Wungconazole Capsule 50 mg (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 as a single oral 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 soreness caused by dentures): The usual dose is 50 mg of this drug 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 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 from the next day by 200 mg once daily. The dose may be increased to 400 mg once daily depending on 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 from the next day by 200-400 mg once daily. 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 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 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. Continue treatment 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 between individuals and according to 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 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 should be extended. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. No dose adjustment is necessary when administering a single dose. However, when multiple doses are required, administer the usual dose on the first day only, 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

○ Children The following criteria are generally used to determine the pediatric dose based on the adult dose; do 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: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. Administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): 6-12 mg/kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, then 6 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/kg of body weight once daily depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. Prevention of relapse of cryptococcal meningitis in patients with AIDS: 6 mg/kg of body weight once daily after the patient has completed all initial treatment. 6. In children 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 syrup orally or inject the solution intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medicine should not be administered to certain patients. For example, it should not be used in individuals allergic to this medicine or other similar drugs, in pregnant or nursing women, and in patients taking certain heart disease medications. Patients with compromised kidney or liver function and those with heart disease or at risk for arrhythmias should use it cautiously. Patients with a history of drug hypersensitivity also require caution. Overall, this medicine is well tolerated, but rare adverse reactions related to blood, liver, kidney disorders, skin rash, headache, gastrointestinal symptoms may occur. If signs of liver function abnormalities appear, consult a physician immediately. During treatment with this medication, regular blood tests and kidney and liver function tests are recommended. Monitoring is also necessary as there have been reports of adrenal insufficiency. This medicine may cause QT interval prolongation related to heart rhythm; therefore, patients with heart disease or hypokalemia should be particularly cautious. This medication may interact with several other drugs. Patients taking other medications must inform their doctor or pharmacist, and co-administration with certain drugs may need to be avoided or require dosage adjustments. Women who are pregnant or may become pregnant should use effective contraception while taking this medicine, and nursing mothers should avoid its use for safety. For infants under 6 months of age, the safety and efficacy of this medicine have not been sufficiently established and should only be used if absolutely necessary. Dizziness or seizures may occur during the use of this medication when driving or operating machinery, so caution is needed. In case of overdose, hallucinations or unusual behavior may appear, and immediate medical assistance should be obtained, including possible supportive treatment and gastric lavage or hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, pruritus, 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, malaise, asthenia, fever, adrenal insufficiency, hallucinations, agitated behavior

This medicine should be stored in a tightly closed container to prevent air from entering and should be kept at a temperature between 1 and 30 degrees Celsius. Proper storage will maintain its effectiveness and prevent degradation.

Appearance

This medicine is a hard capsule with a blue-green upper part and a yellowish-brown lower part containing white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle