Fangiflu

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Fangiflu: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Fungiflu

ATX code: J02AC01

Active ingredient: fluconazole (Fluconazole)

Producer: Edge Pharma Private, Limited (India)

Description and photo update: 2020-05-03

Fangiflu is an antifungal drug.

Release form and composition

The drug is produced in the form of capsules: No. 2, hard, gelatinous, with a white body and a pink lid, the contents of the capsules are almost white or white powder (1 pc. In blisters, in a cardboard box 1 blister and instructions for use of Fangiflu) …

1 capsule contains:

active substance: fluconazole - 150 mg;
auxiliary components: lactose, colloidal silicon dioxide, starch, sodium lauryl sulfate, magnesium stearate;
capsule shell composition: gelatin, Floxin B dye, titanium dioxide, sunset yellow dye.

Pharmacological properties

Pharmacodynamics

Fangiflu is an antifungal drug. Its active ingredient, fluconazole, is a triazole derivative. It has a highly specific effect due to the ability to inhibit the activity of fungal enzymes that depend on cytochrome P450. By increasing the permeability of the cell membrane, fluconazole disrupts its growth and replication, blocks the process of converting lanosterol of fungal cells into ergosterol.

The high selectivity of fluconazole in relation to fungal cytochrome P450 avoids inhibition of these enzymes in the human body. Unlike itraconazole, clotrimazole, econazole or ketoconazole, it suppresses oxidative processes in human liver microsomes to a lesser extent, which depend on cytochrome P450. Fluconazole has no antiandrogenic activity.

Fangiflu has a therapeutic effect in opportunistic mycoses. Such microorganisms as Microsporum speciales (spp.), Trichophyton spp., Candida spp. Are sensitive to it. (including generalized forms of candidiasis with immunosuppression), Coccidioides immitis and Cryptococcus neoformans (including intracranial infections), Histoplasma capsulatum (including against the background of immunosuppression), Blastomyces dermatitidis (with endemic mycoses).

Pharmacokinetics

After oral administration, fluconazole undergoes a high degree of absorption in the body, bioavailability is 90%. Simultaneous food intake does not affect the rate of its absorption. After taking on an empty stomach at a dose of 150 mg, the maximum concentration (C _max) of fluconazole in plasma is reached after 0.5-1.5 hours. C _max in plasma with oral administration is 90% of that with intravenous (IV) administration of fluconazole, obtained at the rate of 2.5-3.5 mg per 1 kg of patient weight.

Plasma concentration levels are directly dose dependent. Against the background of using the drug once a day, the equilibrium concentration of the active substance (Css) in the blood is reached after 4–5 days of treatment. If a loading dose is taken on the first day, which is 2 times higher than the usual therapeutic daily dose, then by the second day of therapy the level of fluconazole in the blood will correspond to 90% Css.

Plasma protein binding - 11-12%. The volume of distribution practically corresponds to the total water content in the body.

The active substance is able to penetrate well into all body fluids, which makes it possible to achieve a concentration in the joint fluid, saliva, sputum, peritoneal fluid and breast milk, similar to that in plasma. In vaginal secretions, constant values are reached 8 hours after oral administration and remain at this level for 24 hours.

In the treatment of fungal meningitis, the concentration of fluconazole in the cerebrospinal fluid (CSF) is about 85% of the plasma level. Selective accumulation in sweat fluid, stratum corneum and epidermis contributes to the achievement of concentrations in them exceeding the level in serum.

In the stratum corneum after taking the first dose of 150 mg once every 7 days, the concentration is 0.0234 mg / g, and 7 days after taking the second dose - 0.0071 mg / g. In healthy nails after 120 days of therapy at a dose of 150 mg once every 7 days, the concentration of fluconazole is 0.00405 mg / g, in the affected nails - 0.0018 mg / g.

In the liver, fluconazole inhibits the CYP2C9 isoenzyme.

It is excreted mainly through the kidneys: unchanged - 80%, in the form of metabolites - 11%. The half-life (T _1/2) is 30 hours. The clearance of fluconazole is proportional to the clearance of creatinine (CC). The pharmacokinetics of the substance is significantly influenced by the functional state of the patient's kidneys. In this case, there is an inverse relationship between T _1/2 and CC. Within 3 hours of a hemodialysis session, the plasma level of fluconazole decreases by 50%.

Indications for use

acute and recurrent vaginal candidiasis, balanitis;
meningitis, lung and skin infections, sepsis and other systemic lesions caused by Cryptococcus fungi in patients with a normal immune response or various forms of immunosuppression, including AIDS patients (acquired immunodeficiency syndrome) and organ transplantation;
cryptococcal infection in AIDS - for prevention;
generalized candidiasis (treatment and prevention): disseminated candidiasis (damage to the endocardium, respiratory organs, abdominal organs, eyes, urogenital organs) and candidemia - in the presence of factors that contribute to their development, including patients on cytostatic or immunosuppressive therapy;
candidiasis of the mucous membranes of the mouth, pharynx and / or esophagus, mucocutaneous and chronic oral atrophic candidiasis (caused by wearing dentures), candiduria, non-invasive bronchopulmonary candidiasis;
mycoses of the skin of the feet, body, groin, skin candidal infections, onychomycosis, pityriasis versicolor;
deep endemic mycoses in patients with normal immunity, including coccidioidosis, sporotrichosis, histoplasmosis;
fungal infections that develop against the background of the use of chemotherapy or radiation therapy for malignant tumors - for prevention;
relapse of oropharyngeal candidiasis in patients diagnosed with AIDS - for prevention.

Contraindications

Absolute:

simultaneous use of terfenadine when prescribing fluconazole in a daily dose of 400 mg or more;
combination with astemizole, erythromycin, cisapride, pimozide, quinidine, amiodarone;
galactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
breast-feeding;
children and adolescents under 18 years of age;
a history of hypersensitivity to azole antifungal agents;
individual intolerance to the components of the drug.

Fangiflu should be taken with caution in case of impaired renal function, liver failure, potentially proarrhythmogenic conditions in patients with multiple risk factors (electrolyte imbalance, organic heart disease, concomitant therapy with drugs that cause arrhythmias), in case of a rash on the background of the use of fluconazole for treatment superficial fungal infection or invasive (systemic) fungal infections, while taking fluconazole in a daily dose of less than 400 mg and terfenadine, as well as during pregnancy.

Fangiflu, instructions for use: method and dosage

Fangiflu capsules are taken orally, swallowing whole.

The recommended dosage of fluconazole for the treatment of mycoses:

cryptococcal infections, candidemia, disseminated candidiasis and other invasive candidiasis infections: for adult patients - the first dose of 400 mg, then 200–400 mg once a day. The duration of treatment is determined taking into account the clinical condition and mycological reaction. When treating cryptococcal meningitis, the course of therapy should last at least 42 days;
oropharyngeal candidiasis: 50-100 mg once a day for 7-10 days, with immunosuppression - 14 days or more;
atrophic oral candidiasis associated with wearing dentures: 50 mg once a day for 14 days while using local antiseptics to treat the denture;
other candidiasis of the mucous membranes (except for genital candidiasis): 50-100 mg once a day for 14-30 days;
vaginal candidiasis: once - 150 mg. In order to reduce the frequency of relapses, 150 mg should be used once every 30 days, repeating the intake 4-12 times. In some cases, you may need to take Fangiflu more often;
balanitis caused by Candida: single dose - 150 mg;
skin lesions (including mycoses of the feet and skin of the groin), candidiasis: 150 mg 1 time in 7 days or 50 mg 1 time per day. The duration of the course of treatment can be from 14 to 28 days, with mycoses of the feet - up to 42 days;
pityriasis versicolor: 300 mg 1 time in 7 days for 14-21 days. An alternative treatment regimen involves taking Fangiflu at a dose of 50 mg once a day for 14–28 days;
onychomycosis: 150 mg 1 time per 7 days. Reception Fangiflu should be continued until the change of the infected nail (on the fingers a new nail grows within 90-180 days, feet - 180-360 days);
deep endemic mycoses: 200-400 mg per day. The duration of therapy is set individually, the course can be up to 24 months (coccidioidomycosis - 11-24 months, paracoccidioidomycosis - from 2 to 17 months, sporotrichosis - 1-16 months, histoplasmosis - 3-17 months).

Application of Fangiflu to prevent the development of fungal infections:

prevention of candidiasis: 50-400 mg per day. The dose depends on the degree of risk of developing a fungal infection. The drug should be administered a few days before the expected appearance of neutropenia at a daily dose of 400 mg and continue treatment for another 7 days with a neutrophil count of more than 1000 / μl;
prevention of cryptococcal meningitis in AIDS patients: 200 mg per day, long-term;
prevention of recurrence of oropharyngeal candidiasis in AIDS patients after a full primary course of therapy: 150 mg 1 time in 7 days.

In case of fungal diseases in children, dosage forms corresponding to the child's age should be used.

The recommended dosage of fluconazole for the treatment of children:

candidiasis of the mucous membranes, candidiasis of the esophagus: at the rate of 3 mg / kg once a day for 21 days or more;
generalized candidiasis, cryptococcal infections (including meningitis): at the rate of 6–12 mg / kg once a day. The use of the drug is continued until laboratory results are obtained, confirming the absence of pathogens in the cerebrospinal fluid, usually the course lasts 70–84 days;
prevention of fungal infections with reduced immunity, in children with a risk of developing an infection associated with neutropenia due to the use of radiation therapy or cytotoxic chemotherapy: 3–12 mg / kg once a day. The dose is set taking into account the severity and duration of the preservation of induced neutropenia.

The interval between injections of the drug for newborns should be 3 days, for children aged 2-4 weeks - 2 days.

In case of impaired renal function in children, a single dose should be reduced in accordance with the severity of renal failure.

Elderly patients without renal dysfunction do not need dose adjustment.

In chronic renal failure, the loading dose in adults can range from 50 to 400 mg. Patients with CC more than 50 ml / min are shown the appointment of the usual dosing regimen. When CC is 11-50 ml / min, a standard single dose is used with a frequency of administration 1 time in 2 days or ½ of the recommended single dose. Patients on hemodialysis should take the prescribed dose of Fangiflu after each session.

Side effects

Usually Fangiflu demonstrates very good tolerance.

The assessment of the frequency of side effects was given in accordance with the requirements of the WHO (World Health Organization) on the following scale: very often - from 10% or more; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; extremely rarely - less than 0.01%, with an unknown frequency - it is impossible to determine the frequency based on the available data.

According to the results of clinical and post-marketing studies of fluconazole, the following negative side reactions were noted:

from the side of the central nervous system (central nervous system): often - headache; infrequently - drowsiness, change in taste *, convulsions *, insomnia, paresthesia, dizziness *; rarely - tremor;
from the gastrointestinal tract: often - abdominal pain, nausea, vomiting *, diarrhea; infrequently - dryness of the oral mucosa, flatulence, constipation, dyspepsia *;
from the liver, gallbladder and bile ducts: often - increased activity of liver enzymes [ALT (alanine aminotransferase), ACT (aspartate aminotransferase), alkaline phosphatase (alkaline phosphatase)]; infrequently - jaundice *, hyperbilirubinemia, cholestasis; rarely - liver dysfunction *, hepatitis *, hepatocellular damage, hepatocellular necrosis *, hepatotoxicity (including fatal);
dermatological reactions: often - skin rash; infrequently - increased sweating, pruritus, urticaria, drug rash (including persistent); rarely - alopecia, exfoliative dermatitis *, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), facial edema, alopecia *, acute generalized exanthematous pustulosis; with an unknown frequency - DRESS syndrome (drug rash with eosinophilia and systemic manifestations);
on the part of the hematopoietic and lymph organs *: rarely - leukopenia (including agranulocytosis and neutropenia), thrombocytopenia; infrequently - anemia;
from the immune system *: rarely - anaphylactoid reactions (urticaria, facial edema, itching, angioedema and others);
on the part of the cardiovascular system *: rarely - an increase in the QT interval on the electrocardiogram, Torsades de pointes (ventricular tachycardia of the "pirouette" type);
from the side of metabolism *: rarely - hypokalemia, hypercholesterolemia, hypertriglyceridemia;
from the musculoskeletal system: infrequently - myalgia;
other reactions: weakness, fever, increased fatigue, hyperhidrosis, vertigo.

* - data of post-registration observations

In some cases, especially in patients with serious pathologies, such as cancer or AIDS, when taking fluconazole, changes in renal / liver function, as well as blood counts were observed, but today the clinical significance of these transformations and their relationship with therapy have not been established.

Overdose

There was a case of taking fluconazole in a single dose of 8.2 g in a 42-year-old HIV-infected patient. As a result, he displayed paranoid behavior and suffered from hallucinations. After 48 hours, the patient's condition returned to normal.

In case of intoxication with fluconazole, it is recommended to carry out immediate gastric lavage, and then provide the patient with supportive measures (symptomatic treatment).

Since the substance is subject to renal elimination, the use of forced diuresis is likely to accelerate its excretion; A 3-hour hemodialysis session reduces the plasma concentration of fluconazole by about half.

special instructions

Fangiflu treatment should be continued until the results of studies confirming clinical and hematological remission are obtained. A high likelihood of relapse appears in case of premature drug withdrawal.

Taking capsules can be started in the absence of laboratory test results, including sowing, and when they appear, it is recommended to carry out appropriate correction of fungicidal therapy after verification of the diagnosis.

The use of Fangiflu must be accompanied by monitoring the state of the kidney and liver function, blood parameters. The appearance of renal / hepatic failure is the basis for discontinuation of drug treatment. Fluconazole hepatotoxicity is usually reversible.

If, during the treatment of a superficial fungal infection, the patient develops a rash, which may be caused by the use of fluconazole, then the capsules should be canceled.

In cases of rash with invasive or systemic fungal infections, patients should be carefully monitored, and if bullous lesions or erythema multiforme appear, stop taking Fangiflu.

Influence on the ability to drive vehicles and complex mechanisms

Due to the fact that seizures or dizziness may develop while taking Fangiflu, during the period of treatment, patients should be careful when driving and performing other potentially hazardous activities that require increased attention and high speed of psychomotor reactions.

Application during pregnancy and lactation

Adequate and well-controlled studies on the effect of fluconazole on pregnant women have not been conducted.

Nevertheless, there were reports of spontaneous abortions and the development of congenital anomalies in newborns whose mothers in the first trimester of pregnancy were treated with fluconazole at a dose of 150 mg once or repeatedly. Reliable cases of multiple congenital malformations have been described in infants whose mothers received high dose fluconazole (from 400 to 800 mg / day) throughout the first trimester or most of it. Including noted such disorders as brachycephaly, cleft palate, violation of the formation of the cranial vault, pathology of the development of the facial part of the skull, deformity of the femur, arthrogryposis, thinning / lengthening of the ribs, congenital heart defects.

During gestation, the use of Fangiflu should be avoided, except for the treatment of potentially life-threatening severe fungal infections, when the expected benefit to the mother significantly outweighs the potential risk to the fetus. The drug should be taken with caution.

Since fluconazole is found in breast milk in concentrations close to plasma levels, the use of Fangiflu during breastfeeding is contraindicated.

During the course of treatment, women of childbearing age are advised to use reliable contraception.

Pediatric use

The use of Fangiflu for the treatment of children and adolescents under the age of 18 is contraindicated.

With impaired renal function

Caution should be exercised when using Fangiflu in patients with renal insufficiency.

When prescribing the drug to patients with impaired renal function, it is necessary to reduce a single dose, taking into account the severity of renal failure:

CC more than 50 ml / min: shows the appointment of the usual dosing regimen; loading dose in adults - 50-400 mg;
CC 11-50 ml / min: you can use the usual dose 1 time in 2 days or 1/2 of the recommended dose 1 time per day.

With hemodialysis, the antifungal Fangiflu should be taken after the end of the session.

For violations of liver function

Fangiflu should be taken with caution in liver failure.

Use in the elderly

For elderly patients, dose adjustment of Fangiflu is not required if the absence of impaired renal function is established.

Drug interactions

With simultaneous use with Fangiflu:

coumarin anticoagulants: interaction with fluconazole increases the effectiveness of coumarin anticoagulants, therefore, when they are combined, it is necessary to control the prothrombin index. As a result of the combination with warfarin, the prothrombin time increases by an average of 12%;
zidovudine: the level of its concentration of zidovudine increases, increasing the risk of developing its side effects;
cyclosporine: the combination of cyclosporine and fluconazole (200 mg once a day) increases the plasma concentration of cyclosporine in the blood;
rifabutin: with concomitant rifabutin therapy, the risk of uveitis increases;
phenytoin: its concentration in plasma can reach clinically significant indicators, therefore, if necessary, such a combination requires control of the level of phenytoin;
theophylline: T _{1/2 of} theophylline is lengthened, and therefore to reduce the risk of intoxication, its dose must be reduced;
midazolam: the risk of psychomotor effects due to an increase in the concentration of midazolam increases;
tacrolimus: the combination of fluconazole with tacrolimus increases the risk of nephrotoxicity;
glibenclamide, chlorpropamide, glipizide, tolbutamide: the combined use of fluconazole with these hypoglycemic agents leads to an extension of their T _1/2, therefore, concomitant therapy with sulfonylurea derivatives should be accompanied by periodic monitoring of the blood glucose concentration in order to timely correct their doses;
hydrochlorothiazide: increases plasma levels of fluconazole by 40%;
rifampicin: T _{1/2 of} rifampicin decreases by 20% and AUC (area under the concentration-time curve) - by 25%;
terfenadine, cisapride: increase the risk of paroxysmal ventricular tachycardia and other arrhythmias.

Analogs

Fangiflu analogs are Fluconazole, Fluconazole Zentiva, Fluconazole-Sandoz, Fluconazole-Teva, Binnoflunazole, Vero-fluconazole, Disorel-Sanovel, Diflazon, Mikomax, Diflucan, Maykonil, Prokistyst, Mikofluconaz, Fukonoz, Fukonil, Prokoflukon, Flukomak Fluconorm, Flucorus, Flucostat, Forcan, Tsiskan, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Fangiflu

Reviews of Fangiflu are positive. Patients point to the effectiveness of the drug in the treatment of fungal diseases. Many women report that taking one capsule is enough to get rid of vaginal candidiasis (thrush).

The price of Fangiflu in pharmacies

Price for Fangiflu, capsules 150 mg, 1 pc. in the package can be from 146 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!