Entifunal Capsule 50 mg (Fluconazole)

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 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 pain 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, 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 based on 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 relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all primary treatment. 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 degree of 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg starting 5-6 days before the onset of neutropenia is expected, 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 fingernails or toenails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary between individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. 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, 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. ○ 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 extended. ○ Patients with renal impairment This drug is excreted primarily 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 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 general guidelines are used for pediatric doses based on the adult dose, and the dose 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 medicine have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer this medicine at 6 mg/kg body weight on the first day, then 3 mg/kg body weight once daily from the following day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer this medicine at 6 mg/kg body weight on the first day, then 3 mg/kg body weight once daily from the following day. The dose may be increased to 12 mg/kg 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, and urinary tract infections, etc.): Administer 6-12 mg/kg body weight once daily. The duration of administration should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer this medicine at 12 mg/kg body weight on the first day, then 6 mg/kg body weight once daily from the following day. The dose may be increased to 12 mg/kg 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 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 an accurate dose.

This medication should not be used by certain patients. For example, individuals who are allergic to this medication or other azole drugs, pregnant or breastfeeding women, and patients taking certain other medications should avoid this drug. Additionally, patients with kidney or liver function problems or heart diseases need special caution when using this medication. This medication can affect heart rhythm, thus patients with a risk of arrhythmia should be particularly cautious. Although this drug is generally well tolerated, it can rarely cause abnormalities in blood, liver, or kidney function, as well as side effects like skin rashes, headaches, and digestive disorders. Therefore, if any unusual symptoms occur, patients should consult a healthcare professional immediately. Patients taking this medication are advised to have regular blood tests and liver and kidney function tests. Especially, patients with severe conditions need more thorough monitoring. This medication can interact with several other drugs, so it is essential to inform healthcare professionals about any other medications being taken. Taking it with some medications may increase the risk of side effects or alter the drug's efficacy. Women who are pregnant or planning to conceive should consult a doctor before taking this medication and need effective contraception during the treatment and for at least one month after stopping the drug. Breastfeeding women are also advised not to take this medication. The safety of this medication has not been established in infants under 6 months old, so it should only be used when absolutely necessary. Patients should be cautious as this medication may cause dizziness or seizures while driving or operating machinery. Lastly, overdose may lead to psychiatric symptoms, so correct dosage must be taken as directed by a healthcare provider, and in case of overdose, contact a medical institution immediately for appropriate treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, necrosis of liver cells, hepatitis, liver cell injury, 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, weakness, fever, adrenal insufficiency, hallucinations, altered behavior

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to keep the storage temperature between 1 degree and 30 degrees Celsius to ensure the efficacy and safety of the drug.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle