Huni's Fluconazole Capsule

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single 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 concurrently. 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 by 200 mg once daily starting 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 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 by 200-400 mg once daily starting 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. 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 therapy. 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 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 patients with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. 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 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; 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. 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 of this drug once daily or 150 mg once weekly for 2-4 weeks. However, in the case of athlete's foot, treatment for 6 weeks may be necessary depending on the course of the infection. 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. If renal impairment is present (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 mainly in the urine in unchanged form. No dose adjustment is needed for a single dose. However, if multiple doses are required, administer the usual dose only on the first day of treatment, 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 Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should be given 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 patients Pediatric doses based on the adult dose 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, the safety and efficacy of this drug have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis Administer 6 mg/kg of body weight of this drug on the first day, followed by 3 mg/kg of body weight once daily starting the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis Administer 6 mg/kg of body weight of this drug on the first day, followed by 3 mg/kg of body weight once daily starting the next day. The dose may be increased to up to 12 mg/kg of body weight 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 of body weight once daily. The duration of treatment is determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis Administer 12 mg/kg of body weight of this drug on the first day, followed by 6 mg/kg of body weight once daily starting the next day. The dose may be increased to 12 mg/kg of body weight 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 of body weight once daily after the patient has completed all initial treatment. 6. 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, based on the degree of renal impairment. When administering doses of less than 10 mg, administer the syrup orally or inject the injection intravenously, according to the pediatric patient's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. For example, patients with allergies to this medication or similar drugs, women who are pregnant or breastfeeding, and patients taking certain other medications should not use this drug. Additionally, patients with renal or liver issues, cardiovascular diseases or at risk of arrhythmia, and those with a history of allergies should use this drug cautiously. This medication can affect liver function; thus, regular liver function tests are important during treatment. Blood tests and renal function tests may also be necessary. This drug can cause side effects related to heart rhythm, so patients with heart disease or electrolyte imbalances should be particularly careful. This medication may interact with several other drugs; therefore, if patients are taking other medications, they must inform healthcare providers, and careful observation and dosage adjustments may be needed when taken together. Women who are pregnant or may become pregnant should consult healthcare providers before taking this medication and must use effective contraceptive methods during treatment. Breastfeeding women are advised to avoid breastfeeding as this medication may be transmitted through breast milk. The safety for children, especially infants under 6 months of age, has not been established, so it should only be used cautiously when necessary. Care should be taken while driving or operating machinery as this medication may cause dizziness or seizures. If an overdose occurs, hallucinations or abnormal behavior may appear, and immediate contact with medical institutions is required, along with gastric lavage or supportive treatment if necessary. This medication is primarily eliminated through urine, so adequate hydration can be helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paraesthesia, dysgeusia, tremors, lightheadedness, 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, 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, malaise, asthenia, fever, adrenal insufficiency, hallucinations, altered behavior

Store this medication in a tightly closed container to protect it from air and moisture. The optimal storage temperature is between 1°C and 30°C.

Appearance

A hard capsule with a light blue top and white bottom filled with white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle