Dosage and administration
Inside Capsules are swallowed whole.
Therapy can be started before the results of seeding and other laboratory tests. However, antifungal therapy needs to be changed accordingly, when the results of these studies become known.
When transferring a patient from intravenous to oral administration of the drug or vice versa, a change in the daily dose is not required.
The daily dose of the drug Diflucan depends on the nature and severity of the fungal infection. In case of infections requiring repeated administration of the drug, treatment should be continued until the clinical or laboratory signs of an active fungal infection disappear. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually need supportive therapy to prevent recurrence of infection.
Use in adults
1. For cryptococcal meningitis and cryptococcal infections of another location, 400 mg is usually used on the first day, and then continue the treatment at a dose of 200-400 mg once a day. The duration of treatment of cryptococcal infections depends on the presence of clinical and mycological effect; with cryptococcal meningitis, treatment is usually continued for at least 6-8 weeks. In cases of treating life-threatening infections, the daily dose can be increased to 800 mg.
To prevent relapse of cryptococcal meningitis in patients with a high risk of relapse, after completing the full course of primary treatment, therapy with Diflucan at a dose of 200 mg/day can be continued for an indefinite period of time.
2. When coccidioidomycosis may require the use of the drug in a dose of 200-400 mg/day. For some infections, especially those with damage to the meninges, a dose of 800 mg per day may be considered. The duration of therapy is determined individually, it can last up to 2 years; it is 11-24 months for coccidioidomycosis, 2-17 months for paracoccidioidomycosis, 1-16 months for sporotrichosis and 3-17 months for histoplasmosis.
3. For candidemia, disseminated candidiasis and other invasive candidal infections, the saturating dose is 800 mg on the first day, the subsequent dose is 400 mg/day. The duration of therapy depends on the clinical effectiveness. The general recommendation on the duration of treatment of candidemia is 2 weeks after the first negative result of blood culture and the disappearance of signs and symptoms of candidaemia.
Treatment of mucous candidiasis
- With oropharyngeal candidiasis, the saturating dose is 200-400 mg on the first day, the following dose: 100-200 mg once a day for 7-21 days. If necessary, patients with pronounced suppression of immune function can continue treatment for a longer time. In case of atrophic oral candidiasis associated with the wearing of dentures, the drug is usually used at a dose of 50 mg once a day for 14 days in combination with local antiseptic agents for the treatment of the prosthesis.
- For candiduria, the effective dose is usually 200-400 mg/day with a duration of treatment of 7-21 days. In patients with severely impaired immune system function, longer periods of therapy can be used.
- In chronic mucous candidiasis, 50–100 mg per day for up to 28 days of treatment is used. Depending on the severity of the treatment of the infection or the concomitant impairment of the immune system and the infection, longer periods of therapy can be used.
- For candidiasis of the esophagus, the saturating dose of 200-400 mg on the first day, the subsequent dose: 100-200 mg per day. The course of treatment is 14-30 days (until remission of esophageal candidiasis is achieved). If necessary, patients with pronounced suppression of immune function can continue treatment for a longer time.
- To prevent recurrence of oropharyngeal candidiasis in HIV-infected patients with a high risk of recurrence, the drug is used on 100-200 mg per day or 200 mg 3 times a week for an indefinite period of time in patients with chronically reduced immunity.
- To prevent the recurrence of esophageal candidiasis in HIV-infociated patients with a high risk of recurrence, the drug is used on 100-200 mg per day or 200 mg 3 times per week for an indefinite period of time in patients with chronically reduced immunity.
- In case of chronic atrophic candidiasis of the oral cavity associated with denture intercourse, the drug is usually used at a dose of 50 mg once a day for 14 days in combination with local antiseptic agents for the treatment of the prosthesis.
- In acute vaginal candidiasis, candidal balanitis, the drug is used once inside in a dose of 150 mg. To reduce the frequency of recurrences of vaginal candidiasis, the drug can be used in a dose of 150 mg every three days - only 3 doses (on the 1st, 4th and 7th day), then a maintenance dose of 150 mg once a week. Maintenance dose can be applied up to 6 months.
Treatment of ringworm
- For skin infections, including foot dermatophytosis, trunk dermatophytosis, inguinal dermatophytosis and candidal infections, the recommended dose is 150 mg once a week or 50 mg once a day. The duration of therapy is usually 2-4 weeks, with mycoses of the feet, longer therapy up to 6 weeks may be required.
- With lichen colored pills, the recommended dose is 300-400 mg once a week for 1-3 weeks. An alternative treatment regimen is the use of the drug in 50 mg once a day for 2-4 weeks.
4. For onychomycosis, the recommended dose is 150 mg once a week. Treatment should be continued until the infected nail is replaced (the uninfected nail grows). To re-grow nails on the fingers and feet, it usually takes 3-6 months and 6-12 months, respectively. However, the growth rate can vary widely among different people, as well as depending on age. After successful treatment of long-lasting chronic infections, a change in the shape of the nails is sometimes observed.
5. For the prevention of candidiasis in patients with malignant tumors, the recommended dose of the drug Diflucan is 200-400 mg once a day, depending on the degree of risk of developing a fungal infection. For patients with a high risk of generalized infection, for example, with severe or prolonged neutropenia, the recommended dose is 400 mg once a day. Diflucan is used several days before the expected development of neutropenia and, after an increase in the number of neutrophils more than 1000 per mm3, the treatment is continued for another 7 days.
Use in children
As with similar infections in adults, the duration of treatment depends on the clinical and mycological effect. For children, the daily dose of the drug should not exceed that for adults. Diflucan is used daily once a day.
In case of candidiasis of the mucous membranes, the recommended dose of the drug Diflucan is 3 mg/kg/day. On the first day, in order to reach the equilibrium concentration more quickly, a loading dose of 6 mg / kg can be applied.
For the treatment of invasive candidiasis and cryptococcal meningitis, the recommended dose is 6-12 mg/kg/day, depending on the severity of the disease.
To suppress the recurrence of cryptococcal meningitis in children with AIDS, the recommended dose of the drug Diflucan is 6 mg/kg/day.
For the prevention of fungal infections in children with depressed immunity, in whom the risk of developing an infection is associated with neutropenia, developing as a result of cytotoxic chemotherapy or radiation therapy, the drug is used at 3-12 mg/kg/day, depending on the severity and duration of preservation of induced neutropenia (see Dose for adults; for children with renal insufficiency - see dose for patients with renal insufficiency).
If it is impossible for the dosage form of the drug Diflucan in the form of capsules to be properly used in children, the possibility of replacing it with other dosage forms of the preparation (powder for oral suspension or solution for intravenous administration) in equivalent doses should be considered.
Use in the elderly
In the absence of signs of renal failure, Diflucan is used in the usual dose. In patients with renal insufficiency (creatinine clearance <50 ml/min), the dose of the drug is adjusted as described below.
Use in patients with renal failure
With a single dose dose is not required. In patients (including children) with impaired renal function with repeated use of the drug, the loading dose should initially be administered from 50 mg to 400 mg, after which the daily dose, depending on the indication.
Regular dialysis patients should receive 100% of the recommended dose after each dialysis session. On the day when dialysis is not performed, patients should receive a reduced (depending on creatinine clearance) dose of the drug.
In children with impaired renal function, the daily dose of the drug should be reduced in the same proportional dependence as in adults), in accordance with the severity of renal failure.
Criteria for assessing the frequency: very frequent 10%; frequent 1% and <10%; infrequent 0.1% and <1%; rare> 0.01% and <0.1%; very rare <0.01%, frequency unknown - impossible to determine based on available data.
Tolerability is usually very good.
The following adverse reactions were noted in clinical and post-marketing studies of the drug Diflucan:
On the part of the nervous system: frequent - headache; infrequent - dizziness, convulsions, change in taste, paresthesia, insomnia, drowsiness; rare - tremor.
On the part of the digestive system: frequent - abdominal pain, diarrhea, nausea, vomiting; infrequent - flatulence, dyspepsia, dry oral mucosa, constipation.
On the part of the hepatobiliary system: frequent - an increase in serum activity of aminotransferases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST), alkaline phosphatase; infrequent - cholestasis, jaundice, increased concentration of bilirubin; rare - hepatotoxicity, in some cases with a fatal outcome, abnormal liver function, hepatitis, hepatocellular necrosis, hepatocellular damage.
On the part of the skin: frequent - rash; infrequent - pruritus, urticaria, sweating, drug rash; rare - exfoliative skin lesions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exantmatous pustus, facial edema, alopecia.
On the part of the blood-forming organs and the lymphatic system: rare - leukopenia, including neutropenia and agranulocytosis, thrombocytopenia, anemia.
Immune system: anaphylaxis (including angioedema).
Since the cardiovascular system: rare - an increase in the QT interval on the ECG, ventricular tachysystolic arrhythmia type "pirouette."
On the part of metabolism: rare - an increase in the concentration of cholesterol and triglycerides in the blood plasma, hypokalemia.
From the musculoskeletal system: infrequent - myalgia.
Other: infrequent - weakness, asthenia, fatigue, fever, vertigo.
In some patients, especially those suffering from serious diseases such as AIDS or cancer, changes in blood parameters, kidney and liver function were observed during treatment with Diflucan and similar drugs, but the clinical significance of these changes and their relationship to treatment have not been established.
There are reports of an overdose of fluconazole, and in one case, a 42-year-old patient infected with the human immunodeficiency virus, after taking 8200 mg of the drug, had hallucinations and paranoid behavior. The patient was hospitalized; his condition returned to normal within 48 hours.
In case of overdose, symptomatic treatment (including supportive measures and gastric lavage) can give an adequate effect.
Fluconazole is eliminated mainly through the kidneys, so forced diuresis can probably accelerate the excretion of the drug. A hemodialysis session lasting 3 hours reduces plasma plasma levels of fluconazole by approximately 50%.