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Diflucan (fluconazole) is an antifungal medicine used to treat infections caused by fungus on any part of the body.
Mechanism of action
The active substance of Diflucan – fluconazole – inhibits the synthesis of sterols in fungal cells. The drug is active against yeast and yeast-like fungi (Candida spp, Cryptococcus neoformans), mold fungi (Histoplasma capsulatum, Blastomyces dermatitides), dermatophytes (Trichophyton spp, Microsporum spp), dimorphic forms (Coccidioides immitis).
The drug is quickly absorbed from the digestive system, reaching a maximum concentration within 0.5-1.5 hours after ingestion, foods do not affect the absorption of fluconazole, the half-life is about 26-30 hours (therefore, it can be used once a day). Fluconazole penetrates well in body fluids and tissues, its concentration in cerebrospinal fluid, saliva and bronchial secretions is almost the same as in blood plasma, and in the stratum corneum, the drug accumulates in doses exceeding the concentration in the blood.
Diflucan does not form active metabolites; it is excreted by the kidneys in an almost unchanged form.
The drug is used to treat the following conditions:
- cryptococcosis, including cryptococcal meningitis and infections of a different location (for example, lungs, skin), including in patients with a normal immune response and in patients with AIDS, recipients of transplanted organs and patients with other forms of immunodeficiency;
- maintenance therapy to prevent relapse of cryptococcosis in AIDS patients;
- generalized candidiasis, including candidaemia, disseminated candidiasis and other forms of invasive candidiasis infection, such as infections of the peritoneum, endocardium, eyes, respiratory and urinary tracts, including in patients with malignant tumors located in the ICU and receiving cytotoxic or immunosuppressive drugs, as well as in patients with other factors predisposing to the development of candidiasis;
- candidiasis of the mucous membranes, including mucous membranes of the oral cavity and pharynx, esophagus, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic atrophic candidiasis of the oral cavity (associated with wearing dentures), including in patients with normal and suppressed immune function; prevention of recurrence of oropharyngeal candidiasis in AIDS patients;
- genital candidiasis;
- acute or recurrent vaginal candidiasis;
- prevention to reduce the recurrence rate of vaginal candidiasis (3 or more episodes per year);
- candida balanitis;
- prevention of fungal infections in patients with malignant tumors predisposed to the development of such infections as a result of cytotoxic chemotherapy or radiation therapy;
- mycoses of the skin, including mycoses of the feet, body, inguinal region, pityriasis versicolor, onychomycosis and skin candidiasis infections;
- deep endemic mycoses in patients with normal immunity, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis.
Do not use Diflucan in the presence of any of the following conditions:
- the simultaneous use of terfenadine during repeated use of fluconazole at a dose of 400 mg/day or more;
- simultaneous use with drugs that increase the QT interval and are metabolized using the CYP3A4 isoenzyme, such as cisapride, astemizole, erythromycin, pimozide and quinidine;
- sucrose/isomalt deficiency, fructose intolerance, glucose-galactose malabsorption (for powder for suspension);
- galactose intolerance, lactase deficiency and malabsorption of glucose/galactose (for capsules);
- children’s age up to 3 years;
- hypersensitivity to fluconazole, other components of the drug or azole substances with a structure similar to fluconazole.
Pregnancy and breastfeeding
Adequate and well-controlled studies of the safety of Diflucan in pregnant women have not been conducted. There are cases of multiple congenital malformations in newborns whose mothers have been treated with fluconazole at a high dose (400-800 mg / day) for coccidioidomycosis. The following developmental disorders were noted: brachycephaly, impaired development of the facial part of the skull, impaired formation of the cranial vault, cleft palate, curvature of the femur, thinning and lengthening of the ribs, arthrogryposis, and congenital heart defects. Currently, there is no evidence of the association of these congenital disorders with the use of fluconazole in low doses (150 mg once for the treatment of vulvovaginal candidiasis) in the first trimester of pregnancy.
Avoid fluconazole during pregnancy, except in cases of severe and potentially life-threatening fungal infections, when the expected benefits treatment exceeds the potential risk to the fetus. Therefore, women of childbearing age should use reliable contraceptives. Fluconazole is found in breast milk in concentrations close to plasma, therefore it is not recommended to use Diflucan during lactation (breastfeeding).
Dosage and administration
Treatment can be started before you get the results of culture and other laboratory tests. However, therapy must be changed accordingly when the results of these studies become known. The daily dose of fluconazole depends on the nature and severity of the fungal infection. With vaginal candidiasis, a single dose of the drug is effective in most cases. In case of infections requiring repeated administration of the antifungal drug, treatment should be continued until the clinical or laboratory signs of fungal infection disappear. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually need maintenance therapy to prevent the recurrence of infection. Adults with cryptococcal meningitis and other cryptococcal infections take an average of 400 mg on the first day, and then continue treatment at a dose of 200-400 mg 1 time/day. The duration of treatment for cryptococcal infections depends on the presence of a clinical and mycological effect; with cryptococcal meningitis, treatment usually lasts at least 6-8 weeks.
Do not exceed recommended doses.
- Nervous system: headache, dizziness, cramps, taste change, paresthesia, insomnia, drowsiness, tremor;
- Digestive system: abdominal pain, diarrhea, flatulence, nausea, dyspepsia, vomiting, dry oral mucosa, constipation, hepatotoxicity (in some cases fatal), increased bilirubin concentration, serum activity of ALT and AST, alkaline phosphatase, impaired liver function, hepatitis, hepatocellular necrosis, jaundice, cholestasis, hepatocellular damage;
- Cardiovascular system: increased QT interval on the ECG, arrhythmia, including ventricular tachysystolic type pirouette;
- Skin: rash, alopecia, exfoliative skin diseases, including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased sweating, drug rash;
- Hemopoietic system: leukopenia, including neutropenia and agranulocytosis, thrombocytopenia, anemia;
- Metabolism: increased plasma cholesterol and triglycerides, hypokalemia;
- Musculoskeletal system: myalgia;
- Allergic reactions: anaphylactic reactions (including angioedema, swelling of the face, urticaria, pruritus).
- Others: weakness, asthenia, fatigue, fever, vertigo. In some patients, especially with serious diseases (AIDS, malignant neoplasms), changes in blood counts, kidney and liver function were observed, however, the clinical significance of these changes and their relationship with treatment have not been established.
An overdose can cause psychomotor reactions. Treatment consists in accelerating the removal of fluconazole from the body by washing the stomach, hemodialysis. Symptomatic therapy is also indicated.
Interaction with other drugs
- Anticoagulants (coumarin series): when used together with warfarin, the prothrombin time may increase, which can lead to bleeding, therefore, when they are prescribed simultaneously, constant monitoring of the coagulogram and prothrombin time is required;
- Hydrochlorothiazide: when these drugs are taken together, they can increase the concentration of fluconazole by 40%, which should be taken into account by the attending physician;
- Benzodiazepines: the simultaneous use of midosolam and fluconazole can lead to an increase in the concentration of benzodiazepine and the development of psychomotor reactions. If joint use is necessary, it is recommended to reduce the dose of Diflucan and carefully monitor the patient’s condition;
- Cisapride: the simultaneous use of Diflucan and Cisapride can cause ventricular arrhythmias, so their combined use is contraindicated;
Cyclosporin: data on co-administration of cyclosporin and Diflucan are contradictory, in some studies an increase in the concentration of cyclosporin was
- observed, in others it was not detected;
- Oral contraceptives: the use of fluconazole in large doses can lead to an increase in the levels of ethinyl estradiol and levonorgestrel;
- Phenytoin: fluconazole can cause an increase in the concentration of phenytoin, so when administered simultaneously, dose adjustment and constant monitoring of the concentration of phenytoin in the blood are required;
- Rifampicin: rifampicin can lead to a decrease in the concentration of fluconazole and its more rapid elimination, so if they are to be taken together, it is recommended to increase the dose of fluconazole;
- Sulfonylurea derivatives: they may be used in conjunction with fluconazole, but the risk of hypoglycemia should be considered;
- Theophylline: fluconazole can lead to an increase in theophylline concentration, therefore, in cases where their simultaneous administration is needed, a dose adjustment of theophylline is required;
- Astemizole: simultaneous administration can take place only with careful monitoring of the level of astemizole in the blood plasma due to the possibility of increasing its concentration;
- Terfenadine: simultaneous administration can cause an extension of the QT interval, which can cause arrhythmias, including fatal ones. The combined use of these drugs is possible only if fluconazole is used in a dose of less than 0.4 g.