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 injections are the same. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 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 concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., 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. 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 400 mg once daily depending on the patient's response. The duration of treatment should be determined according to the clinical response and medical judgment. 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 the 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, after completion of primary treatment, administer 200 mg once daily indefinitely. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg once daily depending on the patient's risk of 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 expected prolonged period of neutropenia, as in the case of bone marrow transplantation. 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 fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, 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, athlete's foot may require treatment for 6 weeks, depending on the course of the condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. For patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval increased. This drug is excreted mainly unchanged in the urine. No dose adjustment is needed when administering a single dose. For multiple-dose administration, administer the usual dose only on the first day, then 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, 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 a maximum of 400 mg. Infants younger than 6 months: Safety and efficacy 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. Treatment should continue 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. The dose may be increased to 12 mg/kg body weight once daily depending on the patient's response. Treat 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 should be determined according to the 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. The dose may be increased to 12 mg/kg body weight once daily depending on the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After completion of primary treatment, administer 6 mg/kg body weight once daily. Children with renal impairment should have their dosing interval increased and dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. When administering doses of less than 10 mg, syrup should be given orally or the injection administered intravenously, depending on the child's clinical condition, to ensure an accurate dose.

This medication should not be used in certain patients. For example, individuals who have had allergic reactions to this medication or similar medications, pregnant women or women who may become pregnant, and women who are breastfeeding should not take this medication. In addition, serious side effects may occur when this medication is taken with certain drugs, so patients currently taking such medications should avoid this drug. For example, it should not be taken with drugs that affect heart rhythm, some antihistamines, and certain antibiotics. This medication contains lactose and is not suitable for individuals with lactose intolerance or certain genetic metabolic disorders. Patients with poor kidney or liver function, those with heart disease, or electrolyte imbalances should use this medication cautiously and may require regular tests before and during administration. While this medication is generally safe to use, rare side effects may include decreased blood cell counts, allergic reactions, liver dysfunction, heart arrhythmias, gastrointestinal disorders, and skin rashes. Therefore, any unusual symptoms should be reported to a healthcare provider immediately. Additionally, this medication can interact with many other medications, so individuals taking other drugs must inform their doctor or pharmacist, and dosage adjustments or alternative medications may be considered if necessary. It is important to avoid taking this medication during pregnancy, especially in the early stages, as it may harm the fetus; thus, contraception is essential. Nursing mothers should also avoid taking this medication. The safety of this medication in children, especially infants under 6 months old, has not been established, so it should only be used cautiously when absolutely necessary. Finally, during the use of this medication, one should be cautious when driving or operating machinery as dizziness or seizures may occur. In case of an overdose, hallucinations or abnormal behaviors may occur, and immediate medical attention is required. This medication is mainly excreted through urine, so measures may be necessary to assist in excretion.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, dysgeusia, 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, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug eruption, 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, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. This storage condition helps maintain the drug's effectiveness for a long time and ensures safe use.

Appearance

Hard capsules with a blue upper part and a white lower part containing a white powder

Package unit

30 capsules/bottle, 100 capsules/bottle