Funazole M Capsule (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. ○ Adults 1. Vulvovaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral pain caused by dentures): The usual dose is 50 mg of this drug 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 vulvovaginal candidiasis): The usual dose is 50 mg of this drug 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, urinary tract, etc.): The usual dose is 400 mg of this drug 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 the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment should be determined by the clinical and mycological response, but treatment should usually be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. 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 drug 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 undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the onset of neutropenia is expected, and continue administering 400 mg 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 nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; the rate of growth may vary between individuals and with age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. 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 drug once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks, depending on its course. 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 should be extended. ○ Patients with renal impairment This drug 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 of treatment 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, the dose should be reduced according to creatinine clearance.

Children's dosage

Pediatric doses based on the adult dose are generally determined according to the following guidelines 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 The safety and efficacy have not been established in infants younger than 6 months. 1. Oropharyngeal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. The dose may be increased to 12 mg/kg of body weight 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 of body weight once daily. The duration of treatment should be determined based on clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of body weight of this medicine on the first day, followed by 6 mg/kg of body weight once daily from the next day. The dose may be increased to 12 mg/kg of body weight 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 of body weight once daily after the patient has completed the full course of initial treatment. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to specific patients. For example, patients with allergies to this medication or similar drugs, women who are pregnant or may become pregnant, and nursing mothers should not take this medication. Additionally, patients taking certain medications should avoid concurrent use of this medication as it may cause serious side effects. This medication contains lactose, so it should not be used in patients with lactose intolerance or related genetic diseases. Patients with kidney or liver function impairments, or heart disease or at risk of arrhythmia, should use this medication with caution. In such cases, close monitoring and examination by a physician is necessary. This medication may interact with several others, so patients taking other medications should inform their healthcare provider, and dose adjustments or monitoring may be required. Blood tests, liver function tests, and kidney function tests should be performed before using this medication. While this medication is generally well tolerated, rare instances of abnormal reactions related to blood, liver, or kidney may occur, so patients should immediately consult healthcare professionals if they experience any unusual symptoms. Pregnant women should avoid using this medication as it may harm the fetus, and women of childbearing age should ensure effective contraception during and for some time after taking this medication. Nursing mothers should also avoid this medication as it can be secreted in breast milk and may affect the baby. Safety in children, especially infants under 6 months, has not been established, so it should be used cautiously only in special cases. Care should be taken when driving or operating machinery as this medication may cause dizziness or seizures. In cases of overdose, hallucinations or abnormal behaviors may occur, and appropriate treatment should be received from medical institutions immediately. This medication is primarily excreted through urine, so hemodialysis may be helpful in cases of overdose.

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

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle