Flokan Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral preparations are rapidly and almost completely absorbed; therefore, the doses of oral preparations (capsules, dry syrup) and injectable preparations are the same. 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 caused by dentures): The usual dose of this drug is 50 mg once daily for 14 days, together with local disinfection of the dentures. 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; 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 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 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, after the patient has completed primary therapy, administer 200 mg of this drug once daily indefinitely. 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 of this drug 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 beginning 5-6 days before the expected onset of neutropenia, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary by individual and age. Even after successful treatment with long-term administration, 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 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. ○ 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 increased. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. No dosage adjustment is necessary when administering a single dose. However, if 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 undergoing 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

Pediatric doses corresponding to adult doses: Adult dose 100 mg: 3 mg/kg Adult dose 200 mg: 6 mg/kg Adult dose 400 mg: 12 mg/kg Do not exceed 400 mg. The safety and efficacy in infants younger than 6 months have not been established. 1. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. To prevent relapse, treatment should be continued for at least 2 weeks. 2. Esophageal candidiasis: 6 mg/kg of body weight 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 (e.g., peritoneal, endocardial, pulmonary, and urinary tract infections): 6-12 mg/kg of body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg of body weight 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. Treatment should be continued 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 of body weight once daily after the patient has completed all primary treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adult patients with renal impairment. When administering doses below 10 mg, administer the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals who are allergic to this drug or similar medications, pregnant women or those at risk of pregnancy, and breastfeeding women should not take this medication. Additionally, patients taking specific other medications should not use this drug in conjunction. This medication contains lactose and is not suitable for individuals with lactose intolerance or related genetic disorders. When using this medication, patients with kidney or liver function problems, heart disease, or electrolyte disturbances at risk of arrhythmia should exercise caution. Also, when taken with certain medications, dosage adjustments or monitoring may be necessary. This medication is generally safe, but some patients may experience changes in blood, liver, or kidney function, so regular tests during treatment are necessary. Rarely, side effects such as skin rash, liver dysfunction, cardiac arrhythmias, and neurological abnormalities may occur, so if you experience any abnormal symptoms, consult your physician immediately. Pregnant or breastfeeding women should avoid this medication, especially in early pregnancy, as there is a risk of congenital anomalies to the fetus. Women of childbearing age should ensure effective contraception during and for a certain period following treatment. This medication has not established safety and efficacy in children, particularly infants under 6 months, and should only be used cautiously when necessary. Dizziness or seizures may occur when driving or operating machinery, so caution is warranted. Overdose may lead to hallucinations or abnormal behavior, so follow the prescribed dosage accurately and contact medical services immediately in case of overdose. This medication is primarily excreted unchanged in urine, and blood dialysis can be utilized if necessary to reduce drug concentration.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT elevation, AST elevation, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular 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 reactions with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container to prevent leakage. Furthermore, it must be stored at room temperature between 1 degree and 30 degrees Celsius to maintain its efficacy.

Appearance

Capsule filled with white powder with the upper part in blue and the lower part in white

Package unit

30 capsules/bottle, 100 capsules/bottle