Fluconazole Capsule (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 injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this drug 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 of this drug is 50 mg once daily for 14 days, and 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 drug 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 of this drug 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 should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug 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 should be determined by the clinical and mycological response, but treatment should usually be administered for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily, depending on the patient's degree of risk of developing a fungal infection. For patients at very high risk of systemic fungal infections, such as those with severe neutropenia or an anticipated prolonged duration of neutropenia, as in the case of bone marrow transplantation, 400 mg once daily is recommended. In these patients, 400 mg should be administered starting 5-6 days before the anticipated onset of neutropenia, and 400 mg should be continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 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 6-12 months; the rate of growth may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug is 50 mg 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 infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. If renal impairment is present (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. No dosage adjustment is necessary for a single dose, but 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. Infants younger than 6 months: Safety and efficacy have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine 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. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine 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. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine 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. 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 body weight once daily after the patient has completed the full course of initial 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. When administering a dose of less than 10 mg, administer the syrup orally or inject the solution 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 taken by individuals who are allergic to this medication or similar drugs, or by pregnant or breastfeeding women. Caution is required as serious side effects can occur when taken in conjunction with certain medications. Patients with lactose intolerance or specific metabolic disorders should also avoid this medication. This medication should be used with caution in patients with impaired kidney or liver function, or those with heart disease or at risk of arrhythmia. Especial care should be taken when used with other medications due to increased risk of side effects from drug interactions; follow doctor’s advice. Generally safe, but adverse reactions may rarely occur in blood, liver, or kidneys. Gastrointestinal symptoms such as headache, abdominal pain, diarrhea, vomiting, and skin reactions like rash, pruritus may also occur. If any unusual symptoms appear, consult medical personnel immediately. Pregnant women are advised against taking this medication, and women of childbearing potential should ensure effective contraception during and for a period after treatment. Breastfeeding women are also recommended to avoid this medication. Safety in children, especially in infants under 6 months, has not been sufficiently confirmed and should only be used under a doctor's discretion when necessary. During treatment with this medication, caution should be exercised as dizziness or seizures may occur when driving or operating machinery. Overdose may cause hallucinations or abnormal behaviors, requiring immediate medical attention. This medication is primarily excreted through urine; adequate fluid intake and, if necessary, hemodialysis may be helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, increased ALT, increased AST, increased blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocyte 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, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 degree to 30 degrees Celsius. Proper storage maintains the medication's efficacy and prevents deterioration.

Appearance

A hard capsule with a blue upper part and white lower part containing white powder and granules.

Package unit

30 capsules/bottle, 100 capsules/bottle