FLEX 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 injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this medicine 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 of this medicine 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 medicine 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 medicine 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 of this medicine 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 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 medicine once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on the patient’s risk of developing a 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 the anticipated onset of neutropenia, 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 fingernail or toenail has regrown (until an uninfected new nail has grown). Regrowth of a new fingernail generally takes 3-6 months, and a toenail takes 6-12 months; growth rates may vary from person to person and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete’s foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete’s foot may need to continue for 6 weeks, depending on its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults When 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary when it is administered only once. If 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 Creatinine clearance (mL/min) 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, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Pediatric patients Pediatric doses based on adult doses are generally determined according to the following guidelines and 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: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. To prevent relapse, treatment should continue for at least 2 weeks. 2. 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 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 once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. 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 depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all initial treatment. 6. Pediatric patients with renal impairment should have their dosing intervals extended and doses reduced according to the same guidelines used for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

It is crucial to avoid this medication in certain patients. For example, individuals who are allergic to this drug or similar medications, as well as pregnant or breastfeeding women, should not take this medication. Additionally, serious side effects may occur when taken with certain other medications, so it must be avoided. Patients with kidney or liver dysfunction, heart disease, or those at risk of arrhythmias should exercise special caution when using this medication. It should also be administered carefully in cases of drug hypersensitivity. This medication is generally well tolerated, but rarely, it can affect blood, liver, and kidneys and may cause side effects such as skin rash or gastrointestinal symptoms. In severe cases, liver damage or cardiac arrhythmias may occur, and any abnormal symptoms should be reported to healthcare professionals immediately. During the course of this medication, regular blood tests and liver and kidney function tests should be conducted, especially in patients with severe illnesses who need closer observation. Furthermore, this medication can affect heart rhythm, so patients with a history of heart disease should always consult healthcare professionals. This medication can interact with various other drugs, so if there are other medications being taken, it is essential to inform a doctor or pharmacist. Co-administration may require dosage adjustments or monitoring. Women who are pregnant or may become pregnant should use effective contraception during and for a period after taking this medication, and breastfeeding women are advised not to take this medication. Safety in children, especially infants under 6 months old, has not been established, so it should only be used cautiously when necessary. Caution is advised while driving or operating machinery, as dizziness or seizures may occur during medication use. In case of an overdose, hallucinations or abnormal behavior may manifest, and immediate contact with medical facilities is necessary for appropriate treatment, and, if necessary, blood dialysis may be performed to help remove the drug.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, distension, dry mouth, elevated ALT, elevated AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte 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, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, bizarre behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Capsules with a blue upper part filled with white powder and a white lower part

Package unit

30 capsules/bottle, 100 capsules/bottle