Fluconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg once daily for 14 days; local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg 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, urinary tract, etc.): The usual dose is 400 mg as a single dose on the first day, followed by 200 mg once daily starting the next day; the dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg as a single dose on the first day, followed by 200-400 mg once daily starting 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. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed primary treatment, administer 200 mg once daily indefinitely. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg once daily according to the patient's risk of 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 expected prolonged neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the nails have regrown (until uninfected new nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary by individual and 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 once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks 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, use the usual adult dose. If renal impairment is present (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: No dose adjustment is needed for a single dose. If multiple doses are required, administer the usual dose only on the first day, then adjust the dose as follows from the next day. Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, reduce the dose 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. Infants younger than 6 months: Safety and efficacy have not been established. Oropharyngeal candidiasis: 6 mg/kg on the first day, then 3 mg/kg once daily starting the next day; administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg on the first day, then 3 mg/kg once daily starting the next day; depending on the patient's response, increase to 12 mg/kg once daily; 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, urinary tract, etc.): 6-12 mg/kg once daily; the duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: 12 mg/kg on the first day, then 6 mg/kg once daily starting the next day; depending on the patient's response, increase to 12 mg/kg once daily; administer for 10-12 weeks after a negative cerebrospinal fluid culture is obtained. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed primary treatment, administer 6 mg/kg once daily. Children with renal impairment: Extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, use oral syrup or intravenous injection according to the child's clinical condition to ensure accurate dosing.

This medication may not be suitable for certain patients. For example, individuals allergic to this medication or other similar medications, pregnant women, or breastfeeding women should not take it. Additionally, caution is required for patients taking certain other medications alongside this drug, particularly those that may affect the heart, or patients with liver or kidney function issues. This medication may exacerbate liver function, so patients with liver disease should use it under careful medical supervision. Patients with reduced kidney function may need kidney function tests before administration and dose adjustments. Patients with heart disease or electrolyte imbalance should exercise caution with this medication, as it may affect heart rhythm. There is a risk of QT interval prolongation, which may necessitate cardiac monitoring. This medication can interact with various other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Some drug interactions can increase the risk of side effects or alter efficacy, necessitating caution. Pregnant women should avoid this medication as it may harm the fetus, and women of childbearing potential must practice effective contraception during and for a certain period after treatment. Breastfeeding women should also consult a doctor as this drug may be passed through breast milk, leading to a decision to either avoid breastfeeding or consult a physician. This medication has not been adequately tested for safety and efficacy in children, particularly in infants under 6 months of age, and should only be used when absolutely necessary. During use, patients may experience dizziness or seizures, so caution is advised when driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, and immediate medical attention must be sought. Gastric lavage or supportive therapy may be required, and hemodialysis may lower the body concentration of this drug.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, 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, liver failure, hepatic necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, exfoliative dermatitis, facial swelling, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, bizarre behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to safely maintain the drug's efficacy.

Appearance

A capsule filled with white powder; the upper part is blue and the lower part is white.

Package unit

30 capsules/bottle, 100 capsules/bottle