Fluconazole Capsule 50 mg

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 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 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 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 once on the first day, followed by 200 mg once daily from the next day; the dose may be increased to up 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. 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 from the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should usually be given for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer this drug at 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 this drug at 50-400 mg once daily according to the patient's level of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those undergoing bone marrow transplantation who have severe neutropenia or are expected to have prolonged neutropenia. 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 more. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary between individuals and according to age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophytosis, 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. ○ Older adults 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 increased. ○ Patients with renal impairment This drug is excreted primarily in the urine unchanged. No dose adjustment is needed when it is administered as 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 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 on 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. Safety and efficacy have not been established in infants younger than 6 months. 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. 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 according to 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.): 6-12 mg/kg body weight once daily. The duration of treatment is determined according to 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 according to the patient's response. 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. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as for adults with renal impairment. When administering doses below 10 mg, to ensure an accurate dose, administer the syrup orally according to the child's clinical condition or administer the injection intravenously.

This drug should not be used for certain patients. For example, those who have had allergic reactions to this drug or similar medications should avoid taking it. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this drug as it may affect the fetus or infant. Additionally, patients already taking certain medications may experience severe side effects if they use this drug together, so caution is advised. Patients with lactose intolerance or genetic lactose-related issues should also avoid this medication. Those with kidney or liver dysfunction, cardiovascular disease, or electrolyte abnormalities should use this drug with extra care, as they may face a risk of heart rhythm problems. Moreover, this drug may interact with other medications; therefore, any ongoing medications should be discussed with a doctor or pharmacist. Rarely, this medication can cause various side effects, including blood abnormalities, allergic reactions, liver dysfunction, skin rashes, and digestive disturbances. If any abnormal symptoms occur, seek medical advice immediately. Particularly due to potential liver dysfunction, regular liver function tests during treatment are recommended. During pregnancy, taking this medication can increase the risk of congenital malformations or spontaneous abortion, so it should be avoided. Nursing mothers should also refrain from using this drug as it can be transferred to breast milk and affect the baby. For infants under 6 months of age, the safety and efficacy of this drug have not been conclusively established, so it should only be used if necessary. When taking this drug, symptoms such as dizziness or seizures may occur, so caution is recommended when driving or operating machinery. In case of an overdose, hallucinations or unusual behavior may occur, requiring immediate medical attention. Decontamination or symptomatic treatment may be necessary, and blood dialysis can lower drug concentration.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsades 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, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, 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, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Moreover, avoid storing it in too hot or too cold conditions, ideally maintaining a storage temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle