Fluconazole
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Prices in online pharmacies:
from 12 rubles.
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Fluconazole is an antifungal agent.
Release form and composition
Dosage forms of the drug:
- capsules: hard gelatinous, the colors of the cap and body, the appearance of the contents of the capsules depends on the manufacturer (1, 2, 4, 7, 8, 10, 14, 16, 20, 28 or 40 pcs. in contoured cell packs, polymer bottles, polymer cans, dark glass cans packed in cardboard boxes);
- film-coated tablets: round, biconvex, white with a cream shade or white (at a dose of 50 and 100 mg - 10 pcs., at a dose of 150 mg - 1 or 2 pcs. in PVC / Al blisters foil, 1 package in a cardboard box);
- solution for infusion: slightly colored or colorless transparent liquid (50 or 100 ml in vials or bottles, 1, 2, 5 or 10 vials, 10, 15, 24, 36, 40, 42, 48, 72, 80, 84 or 96 bottles per pack).
1 capsule contains:
- active ingredient: fluconazole - 50, 100 or 150 mg;
- auxiliary components: composition depends on the manufacturer.
1 tablet contains:
- active ingredient: fluconazole - 50, 100 or 150 mg;
- auxiliary components: potato starch, lactose, povidone 25, colloidal silicon dioxide, magnesium stearate;
- film shell: hypromellose, titanium dioxide, polyethylene glycol 6000, talc, polysorbate.
100 ml of solution contains:
- active ingredient: fluconazole - 200 mg;
- auxiliary components: sodium chloride, sodium hydroxide / hydrochloric acid (to adjust the pH), water for injection.
Indications for use
- generalized candidiasis, including candidemia, infections of the endocardium, eyes, abdominal cavity, respiratory and urinary tract, disseminated candidiasis - for the purpose of therapy, including in patients with malignant tumors, in intensive care units, in combination with cytostatic or immunosuppressive therapy, if available other factors predisposing to the development of candidiasis;
- candidiasis of the mucous membranes, including the oral cavity and pharynx, including atrophic candidiasis of the oral cavity due to wearing dentures, esophageal candidiasis, non-invasive bronchopulmonary candidiasis, skin candidiasis, candiduria and urinary tract candidiasis; for the prevention of recurrent oropharyngeal candidiasis in patients with AIDS;
- genital candidiasis: vaginal candidiasis (chronic recurrent and acute), candidal balanitis; for prophylaxis in order to reduce the frequency of relapses of vaginal candidiasis (with 3 or more episodes per year);
- cryptococcosis (Cryptococcus neoformans) of various localization (lungs, skin, etc., including cryptococcal meningitis) both in patients with a normal immune response and in immunosuppressive conditions as a result of AIDS, organ transplantation, etc.; can be used to prevent cryptococcal infection in AIDS patients;
- fungal infections in patients with malignant tumors, predisposed to such infections as a result of radiation or chemotherapy with cytostatics - for the purpose of prevention;
- mycoses of the skin (including mycoses of the body, groin, feet), candidiasis of the skin, onychomycosis, pityriasis versicolor;
- deep endemic systemic mycoses, such as paracoccidioidomycosis, coccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity;
- candidiasis in the presence of a high risk of generalized infection, for example, in patients with neutropenia (severe or long-term) - for the purpose of prevention;
- candidiasis of the mucous membranes and esophagus, oropharyngeal candidiasis in children (for solution).
Contraindications
Absolute:
- Simultaneous administration of Fluconazole at doses ≥ 400 mg / day with drugs that prolong the QT interval (terfenadine, astemizole, etc.);
- lactation (breastfeeding period);
- children under 3 years of age (for tablets and capsules);
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for tablets and capsules, which have milk sugar as one of the auxiliary components);
- hypersensitivity to the components of the drug and other antifungal agents derived from azole.
Relative (Fluconazole is used with caution due to the increased risk of complications): liver failure, rash that occurs during therapy in patients with invasive / systemic and superficial fungal infections, potentially proarrhythmogenic conditions in patients with multiple risk factors (electrolyte imbalance, organic heart damage, simultaneous use with acetylsalicylic acid, drugs that cause arrhythmias, rifabutin and other inducers of cytochrome P 450), pregnancy, use in doses <400 mg / day simultaneously with terfenadine, astemizole, etc.
The use of fluconazole during pregnancy should be avoided, except in cases of treatment of severe fungal infections that potentially threaten a woman's life, when the predicted benefit to her significantly outweighs the likely risk to the developing fetus.
Method of administration and dosage
The choice of the dosage form of the drug, the optimal dose and the duration of the course of therapy is individual and depends on the indications, the patient's condition, clinical and mycological responses to the antifungal agent.
The daily dose is determined depending on the nature of the infection and the severity of the disease.
In case of switching from intravenous administration (solution for infusion) to oral administration of the drug (capsules, tablets), there is no need to change the daily dose of fluconazole.
Capsules and tablets are taken orally, regardless of food intake, swallowing whole and drinking a glass of water.
The solution for infusion is administered intravenously (intravenously) by drop, at a rate of no more than 200 mg / hour. It is recommended that infusions be performed using conventional transfusion sets using any of the following solvents: 20% dextrose solution, Ringer's solution, Hartman's solution, 5% dextrose solution and 0.9% potassium chloride solution, 4.2% sodium bicarbonate solution, 0.9 % sodium chloride solution.
Recommended dosing regimen for adult patients:
- cryptococcal infections, disseminated candidiasis, candidemia, and other invasive candidiasis infections: on the first day - 400 mg, then 200–400 mg once a day; the duration of the course depends on the clinical and mycological response (for example, cryptococcal meningitis - at least 6-8 weeks);
- cryptococcal meningitis in AIDS patients (for prophylaxis): at the end of the full course of primary therapy with Fluconazole at a dose of 200 mg per day, treatment can be carried out for a long time;
- oropharyngeal candidiasis: within 7-10 days, 50-100 mg 1 time per day, the duration of the course with immunosuppression - 14 days or more; in order to prevent relapses in AIDS patients, at the end of the full course of primary therapy, a maintenance dose of 150 mg weekly is recommended;
- atrophic oral candidiasis associated with wearing dentures: for 14 days, 50 mg once a day as part of a complex treatment with local antiseptics for processing the denture;
- candidiasis of the mucous membranes (with the exception of genital): within 14-30 days, 50-100 mg 1 time per day;
- vaginal candidiasis: 150 mg once; in order to reduce the frequency of relapses, for prophylaxis, for 4-12 months, 150 mg 1 time per month, sometimes more frequent use may be necessary;
- balanitis caused by Candida: 150 mg once;
- candidiasis (for prevention): depending on the likelihood of developing a fungal infection - from 50 to 400 mg per day; high risk of generalized infection (for example, in patients with long-term or severe neutropenia after irradiation or chemotherapy with cytostatics), the recommended dose is 400 mg / day; Fluconazole begins to be used several days before the predicted appearance of neutropenia, with an increase in the number of neutrophils ≥ 1 thousand / μL, therapy is continued for another 7 days;
- skin lesions, including mycoses of the groin area and feet, candidiasis: within 14-28 days, 150 mg once a week or 50 mg once a day; treatment of mycoses of the feet may require a longer period, up to 6 weeks;
- pityriasis versicolor: within 14 days, 300 mg once a week (depending on the patient's response to fluconazole, a third dose of 300 mg once a week may be required, or a single dose of 300-400 mg may be sufficient); an alternative scheme: within 2-4 weeks, 50 mg once a day;
- onychomycosis: 150 mg once a week before replacing the infected nail; normally it takes 3–6 months for the fingers, 6–12 months for the toes; growth rate can depend on age and vary widely from person to person; after successful treatment of long-standing chronic infections, the shape of the nails may change;
- deep endemic mycoses: with therapy for up to 2 years, 200-400 mg per day (coccidioidomycosis - 11-24 months, paracoccidioidomycosis - 2-17 months, sporotrichosis - 1-16 months, histoplasmosis - 3-17 months).
The duration of therapy in children, as with similar infections in adults, depends on the clinical and mycological responses. Children's daily dose should not exceed that in adults (for similar indications). Fluconazole is used once a day, daily, using a suitable dosage form. The maximum daily dose for children is 400 mg.
Recommended dosing regimen for children over 3 years old:
- esophageal candidiasis: 3 mg / kg / day for at least 21 days and another 14 days after symptom regression;
- candidiasis of the mucous membranes: 3 mg / kg / day for at least 21 days;
- generalized candidiasis and cryptococcal infection (including meningitis): 6-12 mg / kg / day for 70-84 days, until laboratory-confirmed absence of pathogens in the cerebrospinal fluid;
- fungal infections in children with reduced immunity, in whom the risk of developing an infection is associated with neutropenia, which develops as a result of radiation or chemotherapy with cytostatics (for prophylaxis): 3–12 mg / kg / day, depending on the duration of preservation and the severity of induced neutropenia.
For children with impaired renal function, the daily dose of the drug is reduced according to the severity of renal failure in the same proportional relationship as in adults.
When using the drug in the form of a solution in newborns (up to 4 weeks), it is required to take into account that the elimination of fluconazole is slow. In children, the first 2 weeks of life, the drug is used in the same dose (mg / kg) as at an older age, but with an interval of 72 hours; at the age of 3-4 weeks the same dose is administered at intervals of 48 hours.
Elderly patients in the absence of signs of renal failure do not require dose adjustment.
In case of impaired renal function, adult patients are initially given a loading dose of 50 to 400 mg, the subsequent daily doses are determined depending on the CC (creatinine clearance) according to the following scheme:
- CC> 50 ml / min - 100% of the recommended dose.
- CC 11-50 ml / min (without dialysis) - 50% every 24 hours or 100% every 48 hours.
- Dialysis patients - 100% after each dialysis session.
Side effects
The most common side effects observed during clinical trials of fluconazole were headache, skin rash, abdominal pain, nausea, diarrhea.
Other adverse reactions from organs and systems:
- nervous system: often - headache; infrequently - paresthesia, convulsions, dizziness, seizures, tremors, drowsiness, insomnia, general weakness, severe fatigue;
- cardiovascular system: rarely - prolongation of the QT interval, arrhythmia of the pirouette type;
- digestive system: often - decreased appetite, abdominal pain, nausea, vomiting, diarrhea; infrequently - flatulence, constipation, anorexia, dyspepsia, dryness of the oral mucosa, toothache, change in taste;
- hepatobiliary system: often - a clinically significant increase in the activity of liver enzymes [ALT (alanine aminotransferase), AST (aspartate aminotransferase), alkaline phosphatase (alkaline phosphatase)]; infrequently - hepatitis, jaundice, cholestasis, scleral icterus, clinically significant increase in the concentration of total bilirubin in the blood plasma (0.3%); rarely - liver dysfunction, toxic hepatitis (including fatal);
- hematopoietic organs: infrequently - anemia; rarely - thrombocytopenia (petechial hemorrhages, bleeding), leukopenia, agranulocytosis, neutropenia;
- skin: infrequently - hyperhidrosis, drug-induced dermatitis; very rarely - acute generalized exanthematous pustulosis;
- musculoskeletal system: infrequently - myalgia;
- organ of hearing and balance: infrequently - vertigo;
- metabolism: rarely - hypertriglyceridemia, hypokalemia, hypercholesterolemia;
- hypersensitivity reactions: often - skin rash; rarely - exudative erythema multiforme (including Stevens-Johnson syndrome), anaphylaxis; very rarely - exfoliative dermatitis, Lyell's syndrome (toxic epidermal necrolysis), anaphylactoid reactions (including facial edema, angioedema, itching, urticaria);
- other: rarely - alopecia, renal failure.
Side effects are more common in children than in adults, with anemia and irritability being the most common.
Fluconazole overdose symptoms: paranoid behavior, hallucinations.
Treatment of this condition is symptomatic: formed diuresis, gastric lavage. Hemodialysis conducted for three hours, reduces the plasma concentration of the substance approximately 1 / 2.
special instructions
Drug therapy is continued until clinical and hematological remission appears, since prematurely discontinued treatment leads to relapses.
It is possible to start using fluconazole in the absence of culture data / other laboratory tests, but if available, fungicidal therapy should be adjusted accordingly.
It is necessary to monitor blood counts, kidney and liver function during therapy. In case of hepatic / renal impairment, the drug should be discontinued.
The hepatotoxic effect of fluconazole is usually reversible; after discontinuation of therapy, its symptoms disappear.
The simultaneous use of the drug with coumarin anticoagulants requires control of the prothrombin index.
Patients engaged in potentially hazardous work should be aware of the potential for side effects such as seizures and dizziness. It is recommended to be careful when driving and working with complex machines and mechanisms.
Drug interactions
- warfarin: prothrombin time increases on average by 12% (careful monitoring of prothrombin time in patients receiving fluconazole in combination with coumarin anticoagulants is recommended);
- oral hypoglycemic agents, sulfonylurea derivatives (glibenclamide, chlorpropamide, glipizide, tolbutamide): in healthy people, fluconazole increases their half-life from plasma; in patients with diabetes, due to this combination, hypoglycemia may develop;
- phenytoin: it is possible to increase the plasma concentration of phenytoin to a clinically significant level (monitoring of the concentration of phenytoin and adjustment of its dose is required to maintain the level of the drug within the therapeutic range);
- rifampicin: reduced by 25% AUC and reduced by 20% the half-life of fluconazole from plasma (it is advisable to increase the dose of fluconazole);
- cyclosporine: the plasma concentration of cyclosporine slowly increases in patients with a transplanted kidney when using fluconazole at a dose of 200 mg / day (control of this indicator is necessary);
- theophylline (in high doses or with the likelihood of developing theophylline intoxication): fluconazole reduces the average rate of theophylline clearance from plasma (monitoring of patients is required to detect early signs of theophylline overdose in an early stage);
- terfenadine, cisapride: there is evidence of cases of undesirable effects from the cardiovascular system [tachycardia, dizziness, increased risk of arrhythmias, including paroxysms of ventricular tachycardia (torsades de pointes)];
- hydrochlorothiazide: an increase of up to 40% of the plasma concentration of fluconazole is possible;
- rifabutin: its serum level rises, as a result of which uveitis may develop (control of the joint use of these drugs is required);
- zidovudine: the conversion of zidovudine into its main metabolite decreases, which leads to an increase in its concentration; an increase in undesirable side effects characteristic of zidovudine is possible;
- midazolam: fluconazole increases its concentration, increasing the risk of developing psychomotor effects (more pronounced with the use of oral forms of fluconazole);
- tacrolimus: increased risk of nephrotoxicity.
Terms and conditions of storage
Store in a place protected from moisture and light, out of reach of children. Tablets and capsules at a temperature not exceeding 25-30 ° C. Solution for infusion - 2 to 30 ° C. Do not freeze!
Shelf life: solution - 2 years, tablets - 3 years, capsules - 3-5 years (depending on the manufacturer).
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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
