Trifucan Forte Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this product once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg of this product once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this product once daily for 14-30 days; for refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, genitourinary, etc.): The usual dose is 400 mg of this product once on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this product once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment is determined by clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this product once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this product once daily, depending on the patient's degree of risk of developing a fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. In such patients, 400 mg should be administered starting 5-6 days before the onset of neutropenia is expected, and 400 mg should be continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the rate of growth may vary between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this product once daily or 150 mg once weekly for 2-4 weeks. However, for athlete's foot, treatment for 6 weeks may be required depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should be administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This product is excreted mainly unchanged in the urine. No dose adjustment is necessary for a single dose; however, when multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the next day as follows: Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not receiving dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

Adult dose 100 mg: pediatric dose 3 mg/kg Adult dose 200 mg: pediatric dose 6 mg/kg Adult dose 400 mg: pediatric dose 12 mg/kg Do not exceed 400 mg. Safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of this drug on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all primary treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, administer the syrup orally or the injection intravenously according to the child's clinical condition to ensure an accurate dose.

This medication should not be administered to certain patients. First, patients who have had allergic reactions to this drug or similar medications should avoid taking it. Additionally, this drug should not be used in women who are pregnant or may become pregnant, nor in breastfeeding women. Serious side effects may occur when taken with specific medications, so patients taking prohibited concomitant medications should not use this drug. Since this drug contains lactose, it should not be administered to patients with lactose intolerance or related genetic disorders. Patients with kidney or liver function problems, heart disease, or electrolyte imbalances should use this medication with caution. Patients with a history of drug hypersensitivity reactions should also be careful. Moreover, this drug can significantly inhibit certain enzymes and may interact with other medications, so it is essential to inform a doctor or pharmacist about any concomitant medications and to be monitored. While this medication generally has good tolerability, rare adverse reactions may occur affecting blood, liver, kidneys, skin, and the nervous system. There is a possibility of serious side effects, such as liver function abnormalities or cardiac arrhythmias, so if symptoms arise, immediate consultation with medical personnel is necessary. This medication should be avoided during pregnancy as it may harm the fetus, and women of childbearing age should use effective contraception during and for a certain period after treatment. It is also recommended that lactating women avoid taking this drug. Safety in children, especially infants younger than 6 months, has not been established, so it should only be administered cautiously if necessary. While taking this medication, patients should be cautious when driving or operating machinery as dizziness or seizures may occur. In case of overdose, hallucinations or unusual behaviors may present, necessitating an immediate visit to a medical facility for appropriate treatment. This drug is mainly excreted in urine, and blood dialysis can be used to lower its concentration in the body if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocyte damage, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is also recommended to keep it at room temperature between 1°C and 30°C, avoiding excessively hot or cold conditions.

Appearance

Capsule with an upper light blue and lower white color filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle