Hyutex Fluconazole Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. As oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 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. Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg of this drug once daily for 14 days; local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, and urinary tract infections, etc.): The usual dose is 400 mg once on the first day, followed from the next day by 200 mg once daily. 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 is 400 mg once on the first day, followed from the next day by 200-400 mg once daily. The duration of treatment should be determined according to clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 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 entire course of primary treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to 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 infection, such as those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg once daily starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg once daily for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary by individual and age. In some cases, the nails may remain damaged after successful treatment with long-term administration. Dermatophyte 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. For patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This drug is excreted mainly in the urine unchanged. No dose adjustment is necessary when administering a single dose. 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 Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, reduce the dose according to creatinine clearance.

Children's dosage

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 Do not exceed 400 mg. The safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of this drug on the first day, followed from the next day by 3 mg/kg once daily. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this drug on the first day, followed from the next day by 3 mg/kg once daily. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treat 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.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this drug on the first day, followed from the next day by 6 mg/kg once daily. The dose may be increased to 12 mg/kg once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed the entire course of primary treatment. 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, based on the degree of renal impairment. When administering doses below 10 mg, administer the oral syrup or give the injection intravenously according to the child's clinical condition to ensure accurate dosing.

This medication should not be administered to certain patients. Firstly, patients with allergic reactions to this medication or similar drugs should not use it. Pregnant women or those who may become pregnant, as well as nursing mothers, should not take this drug. Additionally, serious side effects may occur when taken together with certain medications; thus, concomitant use should be avoided. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should also refrain from its use. Patients with kidney or liver problems, heart disease, or electrolyte imbalances should use this drug cautiously. Specifically, patients at risk for cardiac arrhythmias should closely monitor their cardiac condition while taking this medication. This medication strongly inhibits certain enzymes; therefore, dose adjustment and monitoring are necessary when used with other medications metabolized by those enzymes. This drug is generally well tolerated, but rare side effects may affect blood, liver, and kidney function, necessitating regular testing. Moreover, side effects such as headache, abdominal pain, diarrhea, and rashes may occur, so if symptoms are severe, medical consultation is advised. Pregnant women should avoid taking this medication as it can affect the fetus, and use effective contraception while on this medication. Nursing mothers should avoid this medication as it is transferred to breast milk. Safety has not been established for infants under 6 months; administration should only be considered in special cases. Caution is advised while driving or operating machinery, as this medication may cause dizziness or seizures. In case of overdose, hallucinations or abnormal behavior may occur; if suspected, seek medical attention immediately for appropriate treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, 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, liver cell injury, 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, aggressive behavior

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is safely stored at cool room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle