Fluconazole Capsule

Adult dosage

The route of administration is 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 injectable formulations are the same. 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 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, and local disinfection of the dentures should be performed concomitantly. 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. 3. 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 up to 400 mg once daily according to the patient's response. The duration of treatment is determined according to clinical response and medical judgment. 4. 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 should usually be given for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed all initial treatment. 6. 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 degree 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 those undergoing bone marrow transplantation, or those expected to have severe or prolonged 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 higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary between individuals and with age. In some cases, nails may remain damaged even after successful treatment with long-term administration. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may be required for 6 weeks, depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. For 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 drug is excreted mainly in the urine unchanged. No dosage adjustment is needed for a single dose; however, when multiple doses are required, administer the usual dose only on the first day 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 receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, 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 400 mg. Infants under 6 months of age: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. Administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/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 resolution of symptoms. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): 6-12 mg/kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, then 6 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/kg of body weight 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 of body weight once daily after completion of the patient's initial treatment. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as adult patients with renal impairment, depending on the degree of renal impairment. For doses below 10 mg, administer the oral solution orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This drug is an azole antifungal primarily used to treat Candida infections. It should not be administered to certain patients; for instance, those with a history of allergic reactions to this drug or similar drugs, pregnant or potentially pregnant women, and nursing mothers should not use it. Severe side effects may occur when taken with certain drugs, so co-administration is prohibited. For example, it should not be taken with drugs that affect cardiac rhythm or interact with this drug. This drug contains lactose, therefore it should not be given to patients with lactose intolerance or related genetic conditions. Patients with decreased kidney or liver function, heart disease, or electrolyte imbalance should be especially cautious when using this drug, as close monitoring and testing by a physician may be required. While this drug is generally well-tolerated, it can rarely cause abnormalities in blood, liver, or kidney function, as well as skin rash, headaches, gastrointestinal symptoms, etc. If liver function abnormalities are suspected, the decision to use this drug should be made cautiously, and regular testing of liver enzyme levels during treatment is essential. This drug may cause QT interval prolongation, so patients with heart disease or electrolyte abnormalities should be carefully monitored. This drug interacts with many other medications, so those taking other drugs must inform their doctor or pharmacist, and dosage adjustments or monitoring may be necessary. It is safest for pregnant or breastfeeding women to avoid this drug, and fertile women should employ effective contraception during and for a period after taking this drug. Its safety has not been established in infants under 6 months of age, so it should be used with caution only when necessary. Caution should be taken when driving or operating machinery as this drug may cause dizziness or seizures. In case of overdose, hallucinations or abnormal behavior may occur, and immediate medical care should be sought. This drug is primarily excreted in the urine, so in cases of overdose, blood dialysis may be used to lower its concentration in the body.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory abnormalities, taste abnormalities, tremors, 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, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial swelling, hair loss, drug reactions accompanied by eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius (room temperature).

Appearance

Hard capsule with upper light blue and lower white, filled with white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle