Diflucan 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 of this drug is 50 mg once daily for 7-14 days, and treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral discomfort due to dentures): The usual dose of this drug is 50 mg once daily for 14 days; local disinfection of the dentures should also be performed. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this drug 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 of this drug 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed from the next day by 200-400 mg once daily. The duration of treatment is determined by the clinical and mycological response, but treatment should usually be given 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 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 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 those undergoing bone marrow transplantation, or those expected to have severe or prolonged 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 higher. 7. For onychomycosis, administer 150 mg once weekly, and continue treatment until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). New fingernails usually take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For fungal infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug 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 the course of the condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients 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 should be extended. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. No dose adjustment is necessary when it is administered as 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 Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed a maximum of 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 younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this drug on the first day, followed by 3 mg/kg body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this drug on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily depending on the patient's response. Treat 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 body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this drug on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily depending on the patient's response. Treatment should continue 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 primary treatment. 6. Children with renal impairment should have their dosing interval increased and dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. When administering doses of less than 10 mg, syrup should be given orally or the injection administered intravenously, depending on the child's clinical condition, to ensure an accurate dose.

This medication should not be used in certain patients. For example, patients who have had an allergy to this medication or its ingredients, or women who are pregnant or breastfeeding should not take it. Additionally, serious side effects may occur when taken with certain other medications, so it should not be co-administered. This medication contains lactose and is not suitable for patients with lactose intolerance or related genetic disorders. Patients with poor kidney or liver function, or those at risk of arrhythmia due to heart disease or electrolyte imbalances should use this medication with caution. Since this medication can affect liver function, it is important to regularly undergo liver function tests. This medication can interact with several other drugs, so patients should strictly follow the doctor's instructions, especially when taking drugs that affect the heart or drugs that are metabolized by the liver. It should not be used during pregnancy, and women of childbearing potential should use effective contraception during and for some time after taking this medication. It is also safer for breastfeeding women not to take this medication. In children, especially infants under 6 months of age, the safety of this medication has not been established, so it should only be administered with caution when necessary. During treatment with this medication, dizziness or seizures may occasionally occur, necessitating caution when driving or operating machinery. In cases of overdose, hallucinations or abnormal behavior may appear, so patients should contact medical institutions immediately and receive appropriate treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, lightheadedness, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, elevated ALT, elevated AST, increased serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocellular 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, bizarre behavior

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It should be stored at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

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