Flucozu (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 injections are the same. Administer this medicine by intravenous injection at a rate of approximately 5 - 10 mL/min. 1) Oropharyngeal candidiasis The usual dose is 50 mg 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 once daily for 14 days. Local disinfection of dentures should also be performed. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, and mucocutaneous candidiasis, 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. 4) 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 400 mg once daily according to the patient's response. The duration of treatment is determined according to clinical response and medical judgment. 5) 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 is usually continued for at least 6 - 8 weeks. 6) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed the initial treatment. 7) 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 infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. 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 more. The usual adult dose may be administered only when renal function is normal. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. This medicine is excreted mainly unchanged in the urine. No dose adjustment is necessary for a single dose. For multiple doses, administer the usual dose only on the first day, then adjust the dose as follows from the next day. Creatinine clearance (mL/min) | Recommended dose >50 | 100% of the usual dose ≤50 (not on dialysis) | 50% of the usual dose Patients on hemodialysis | 100% of the usual dose after each hemodialysis session For patients on hemodialysis, administer 100% of the usual dose after each hemodialysis session; on nondialysis days, administer a reduced dose according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined as follows and must 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). 1) Oropharyngeal candidiasis Administer 6 mg/kg on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 2) Esophageal candidiasis Administer 6 mg/kg 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 according to the patient's response. Continue treatment 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, and urinary tract infections, 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 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 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 the 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 of less than 10 mg, use oral syrup or intravenous injection, depending on the child's clinical condition, to ensure accurate dosing.

This drug should not be used in patients with known allergic reactions or in pregnant or nursing women. Caution is advised for patients with heart disease or electrolyte imbalance, as well as those with compromised kidney or liver function. This drug may interact with several other medications, so if you are taking other medications, be sure to consult a physician or pharmacist. Pregnant women should avoid this drug, especially in early pregnancy, as it may affect the fetus, so contraception is recommended. Nursing women should also avoid this medication, as it may be excreted in breast milk. Safety has not been established in pediatric patients, particularly infants under 6 months of age, and this drug should only be used with caution where absolutely necessary. During treatment, dizziness or seizures may occur, so be careful when driving or operating machinery. In cases of overdose, hallucinations or behavioral changes may occur, so contact a medical institution immediately for appropriate treatment. This drug is mainly excreted in urine; thus, in cases of overdose, drug concentration can be reduced through dialysis. It may be mixed with certain intravenous solutions, but mixing with other medications or fluids is not recommended.

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, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular injury, 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 (DRESS), myalgia, fatigue, malaise, asthenia, fever, hallucinations, paranoid behavior

Store this medication in a sealed container to protect it from air and moisture. The ideal storage temperature is between 1 and 30 degrees Celsius.

Appearance

A colorless and transparent liquid contained in a colorless and transparent vial.

Package unit

In-house packaging unit