Fluconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of oral formulations (capsules, dry syrup) and injections are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral 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 due to 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 infection, 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 once on the first day, followed by 200 mg once daily starting 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 should be determined based on the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should generally continue 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 infection due to neutropenia resulting from 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. 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 period of neutropenia, as in the case of bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before the onset of neutropenia is expected, and continued for 1 week after the neutrophil count has increased to ≥1,000 cells/mm3. 7. For onychomycosis of the fingernails and toenails, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate 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 its course. 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. In patients with renal impairment (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 in unchanged form. No dose adjustment is necessary when administering 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 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

○ Children The following guidelines generally apply to pediatric doses based on the adult dose, and the dose should 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, safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. Do not exceed 400 mg. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily depending on the patient's response. Do not exceed 400 mg. 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.): 6-12 mg/kg body weight once daily. Do not exceed 400 mg. The duration of treatment is determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily depending on the patient's response. Do not exceed 400 mg. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed all initial treatment. Do not exceed 400 mg. 6. In children with renal impairment, extend the dosing interval and reduce the dose according to the degree of renal impairment, following the same criteria as for adults with renal impairment. When administering doses below 10 mg, administer the syrup orally or inject the solution intravenously, according to the child's clinical condition, to ensure accurate dosing.

This drug should not be administered to certain patients. For instance, patients with an allergy to this medication or similar components, pregnant or potentially pregnant women, and nursing mothers should not use this medication. Additionally, serious side effects may occur if taken with specific medications, so it should not be combined with drugs that can affect heart rhythm, certain antibiotics, or drugs related to heart disease. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic conditions. Patients with renal or liver function issues, a history of drug allergies, cardiovascular disease, or electrolyte imbalances should exercise special caution when using this drug, as it may worsen liver function and present side effects such as cardiac arrhythmias. While this medication is generally well tolerated, rare adverse reactions may occur involving blood, the immune system, the nervous system, the heart, liver, and skin. Reports have included headaches, rashes, increased liver enzymes, abnormal heart rhythms, gastrointestinal symptoms, etc. During treatment, it is important to undergo regular blood tests, liver function tests, and renal function tests. If liver enzymes significantly increase, the administration of this medication should be re-evaluated. This medication has many drug interactions, so care should be taken when taken with other medications. Some drugs may alter the blood concentration of this medication, which may necessitate dose adjustment or monitoring. It is advisable not to use this medication during pregnancy, and fertile women should ensure effective contraception during the period of use and for a certain time afterward. Nursing mothers should also not use this medication. Safety in infants under 6 months of age has not been established, so it should only be used cautiously in special cases. Caution is necessary when driving or operating machinery, as dizziness or seizures may occur due to this medication. In case of overdose, hallucinations or abnormal behavior may occur, so it is essential to contact a medical institution immediately, and depending on the situation, gastric lavage or supportive care may be necessary. This drug is primarily excreted in the urine, so adequate fluid intake may be helpful, and some can be removed by dialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocyte damage, rash, pruritus, urticaria, increased sweating, drug eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness for an extended time.

Appearance

A capsule filled with white powder, with a blue upper part and a white lower part.

Package unit

30 capsules, 100 capsules (bottle)