J-Flu Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are absorbed rapidly and almost completely, 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 of this drug is 50mg 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 of this drug is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this drug is 50 mg once daily for 14-30 days; for refractory mucosal candidiasis, the dose may be increased to 100mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400mg once on the first day, followed by 200mg once daily from the next day; the dose may be increased to 400mg daily depending on the patient's response. 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 of this drug is 400mg once on the first day, followed by 200 ~ 400mg once daily from the next day. The duration of treatment is determined by clinical and mycological response, but treatment should usually be given for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer at least 100mg 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 resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50~ 400mg of this drug daily, depending on the patient's risk of developing a fungal infection. A dose of 400mg daily is recommended for patients at very high risk of systemic fungal infections, such as those undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In these patients, 400mg should be administered starting 5-6 days before the anticipated onset of neutropenia and 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). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; growth rates may vary between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug is 50 mg 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 infection. For tinea versicolor, administer 50mg once daily for 2-4 weeks. Elderly patients If renal function is normal, the usual adult dose is administered. In the presence of renal impairment (creatinine clearance 40 ml/min or less), the dose should be reduced or the dosing interval extended. Patients with renal impairment This drug is excreted mainly in the urine in unchanged form. No dose adjustment is necessary for 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) — Recommended dose > 50 — 100 % of the usual dose < 50 (not on dialysis) — 50% of the usual dose Patients on regular dialysis — 100% of the usual dose after each dialysis session Patients receiving regular dialysis should receive 100% of the usual dose after each dialysis session; on nondialysis days, the dose should be reduced according to creatinine clearance.

Children's dosage

Children 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 However, the safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis – Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis – Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg daily from the next day. The dose may be increased to 12mg daily according to 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 6-12mg/kg daily. The duration of administration should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis – Administer 12 mg/kg of this medicine on the first day, followed by 6 mg/kg daily from the next day. The dose may be increased to 12 mg/kg daily according to 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 initial treatment. 6. In children with renal impairment, extend the dosing interval and reduce the dose according to the degree of renal impairment, using the same criteria as for adults with renal impairment. When administering doses less than 10mg, administer the oral syrup according to the child's clinical condition to ensure accurate dosing, or administer the injection intravenously.

This medication should not be administered to certain patients. For example, it should not be used in individuals with an allergy to this drug or similar compounds, as well as in pregnant or nursing women. Additionally, concomitant use with certain medications may lead to severe side effects; therefore, it should be avoided. Patients with impaired kidney or liver function, heart disease, or those at risk of arrhythmia should use this drug with extreme caution. This drug may affect liver function, so liver function tests may be required. Some patients may experience side effects such as headache, dyspepsia, skin rash, and liver function abnormalities. If such symptoms are severe or persistent, consult a healthcare provider immediately. This drug has numerous interactions with other medications, and dose adjustments or monitoring may be necessary depending on the drugs taken together. Caution should be exercised when used in combination with drugs that affect the heart, anticoagulants, antidepressants, immunosuppressants, etc. Women who are pregnant or could become pregnant should consult a physician before taking this drug, and effective contraception should be practiced during treatment. Nursing mothers are advised not to take this medication. Safety has not been established for children, particularly infants under 6 months of age, so it should only be used cautiously when necessary. Dizziness or seizures may occur while taking this medication, so caution should be exercised when driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, requiring immediate medical attention. This drug is primarily excreted in urine, thus adequate fluid intake may be beneficial.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocyte damage, rash, itching, 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, hallucinations, and behavioral disturbances.

Store this medication in a tightly sealed container to protect it from air and moisture. It is advisable to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its efficacy and ensure safe usage.

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