OneFlu Injection (Fluconazole)

Adult dosage

The route of administration should be determined based on the patient's clinical condition. Because the oral formulation is rapidly and almost completely absorbed, the doses of oral formulations (capsules, dry syrup) and injections are the same. Administer this drug by intravenous injection at a rate of approximately 5 - 10 mL/min. 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 caused by dentures): The usual dose is 50 mg once daily for 14 days. Dentures should also be disinfected locally. Other mucosal candidiasis (esophageal candidiasis, excluding vaginal candidiasis; noninvasive bronchopulmonary infections; candiduria; mucocutaneous candidiasis, etc.): 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, and urinary tract infections, etc.): The usual dose is 400 mg as a single dose on the first day, followed by 200 mg once daily from the next day. The dose may be increased to 400 mg once daily depending on 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 as a single dose 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 generally given for at least 6 - 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed initial treatment. 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, depending on 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 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 expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or above. 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 drug is excreted mainly unchanged in the urine. No dose adjustment is necessary when administering 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) >50: 100% of the usual dose Creatinine clearance (mL/min) ≤50 (not on dialysis): 50% of the usual dose Hemodialysis patients: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session; on nondialysis days, administer a reduced 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 a maximum of 400 mg. The safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 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. 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 depending on 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 once daily. The duration of treatment is determined according to clinical response and medical judgment. 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 depending on the patient's response. Treatment should continue for 10 - 12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed initial treatment. Children with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. For example, patients with allergies to this medication or similar medications, pregnant women or women who may become pregnant, and nursing women should not use this medication. In addition, serious side effects may occur when taking this medication in conjunction with certain drugs, so patients taking terfenadine, cisapride, astemizole, erythromycin, quinidine, pimozide, or ergotamine should not use this medication. Patients with renal or liver dysfunction, heart disease, or electrolyte disturbances that could lead to arrhythmia should use this medication with caution. Such patients may experience side effects such as worsening liver function or cardiac rhythm disturbances. This medication is generally well tolerated, but in rare cases, abnormalities in blood or liver function may occur, and side effects such as headache, dizziness, dyspepsia, and rash may also be observed. In severe cases, there is a rare possibility of life-threatening liver toxicity or cardiac arrhythmia, so caution is required. While taking this medication, regular blood tests, liver function tests, renal function tests, and electrolyte tests should be performed, and especially if there is a significant increase in liver enzyme levels, the administration of this drug should be re-evaluated. Additionally, this medication can interact with several other drugs, so if you are currently taking other medications, you must inform your physician or pharmacist. In particular, dosage adjustment or monitoring may be necessary when used concurrently with anticoagulants, antidepressants, antibiotics, anticonvulsants, immunosuppressants, or calcium channel blockers. It is generally recommended not to use this medication during pregnancy, and women of childbearing age should ensure effective contraception during and after a certain period of taking this medication. If you are nursing, this medication should also be avoided as it is excreted in breast milk. The safety of this medication in infants under 6 months of age has not been sufficiently established, so it should only be administered cautiously when necessary. Caution should be exercised when driving or operating machinery, as this medication can cause dizziness or seizures. In case of overdose, hallucinations or abnormal behavior may occur, and immediate consultation with a medical facility for appropriate treatment is required. This medication is primarily excreted through urine; thus, ensuring sufficient fluid intake and, if necessary, blood dialysis may help. Finally, while this medication can be mixed with various injection fluids, mixing with other medications or solutions is not recommended.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, 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, hepatocyte 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, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, hallucinations, paranoid behavior

This medication should be stored in a sealed container to avoid exposure to air and should be kept at room temperature between 1 degree and 30 degrees C. Proper storage will help maintain the drug's efficacy and prevent degradation.

Appearance

A clear, colorless solution contained in a polypropylene vial for injection.

Package unit

50 mL/bottle