and in patients with various forms of immunosuppression (including AIDS patients, organ transplantation );
the drug can be used as a supportive therapy for the prevention of cryptococcal infection in AIDS patients;
- generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infections (peritoneal, endocardial, eye, respiratory and urinary tract infections).
Treatment can be performed in patients with malignant neoplasms, in intensive care units, in patients undergoing cytostatic or immunosuppressive therapy, and in the presence of other factors predisposing to the development of candidiasis;
Candidiasis of mucous membranes, incl.
oral and pharyngeal, esophagus, non-invasive bronchopulmonary candidiasis, candiduria, candidiasis of the skin and mucous membranes, as well as atrophic candidiasis of the oral cavity associated with the wearing of dentures (treatment can be performed in patients with normal or decreased immunity function), prevention of recurrence of oropharyngeal candidiasis AIDS patients;
- genital candidiasis: vaginal candidiasis (acute and chronic recurrent), preventive use to reduce the frequency of recurrences of vaginal candidiasis (3 or more episodes a year);
Candidiasis balanitis;
- prevention of fungal infections in patients with malignant neoplasms, which are predisposed to such infections as a result of chemotherapy with cytostatics or radiation therapy;

- mycosis of the skin, including mycosis of the feet, the body, the groin area;
pityriasis lichen; onychomycosis; candidiasis of the skin;
- Deep endemic mycoses, including coccidiomycosis, paracoccidiomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.

DOSING MODE

Adults:

Inside.

In the case of cryococcal meningitis and cryptococcal infections of other localizations, 400 mg are usually prescribed on the first day, and then continue treatment at a dose of 200-400 mg once / day.
The duration of treatment for cryptococcal infections depends on the clinical efficacy, confirmed by mycological examination; in cryptococcal meningitis, it usually lasts at least 6-8 weeks. To prevent the recurrence of cryptococcal meningitis in AIDS patients, after completion of the full course of primary treatment, fluconazole is administered at a dose of 200 mg / day for a long period of time.
With candidemia, disseminated candidiasis and other invasive candidiasis infections, the dose is usually 400 mg on the first day, and then on 200 mg.
With insufficient clinical effectiveness, the dose of the drug can be increased to 400 mg / day. The duration of therapy depends on clinical effectiveness.
With oropharyngeal candidiasis, the drug is usually prescribed at 50-100 mg 1 time / day;
the duration of treatment is 7-14 days. If necessary, in patients with a marked decrease in immunity, treatment may be longer.
In atrophic candidiasis of the oral cavity associated with the wearing of dentures , fluconazole is usually prescribed at 50 mg 1 time / day for 14 days in combination with local antiseptic agents for prosthesis treatment.

For other localizations of candidiasis (with the exception of genital candidiasis), for example, with esophagitis, noninvasive bronchopulmonary disease, candiduria, candidiasis of the skin and mucous membranes, etc., the effective dose is usually 50-100 mg / day with a treatment duration of 14-30 days .
To prevent the recurrence of oropharyngeal candidiasis in AIDS patients after completing the full course of primary therapy, the drug can be prescribed 150 mg once a week.
With vaginal candidiasis, fluconazole is taken once inside at a dose of 150 mg.
To reduce the frequency of recurrences of vaginal candidiasis, the drug can be used at a dose of 150 mg once a month. Duration of therapy is determined individually, it varies from 4 to 12 months. Some patients may need more frequent use.
With balanitis caused by Candida , fluconazole is administered once in a dose of 150 mg orally.

For the prevention of candidiasis, the recommended dose of fluconazole is 50-400 mg 1 time / day, depending on the degree of risk of fungal infection. If there is a high risk of generalized infection, for example, in patients with expected severe or persistent neutropenia, the recommended dose is 400 mg 1 time / day.
Fluconazole is prescribed several days before the expected occurrence of neutropenia, after increasing the number of neutrophils more than 1000 / mm 3, treatment is continued for another 7 days.
In skin mycoses, including foot mycoses, inguinal skin, and skin candidiasis, the recommended dose is 150 mg once a week or 50 mg 1 time / day.
The duration of therapy in usual cases is 2-4 weeks, however, with foot mycoses may require longer therapy (up to 6 weeks).
With pityriasis, the recommended dose is 300 mg once a week for 2 weeks.
Some patients require a third dose of 300 mg per week, while in some cases it is sufficient to receive 300-400 mg once daily. An alternative treatment regimen is the use of the drug at 50 mg once a day for 2-4 weeks.
With onychomycosis, the recommended dose is 150 mg once a week.
Treatment should continue until the replacement of the infected nail (growth of uninfected nail).To re-grow the nails on the fingers and toes, it normally takes 3-6 months and 6-12 months, respectively.
With deep endemic mycoses, it may be necessary to use the drug at a dose of 200-400 mg / day for up to 2 years.
The duration of therapy is determined individually; it can be 11-24 months with coccidiomycosis; 2-17 months with paracoccidiomycosis; 1-16 months with sporotrichosis and 3-17 months with histoplasmosis.
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 that would exceed that of adults. The drug is used daily 1 time / day.
In candidiasis of the mucous membranes, the recommended dose of fluconazole is 3 mg / kg / day. On the first day, a shock dose of 6 mg / kg can be administered to achieve a constant equilibrium concentration.

For treatment of generalized candidiasis or 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 children with reduced immunity, where the risk of infection is associated with neutropenia, resulting from cytotoxic chemotherapy or radiation therapy, the drug is prescribed at 3-12 mg / kg / day, depending on the severity and duration of preservation of induced neutropenia.
In children with impaired renal function, the daily dose of the drug should be reduced (in the same proportional relationship as in adults), according to the degree of renal insufficiency.

In elderly patients in the absence of violations of kidney function should follow the usual dosage regimen.
Patients with renal insufficiency (creatinine clearance less than 50 ml / min) dosage regimen should be adjusted as indicated below.
The use of the drug in patients with impaired renal function

Fluconazole is excreted mainly with urine in unchanged form.
If you do not take it once, you do not need to change the dose. If you repeat the appointment, patients with impaired renal function should first apply a shock dose of 50 mg to 400 mg. If the SC is more than 50 ml / min, the usual dose of the drug (100% of the recommended dose) is used. With SC from 11 to 50 ml / min, a dose equal to 50% of the recommended dose is applied. Patients regularly on dialysis, one dose of the drug prisnjaneksi after each session of hemodialysis.
SIDE EFFECT

On the part of the digestive system: a change in taste, nausea, vomiting, diarrhea, flatulence, abdominal pain, rarely - a violation of liver function (hyperbilirubinemia, increased activity of alanine aminotransferases, aspartate aminotransferase, increased activity of alkaline phosphatase).

From the nervous system: headache, rarely - convulsions, dizziness

On the part of the organs of hematopoiesis: rarely - leukopenia, thrombocytopenia, neutropenia, agranulocytosis.

From the cardiovascular system: an increase in the duration of the QT interval, flicker / flutter of the ventricles.

Allergic reactions: skin rash, rarely - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactoid reactions.

Other: rarely - a violation of kidney function.
Alopecia, hypercholesterolemia, hypertriglyceridemia, hypokalemia.
CONTRAINDICATIONS

- simultaneous administration of cisapride, terfenadine, astemizole and other drugs that extend the QT interval;

- pregnancy, lactation;

- Children under 3 years of age (for this dosage form);

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

With caution : hepatic insufficiency, the appearance of rash against the background of fluconazole in patients with superficial fungal infection and invasive / systemic fungal infections, potentially proaritmogenic states in patients with multiple risk factors (organic heart disease, electrolyte balance disorders, simultaneous use of drugs that cause arrhythmias ).

PREGNANCY AND LACTATION

The use of the drug in pregnant women is inappropriate, except for severe or life-threatening forms of fungal infections, if the expected effect exceeds the possible risk to the fetus.

Fluconazole is found in breast milk in the same concentration as in plasma, so its use during lactation is not recommended.

APPLICATION FOR FUNCTIONS OF THE LIVER

Fluconazole is excreted mainly with urine in unchanged form.
If you do not take it once, you do not need to change the dose. If you repeat the appointment, patients with impaired renal function should first apply a shock dose of 50 mg to 400 mg. If the clearance of creatinine (CC) is more than 50 ml / min, the usual dose of the drug (100% of the recommended dose) is applied. At a QC of 11 to 50 ml / min, a dose equal to 50% of the recommended dose is applied. Patients regularly on dialysis, one dose of the drug prisnjaneksi after each session of hemodialysis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution in liver failure.

APPLICATION FOR CHILDREN

Contraindicated in children under 3 years.
In children, as with similar infections in adults, the duration of treatment depends on the clinical and mycological effect.
APPLICATION IN ELDERLY PATIENTS

In elderly patients in the absence of violations of kidney function should follow the usual dosage regimen.

SPECIAL INSTRUCTIONS

In rare cases, the use of fluconazole was accompanied by toxic changes in the liver, incl.
with a fatal outcome, mainly in patients with serious concomitant diseases. In the case of hepatotoxic effects associated with fluconazole, there was no apparent dependence on the total daily dose, duration of therapy, sex and age of the patient.The hepatotoxic effect of fluconazole was usually reversible; signs of it disappeared after discontinuation of therapy. If there are clinical signs of liver damage that may be associated with fluconazole, the drug should be discontinued.
Patients with AIDS are more likely to develop severe skin reactions with many drugs.
In those cases when the rash develops in patients with superficial fungal infection and it is regarded as definitely associated with fluconazole, the drug should be discontinued. When the rash appears in patients with invasive / systemic fungal infections, they should be carefully monitored and discarded when fluconazole appears or bulimous erythema changes occur. Caution should be exercised while taking fluconazole with rifabutin, tacrolimus, or other drugs metabolized by the cytochrome P450 system.
OVERDOSE

Symptoms: hallucinations, paranoid behavior.

Treatment: symptomatic, gastric lavage, forced diuresis.
Hemodialysis for 3 hours: reduces the plasma concentration by approximately 50%.
DRUG INTERACTION

With the use of fluconazole with warfarin, prothrombin time increases (on average by 12%).
In this regard, it is recommended to carefully monitor the prothrombin time in patients receiving the drug in combination with coumarin anticoagulants.
Fluconazole increases the half-life of plasma oral hypoglycemic agents - sulfonylurea derivatives (chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy people.
The combined use of fluconazole and oral hypoglycemic agents in diabetic patients is permissible, but the doctor should keep in mind the possibility of developing hypoglycemia. The simultaneous use of fluconazole and phenytoin can lead to an increase in the concentration of phenytoin in the plasma to a clinically significant degree. Therefore, when it is necessary to jointly use these drugs, it is necessary to monitor the concentrations of phenytoin with correction of its dose in order to maintain the drug level within the therapeutic interval.
The combination with rifampicin leads to a 25% reduction in AUC and a 20% decrease in the half-life of fluconazole from the plasma.
Therefore, it is advisable to increase the dose of fluconazole to patients receiving rifampicin simultaneously. It is recommended to monitor the concentration of cyclosporine in the blood in patients receiving fluconazole, since fluconazole and cyclosporine in patients with kidney transplantation, the use of fluconazole at a dose of 200 mg / day leads to a slow increase in the concentration of cyclosporine in the plasma.
Patients who receive high doses of theophylline or who are likely to develop theophylline intoxication should be monitored for the early detection of symptoms of theophylline overdose, as taking fluconazole leads to a decrease in the average clearance rate of theophylline from the plasma.

With the simultaneous use of fluconazole and cisapride, cases of unwanted reactions from the heart, including paroxysms of ventricular tachycardia (torsades de points), are described.

There have been reports of an interaction between fluconazole and rifabutin, accompanied by an increase in serum levels of the latter.
With the simultaneous use of fluconazole and rifabutin, cases of uveitis are described. It is necessary to carefully observe patients who are simultaneously receiving rifabutin and fluconazole.
In patients receiving a combination of fluconazole and zidovudine, an increase in the concentration of zidovudine is observed, which is caused by a decrease in the conversion of the latter into its main metabolite, so an increase in the side effects of zidovudine should be expected.

TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

At a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life - 3 years.
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