Yukozol Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral preparations are absorbed rapidly and almost completely; therefore, the doses of oral preparations (capsules, dry syrup) and injectable preparations are the same. Vaginal candidiasis: A single oral dose of 150 mg of fluconazole 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. 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. 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. 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 according to clinical response and medical judgment. 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 usually continue for at least 6 ~ 8 weeks. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After the patient has completed all initial treatment, administer 200 mg of this drug once daily indefinitely. 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 for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, 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 expected onset of neutropenia, and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. Onychomycosis: Administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, while toenails take about 6-12 months; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte 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 disease. 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: No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day, and from the next day onward administer 100 % of the usual dose if creatinine clearance > 50 mL/min, 50% of the usual dose if ≤50 (not on dialysis), and 100% of the usual dose after each hemodialysis session for patients receiving hemodialysis. 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 dose equivalent to an adult dose of 100 mg: 3 mg/kg Pediatric dose equivalent to an adult dose of 200 mg: 6 mg/kg Pediatric dose equivalent to an adult dose of 400 mg: 12 mg/kg The pediatric dose should not exceed 400 mg. The safety and efficacy in infants younger than 6 months have not been established. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. Treatment should be continued for at least 2 weeks to prevent relapse. 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 up to 12 mg/kg 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. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, and urinary tract infections, etc.): 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. 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, depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After the patient has completed all initial treatment, administer 6 mg/kg body weight once daily. Pediatric patients with renal impairment should have their dosing intervals extended and doses reduced according to the same criteria as adult patients with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, to ensure accurate dosing, administer the syrup orally or the injection intravenously, according to the child's clinical condition.

This medication is an azole antifungal agent used for the treatment of fungal infections. This medication should not be administered to certain patients, such as those allergic to azole drugs, pregnant or breastfeeding women, and patients with specific heart diseases or liver conditions. Additionally, this medication contains lactose, so it should not be used in patients with lactose intolerance or related genetic issues. Patients with kidney or liver impairment, those at risk for cardiac arrhythmias, or those taking specific medications should use this drug cautiously. This medication may affect liver and kidney function, so it is important to perform regular blood tests and liver and kidney function tests before and during administration. This medication can cause changes in cardiac electrophysiology, increasing the risk of cardiac arrhythmias, so caution is needed for individuals with heart diseases or abnormal findings in electrocardiograms. There is a high potential for drug interactions with this medication, and dosage adjustments or monitoring may be necessary depending on other medications being taken. Particularly, caution should be taken when used in conjunction with drugs affecting the heart, anticoagulants, benzodiazepines, anticonvulsants, and immunosuppressants. Pregnant women should avoid using this medication due to the risk of congenital abnormalities in the fetus, and effective contraception must be used; this medication should not be administered during pregnancy. Breastfeeding women should also discontinue nursing or avoid using this medication as it is secreted into breast milk. The safety of this medication has not been established for pediatric patients, particularly infants under 6 months, and should be used with caution. When taking this medication, dizziness or seizures may occur, so caution is needed when driving or operating machinery. In cases of overdose, hallucinations or abnormal behaviors may appear, and appropriate treatment should be sought immediately from a medical institution. This medication is primarily excreted through urine, and in cases of overdose, it may be possible to remove the drug through hemodialysis.

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, abdominal distension, dry mouth, increased ALT, increased AST, increased blood 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 swelling, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

Store this medication in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer period.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle