Flucazol Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral preparations are absorbed rapidly and almost completely, the doses of oral preparations (capsules, dry syrup) and injectable preparations 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 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 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 based on clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg 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 generally 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 initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infection 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 degree 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 infection, such as those with severe neutropenia or an anticipated prolonged period of neutropenia, as in the case of 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 higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary by individual and 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 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 condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose may 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 in unchanged form. Dose adjustment is not necessary for 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 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 days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined using the following criteria and should not exceed a maximum of 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 Infants under 6 months of age: Safety and efficacy have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Treatment should be continued for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: Administer 6 mg/kg of this medicine 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 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.): Administer 6-12 mg/kg once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of this medicine 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 according to 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 once daily after the patient has completed the initial treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, use oral syrup, according to the child's clinical condition, or administer the injection intravenously to ensure accurate dosing.

This medication should not be administered to specific patients. Patients with a history of allergic reactions to this medication or other azole drugs, pregnant women or those who may become pregnant, and breastfeeding women should not take this medication. Additionally, serious side effects may occur when taken with certain medications, so co-administration is prohibited. This medication contains lactose, and patients with lactose intolerance or related genetic disorders should not take it. Patients with renal or liver impairment, those at risk of arrhythmias due to heart disease or electrolyte abnormalities, and those with a history of drug hypersensitivity should use this medication with caution. This medication can affect liver function, so regular liver function tests should be conducted. Moreover, this medication can interact with many other drugs, so it is important to inform healthcare professionals of any other medications being taken. This medication is generally well tolerated, but rarely, blood abnormalities, allergic reactions, liver function abnormalities, skin rashes, and gastrointestinal symptoms may occur. There is also a risk of cardiac rhythm abnormalities, so patients with heart disease should be cautious. It is advisable not to use this medication during pregnancy, and women of childbearing age should use effective contraception during and for some time after taking this medication. Breastfeeding women are also advised not to take this medication. Safety in children, especially infants under 6 months of age, has not been fully established, so it should only be administered with caution when necessary. Dizziness or seizures may occasionally occur while taking this medication; therefore, caution is needed when driving or operating machinery. In cases of overdose, hallucinations or abnormal behavior may occur, so medical attention should be sought immediately for appropriate treatment. This medication is primarily excreted in urine, so adequate hydration is recommended, and dialysis may be used to reduce drug concentration if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, 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, elevated 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 (DRESS), myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly closed container to prevent air or humidity from entering. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle