Huranal Injection (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Absorption of the oral formulation is rapid and nearly complete; therefore, the doses of the oral formulations (capsules, dry syrup) and the injection are the same. Administer this drug intravenously 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 due to dentures): The usual dose is 50 mg once daily for 14 days. 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 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, urinary tract, 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 by 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 generally given 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 course of 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, 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 infection, such as those with severe neutropenia or an anticipated prolonged duration of neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg beginning 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. Elderly patients: Use the usual adult dose only if renal function is normal. 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 necessary for a single dose. For multiple doses, administer the usual dose on the first day only, 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 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Children's dosage

Do not exceed a maximum of 400 mg. 100 mg: 3 mg/kg 200 mg: 6 mg/kg 400 mg: 12 mg/kg The safety and efficacy in infants younger than 6 months have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg on the first day, followed by 3 mg/kg once daily from the next day. Treatment should be given 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 according to 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, urinary tract, etc.): Administer 6 - 12 mg/kg once daily. The duration of treatment is determined by 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 according to 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 the initial course of treatment. Children with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as for adults with 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 is an azole antifungal and should not be used in certain patients. Patients allergic to this drug or similar medications should not take it. Pregnant or breastfeeding women should also avoid this medication. Serious side effects may occur when taken with certain medications, so discuss any current medications with a doctor. Use with caution in patients with kidney or liver impairment, heart disease, or electrolyte imbalance, especially since it may affect heart rhythm in those with heart conditions. Regular monitoring of liver and kidney function and blood status is necessary while taking this medication to check for adverse reactions. There may be rare instances of liver damage or severe skin reactions; notify medical personnel immediately if skin rashes or jaundice occur. Due to high potential for drug interactions, this medication may affect the efficacy or side effects of other drugs taken concurrently, particularly with cardiovascular drugs, anticoagulants, certain antidepressants, immunosuppressants, and anticancer drugs. Medication adjustments and monitoring under a physician’s direction are essential during treatment. Avoid using this medication during pregnancy, and women of childbearing age should use effective contraception during treatment and for a period afterward. Nursing mothers should also avoid taking this medication. Safety in children, especially infants under six months, has not been established, thus should only be administered with caution when necessary. This medication may cause dizziness or seizures when driving or operating machinery; caution is advised during such activities. In the case of an overdose, hallucinations or abnormal behavior may arise, necessitating immediate visit to a medical facility, where adequate treatment and measures to increase urine excretion may help. When administering this medication mixed with a solution, it should only be mixed with certain solutions; mixing with other drugs or fluids is not recommended.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste alteration, tremor, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, 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 swelling, hair loss, drug reaction with eosinophilia and systemic symptoms (DRESS), myalgia, fatigue, lethargy, asthenia, fever, hallucinations, psychotic behavior

Store this medication in a sealed container to prevent air or moisture ingress, maintaining a storage temperature between 1 and 30 degrees Celsius. This way, the efficacy of the drug can be well maintained.

Appearance

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

Package unit

1 vial (50 milliliters x self-packaging unit)