Fruclan Injection (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. Adults 1) Mucosal candidiasis (1) Oropharyngeal candidiasis The usual dose of this medicine is 50 mg once daily for 7 - 14 days; treatment may be extended at the physician's discretion. (2) Chronic atrophic oral candidiasis (oral pain caused by dentures) The usual dose of this medicine 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 of this medicine is 50 mg once daily for 14 - 30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 2) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.) The usual dose of this medicine 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 according to the patient's response. The duration of treatment is determined according to the clinical response and medical judgment. 3) Cryptococcal meningitis and cryptococcosis at other sites The usual dose of this medicine 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 the clinical and mycological response, but treatment is generally continued for at least 6 - 8 weeks. 4) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. 5) Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50 - 400 mg of this medicine once daily according to the patient's risk of developing a fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as bone marrow transplant recipients with severe neutropenia or an expected prolonged duration of neutropenia. In these patients, administer 400 mg beginning 5 - 6 days before neutropenia is expected to start and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 3. Elderly patients The usual adult dose may be administered only if renal function is normal. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. 4. Patients with renal impairment This medicine is excreted primarily in the urine unchanged. No dose adjustment is required for a single dose; however, when multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the following day as follows: 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 on hemodialysis should receive 100% of the usual dose after each hemodialysis session; on days without dialysis, the dose should be reduced according to creatinine clearance.

Children's dosage

2. Pediatric patients Pediatric doses based on the adult dose are generally determined according to the following criteria 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, the safety and efficacy of this medicine have not been established in infants younger than 6 months (see Precautions for Use). 1) Oropharyngeal candidiasis Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 2) Esophageal candidiasis Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. The dose may be increased to 12 mg per kg of body weight once 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 - 12 mg per kg of body weight once daily. The duration of treatment is determined according to the clinical response and medical judgment. 4) Cryptococcal meningitis Administer 12 mg per kg of body weight of this medicine on the first day, followed by 6 mg per kg of body weight once daily from the next day. The dose may be increased to 12 mg per kg of body weight once daily according to the patient's response. Treatment should continue for 10 - 12 weeks after cerebrospinal fluid cultures become negative. 5) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg per kg of body weight once daily after the patient has completed primary treatment. 6) In pediatric patients with renal impairment, extend the dosing interval and reduce the dose 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, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals who are allergic to this drug or similar drugs, pregnant women, or nursing mothers should not take this medication. It should also be avoided when taken with other drugs that may cause heart problems. Particular caution should be observed for patients with renal or liver impairment, or those with heart disease or at risk of arrhythmias. While generally safe, rare adverse reactions may occur, affecting the blood, liver, skin, or nervous system. Patients with severe underlying conditions should undergo regular blood or liver function tests, and if liver enzyme levels significantly increase, they should consult their physician. Due to the high potential for drug interactions, patients should inform their physician or pharmacist of any other medications they are taking, particularly when combined with heart-related medications, anticoagulants, antibiotics, or anticonvulsants, as dosage adjustments and monitoring may be necessary. Women who are pregnant or may become pregnant must use effective contraception during and for at least one month after taking this medication, as it may harm the fetus. Nursing mothers should also avoid taking this medication. Safety for infants under 6 months of age is not well established, and it should only be used when absolutely necessary. Caution is needed when driving or operating machinery, as dizziness or seizures may occur. In the case of overdose, hallucinations or abnormal behavior may manifest, and immediate medical attention should be sought. This medication can be mixed with specific solutions for use, but mixing with other medications or fluids in advance is not recommended.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, taste disturbance, tremor, lightheadedness, Torsade 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 injury, 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, asthenia, fever, adrenal insufficiency, hallucination, 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 and 30 degrees Celsius.

Appearance

A vial injection containing a colorless and transparent liquid

Package unit

(50 mL/vial) X 1, (50 mL/vial) X 10