Yuyu Fluconazole 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 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 discomfort 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, and mucocutaneous candidiasis, 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 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 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 the full course of 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 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 anticipated 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 nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; the growth rate may vary from person to person and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Skin 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 its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults 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 extended. ○ Patients with renal impairment This drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for 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 on dialysis): 50% of the usual dose Hemodialysis patients: 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 Pediatric doses based on adult doses are generally determined according to the following criteria and must 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 Infants under 6 months of age: Safety and efficacy have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: 6 mg/kg on the first day, then 3 mg/kg once daily from the following day; do not exceed 400 mg. Treatment should be continued for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: 6 mg/kg on the first day, then 3 mg/kg once daily from the following day; depending on the patient's response, the dose may be increased to 12 mg/kg once daily; do not exceed 400 mg. 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 once daily; do not exceed 400 mg. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg on the first day, then 6 mg/kg once daily from the following day; depending on the patient's response, the dose may be increased to 12 mg/kg once daily; do not exceed 400 mg. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed all primary treatment, administer 6 mg/kg once daily; do not exceed 400 mg. 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 a dose of less than 10 mg, to ensure accurate dosing, administer the syrup orally or the injection intravenously, depending on the child's clinical condition.

This medication should not be used in certain patients. For example, it should not be administered to individuals who are allergic to this drug or similar substances, pregnant women, or nursing mothers. Moreover, patients with heart disease or issues with kidney or liver function, and individuals taking certain medications should use this medication cautiously. Patients at risk of arrhythmias should be particularly careful due to the potential impact on heart rhythm. This medication may affect liver and kidney functions, so it is advisable to undergo blood tests, liver function tests, and kidney function tests before and during treatment. It may interact with various medications, therefore anyone taking other drugs must consult with a doctor or pharmacist. Special care is needed when taking this drug with medications affecting the heart, anticoagulants, antidepressants, certain antibiotics, and immunosuppressants. Pregnant women should avoid using this medication as it may harm the fetus, and women of childbearing age should use effective contraception during and after treatment. Nursing mothers are also advised against this medication as it can be transmitted through breast milk. In children, especially infants under 6 months old, its safety and effectiveness have not been established, and it should only be used when absolutely necessary. During treatment with this drug, caution is advised while driving or operating machinery as dizziness or seizures may occur. Overdosage may cause hallucinations or abnormal behavior; immediate medical assistance should be sought for appropriate treatment. This medication is primarily excreted through urine, thus adequate fluid intake can be beneficial.

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, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized pustular dermatitis, exfoliative dermatitis, facial swelling, hair loss, drug reactions accompanied by eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air or humidity, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This will help preserve the medication's efficacy for a longer time.

Appearance

A capsule with a sky blue upper part and a white lower part filled with white powder.

Package unit

30 capsules/bottle