Fluazole Capsule (Fluconazole)

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. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) 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. 2) Chronic atrophic oral candidiasis (oral pain 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 concomitantly. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): 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. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this drug as a single dose on the first day, followed by 200 mg once daily from the next day; the dose may be increased to 400 mg once daily according to 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 is 400 mg of this drug as a single dose 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 continued for at least 6 ~ 8 weeks. 5. 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. 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 level of 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, 400 mg should be administered starting 5-6 days before the onset of neutropenia is expected, and 400 mg should be 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 fingernails or toenails have grown). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous fungal 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 infection. 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 needed when administering a single dose. However, when multiple doses are required, the usual dose should be administered only on the first day of treatment, and the dose should be adjusted as follows from the next day. 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 In patients receiving hemodialysis, 100% of the usual dose should be administered 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 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. Infants younger than 6 months: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine 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 relapse. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine 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 (e.g., peritoneal, endocardial, pulmonary, and urinary tract infections): Administer 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine 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. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed all initial treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose 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 oral syrup or give the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. People who are allergic to this medication or similar class of drugs should not use it. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication. Additionally, patients taking certain medications that could cause severe side effects should not use this medication. This medication contains lactose, so individuals who have issues digesting lactose should avoid it. There are circumstances that require caution while using this medication. Patients with a history of drug allergies, kidney or liver problems, heart diseases, or electrolyte imbalances should use this medication with caution. Also, when taking this medication in conjunction with certain other medications, careful monitoring as per doctor’s guidance is required. This medication can interfere with drug metabolism in the liver, and concomitant use with other drugs can raise drug levels, leading to side effects. Generally, this medication is well tolerated, but rarely blood, liver, kidney issues or side effects like skin rash, digestive disturbances, and headaches may occur. Serious adverse effects such as arrhythmias have been reported rarely, so if symptoms appear, immediate consultation with a healthcare professional is necessary. While taking this medication, regular blood tests, liver function tests, and kidney function tests are recommended. Particularly, as there is a risk of liver function deterioration, any unusual signs should be reported immediately. Patients with heart diseases should monitor their heart condition through electrocardiograms. This medication can interact with various drugs, so it is essential to inform healthcare providers about all medications being taken. Some drugs should not be co-administered, while others may require dose adjustment or caution. Women who are pregnant or planning to become pregnant should not take this medication, and effective contraception should be practiced during the treatment period and for some time afterward. Breastfeeding women should also avoid taking this medication. Safety has not been established for infants less than 6 months old, so it should only be used with caution when absolutely necessary. Dizziness or seizures may occur when taking this medication, so caution should be exercised when driving or operating machinery. In case of overdose, hallucinations, or abnormal behavior may occur, and immediate medical attention should be sought. This medication is mainly excreted through urine, so adequate hydration and, if necessary, dialysis treatment may be helpful.

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, bloating, dry mouth, ALT increase, AST increase, elevated serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius (34 to 86 degrees Fahrenheit), which can help preserve the medication's effectiveness.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle