Fluconazole Capsule 50 mg

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. 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral 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 concurrently. 3) 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. 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; depending on the patient's response, the dose may be increased to 400 mg once daily. 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 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. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed primary 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 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 with severe or prolonged neutropenia, as may occur with bone marrow transplantation. In these patients, 400 mg should be administered 5-6 days before the anticipated onset of neutropenia and 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). It usually takes 3-6 months for new fingernails to grow and 6-12 months for toenails; growth rate may vary by age and individual. Even after successful treatment with long-term administration, fingernails or toenails may occasionally remain damaged. For 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, athlete's foot may require treatment for 6 weeks, depending on the clinical course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, the usual adult dose should be 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 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 non-dialysis days, 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. The safety and efficacy of this medicine have not been established in infants younger than 6 months. 1. Oropharyngeal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Treatment should be continued for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. The dose may be increased to 12 mg/kg of body weight once daily depending on the patient's response. 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 of body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of body weight of this medicine on the first day, followed by 6 mg/kg of body weight once daily from the next day. The dose may be increased to 12 mg/kg of body weight once daily depending on 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 the patient has completed all initial therapy. 6. Pediatric patients with renal impairment should have their dosing intervals extended and doses reduced according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. When administering doses 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 administered to individuals who are allergic to this medication or its components, pregnant women or those who may become pregnant, and nursing mothers. Patients taking specific medications that may interact with this drug should also avoid its use. This medication contains lactose, and therefore should not be administered to patients with lactose intolerance or related genetic disorders. Patients with renal or liver impairment, those with heart disease or electrolyte imbalances that present a risk of arrhythmias need to exercise caution when using this medication. Additionally, this drug may inhibit certain enzymes, which can increase the blood concentration of other drugs, necessitating dosage adjustments or monitoring depending on the concomitant medications. Although this medication is generally safe, side effects such as headache, abdominal pain, diarrhea, altered liver function, and skin rashes may occur. Rarely, serious side effects such as severe liver damage or cardiac arrhythmias have been reported. Therefore, regular blood tests and assessments of liver and kidney function during treatment are recommended. The use of this medication should be avoided during pregnancy, particularly high doses in early pregnancy as this can increase the risk of fetal malformations. It is also safer for nursing mothers to avoid taking this drug. The safety of this medication in children, particularly in infants under 6 months, has not been fully established; it should be used cautiously only when necessary. During the use of this drug, dizziness or seizures may occasionally occur, necessitating caution when driving or operating machinery. In the case of overdose, hallucinations or abnormal behavior may occur, requiring appropriate treatment and support. This drug is primarily excreted in urine, so increasing fluid intake may assist elimination, and in cases of need, blood dialysis can lower drug concentration.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremors, vertigo, Torsade 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, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular injury, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions accompanied by eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a tightly closed container, protected from air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the drug's efficacy and safety.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle