Fluconazole 50 mg Capsule

Adult dosage

The route of administration is 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 injectable formulations are the same. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg of this drug 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 of this drug once daily for 14 days, and local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, excluding vaginal candidiasis; noninvasive bronchopulmonary infections; candiduria; mucocutaneous candidiasis, etc.): The usual dose is 50 mg of this drug 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, and genitourinary infections, etc.): The usual dose is 400 mg of this drug once on the first day, followed by 200 mg once daily from the next day. The dose may be increased to a maximum of 400 mg once daily according to the patient's response. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug 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, administer 200 mg of this drug once daily indefinitely after the patient has completed all primary treatment. 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 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 an expected prolonged period of neutropenia. In these patients, administer 400 mg beginning 5-6 days before the onset of neutropenia is expected, 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 approximately 6-12 months for a toenail; the growth rate may vary from person to person and with age. In some cases, the fingernails or toenails may remain damaged even after successful treatment with long-term administration. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this drug 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. 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 unchanged. No dose adjustment is necessary 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 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 undergoing 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 a maximum of 400 mg. The safety and efficacy in infants younger than 6 months have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. 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, and genitourinary infections, etc.): Administer 6-12 mg/kg once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this drug on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all primary treatment. In pediatric patients with renal impairment, the dosing interval should be extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. When administering a dose of less than 10 mg, administer the syrup orally or inject the injectable formulation intravenously according to the child's clinical condition to ensure an accurate dose.

This medication should not be administered to certain patients. For example, individuals with allergies to this medicine or similar components, and women who are pregnant or breastfeeding should not use it. Additionally, patients taking certain medications may risk adverse effects when combined with this drug; therefore, it is essential to consult a doctor. Special caution should be taken when used with medications that affect the heart, certain antibiotics, and antihistamines. This drug contains lactose, so patients with lactose intolerance or related genetic conditions should avoid using it. Patients with renal or liver dysfunction need caution while using this medication, and regular testing is necessary due to the potential for liver function deterioration. Patients with heart disease or electrolyte imbalances may experience heart irregularities such as arrhythmias; thus, it should be used with care. It is important to periodically check the patient's status through liver and kidney function tests, and blood tests during treatment. Also, this medication may interact with several drugs; therefore, patients taking other medications must inform healthcare providers, and dosage adjustment or monitoring may be necessary. Pregnant women should avoid using this medication, and women of childbearing potential should use effective contraception during treatment and for one month after the last dose. Breastfeeding women are also advised against taking this medication. The safety of this drug in children, especially infants under 6 months old, has not been established; thus, it should be used cautiously when necessary. When taking this medication, it is advisable to be careful with activities such as driving or operating machinery, as dizziness or seizures may occur. In the case of an overdose, hallucinations or unusual behavior may occur; immediate consultation with healthcare providers is necessary, and supportive care and gastric lavage may be needed, if required. This drug is primarily excreted through urine; hence, adequate fluid intake to help facilitate excretion is beneficial. Additionally, its concentration can be reduced through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, dysgeusia, tremors, lightheadedness, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatic necrosis, hepatitis, hepatic injury, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, hallucinations, psychotic behavior

This medication must be stored in a tightly sealed container to prevent exposure to air or humidity. It is important to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature to safely preserve its effectiveness.

Appearance

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

Package unit

30 capsules/bottle