IYUN Fluconazole Capsule 50 mg

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. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg 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 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, and mucocutaneous candidiasis, excluding vaginal candidiasis): The usual dose 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 is 400 mg once 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 is 400 mg once 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 generally continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed all initial 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 once daily according to the patient's degree 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 with severe neutropenia or an anticipated prolonged period of neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or above. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). Fingernails usually take 3-6 months to regrow, and toenails take approximately 6-12 months; growth rates may vary by age and from person to person. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose 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 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 is 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 unchanged. No dose adjustment is necessary for a single dose. However, when multiple doses are required, administer the usual dose only on the first day of treatment, then adjust the dose from the following day as follows. Creatinine clearance (mL/min) Recommended dose > 50 100 % of the usual dose ≤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, administer a reduced dose according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on adult doses are generally determined according to the following criteria and should 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 under 6 months of age (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg per kg of body weight on the first day, then 3 mg per kg of body weight once daily from the following day. Administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: Administer 6 mg per kg of body weight on the first day, then 3 mg per kg of body weight once daily from the following day. The dose may be increased to 12 mg per kg of body weight once daily according to patient response. Administer for at least 3 weeks and for at least 2 weeks after resolution of symptoms. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg per kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg per kg of body weight on the first day, then 6 mg per kg of body weight once daily from the following day. The dose may be increased to 12 mg per kg of body weight once daily according to patient 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 per kg of body weight once daily after the patient has completed all initial treatment. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria used for adults with renal impairment, based on the degree of impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This drug should not be administered to certain patients. Those allergic to this drug or similar components, pregnant women or women who may become pregnant, and breastfeeding women should not use this drug. Also, patients taking specific medications with this drug should avoid its use. Since this drug contains lactose, caution is needed for those with lactose intolerance or related genetic disorders. This drug should be used carefully in individuals with a history of hypersensitivity reactions, or with problems related to kidney or liver function, or those at risk of arrhythmia due to heart disease or electrolyte imbalance. Special caution is needed for patients with heart disease since this drug may affect heart rhythm. Furthermore, since this drug inhibits certain enzymes, it may interact with other medications; therefore, it is necessary to consult with healthcare professionals if other medications are being taken. Those allergic to the dye contained in this drug should also use it cautiously. This drug is generally well tolerated, but in rare cases, adverse reactions involving the blood, immune system, metabolism, mental state, nervous system, heart, gastrointestinal tract, liver, skin, etc. may occur. In particular, liver function abnormalities, cardiac arrhythmia, or severe skin reactions have been reported, so if unusual symptoms occur, healthcare professionals should be notified immediately. Regular blood tests, liver function tests, and kidney function tests are recommended during the course of taking this drug. In particular, if liver enzyme levels significantly increase, reevaluation of the drug administration should be performed. Patients with heart disease or electrolyte imbalances should periodically check their heart rhythm via ECG. This drug may interact with several other medications; therefore, if any current medications are being taken, healthcare professionals should be informed. Special caution is needed if taken with medications that affect the heart, anticoagulants, antidepressants, immunosuppressants, analgesics, antibiotics, etc., as dose adjustment or monitoring may be required. Women who are pregnant or planning to become pregnant should not use this drug and should avoid pregnancy for one month after administration. Breastfeeding women should also avoid breastfeeding since this drug is excreted in breast milk. The safety of this drug for infants under 6 months has not been established, so it should be used cautiously only when absolutely necessary. Dizziness or seizures may occasionally occur while taking this drug, so caution is advised when driving or operating machinery. In case of overdose, hallucinations or unusual behavior may occur, so immediate medical attention is required, and gastric lavage or supportive treatment may be necessary. This drug is primarily excreted through urine, so adequate fluid intake and treatment to promote excretion may be helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocyte 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, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

This drug should be stored in a tightly closed container to avoid exposure to air or moisture. The best storage temperature is between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle