Fluconazole Capsule 50 mg (Fluconazole)

Adult dosage

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

Children's dosage

Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. 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 However, safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to up to 12 mg/kg body weight once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, and urinary tract infections, etc.): Administer 6-12 mg/kg body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed all primary treatment. In pediatric patients with renal impairment, the dosing interval should be increased and the dose reduced according to the same criteria used for adults with renal impairment. When administering doses of less than 10 mg, administer the syrup orally or inject the solution intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, those allergic to this medication or similar drugs, pregnant or nursing women, and patients taking specific medications should not take this drug. Patients with kidney or liver issues, heart disease, or those at risk for arrhythmias should use this medication cautiously. Patients with a history of drug hypersensitivity also need to exercise caution. This drug may affect liver and kidney functions, so it is essential to conduct blood tests and liver and kidney function checks regularly during treatment. Special caution is warranted in patients with severe illnesses due to the potential for liver damage. This medication can interact with multiple drugs; thus, if you are taking other medications, it is crucial to inform your doctor or pharmacist, as dose adjustments or monitoring may be necessary. Women who are pregnant or could become pregnant should ensure effective contraceptive measures during and for some time after taking this medication, and should particularly avoid it in early pregnancy. Nursing mothers should refrain from taking this drug as it is secreted in breast milk. For infants under 6 months of age, safety has not been established, so use should be cautious and only if necessary. When taking this medication, dizziness or seizures may occur, so care is required when driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, so immediate medical attention should be sought, and treatment such as dialysis may be necessary if required.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized eruptive pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, altered behavior

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best stored at room temperature, between 1-30 degrees Celsius.

Appearance

A hard capsule with a light blue upper part and a white lower part filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle