Fluconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because the oral formulation is rapidly and almost completely absorbed, the doses of the oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose. Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine 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 of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this medicine 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 of this medicine 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 by clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine 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 should generally continue for at least 6 ~ 8 weeks. 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. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on the patient's level of risk for 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 expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis, administer 150 mg once weekly until the fingernail or toenail has regrown (until a new, uninfected nail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a new toenail; growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day, and adjust the dose from the next 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 receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced 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. The safety and efficacy in infants under 6 months of age have not been established. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day; administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day; depending on the patient's response, the dose may be increased to 12 mg/kg body weight 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 body weight once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily from the next day; depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily; administer for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed primary treatment. Children with renal impairment should have their dosing intervals extended and doses reduced according to the same criteria used for adults with renal impairment. When administering doses of less than 10 mg, syrup should be given orally or the injection should be administered intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, it should not be administered to individuals allergic to this drug or similar substances, or to pregnant or breastfeeding women. Additionally, it can pose risks when taken with certain medications, so it is important to inform your healthcare provider about any current medications being taken. This medication contains lactose, and patients with lactose intolerance should avoid it. Caution is necessary for patients with kidney or liver problems, and patients with heart disease or abnormal heart rhythms should also be cautious. Since this medication can affect liver function, it is essential to undergo liver function tests during treatment. Furthermore, this drug can interact with various medications, so if there are other medications being taken, consultation with a physician or pharmacist is advised. Women who are pregnant or may become pregnant should use effective contraception during and for one month after taking this medication. Nursing women should avoid taking this medication as it may be transferred to breast milk. Its safety for young children, especially infants under 6 months, has not been established and should only be administered in special cases. Caution is advised while driving or operating machinery, as dizziness or seizures may occur during treatment. In cases of overdose, hallucinations or abnormal behavior may manifest, and immediate contact with a healthcare institution is necessary for appropriate symptom management.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is also recommended to keep the medication at room temperature between 1°C and 30°C.

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