Difazole Capsules (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 orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral discomfort due to dentures): The usual dose is 50 mg of this medicine 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 medicine 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 medicine 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 depending on 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 is 400 mg of this medicine 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 usually continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on the patient's level 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 with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. In such patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, 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). 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 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 medicine 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. 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 extended. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dose adjustment is needed when administering a single dose. However, when 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) | 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 on 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 the adult dose are generally determined according to the following criteria and should not exceed 400 mg. Pediatric dose corresponding to an adult dose of 100 mg: 3 mg/kg Pediatric dose corresponding to an adult dose of 200 mg: 6 mg/kg Pediatric dose corresponding to an adult dose of 400 mg: 12 mg/kg However, safety and efficacy have not been established in infants younger than 6 months (see Precautions). 1. Oropharyngeal candidiasis Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. 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 once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis Administer 12 mg/kg of this medicine on the first day, followed by 6 mg/kg once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. 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 once daily after the patient has completed the initial treatment. 6. In pediatric patients 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 the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This drug should not be used in patients with specific allergic reactions or hypersensitivity to azole medications. It is safer not to administer this medication to women who are pregnant, may become pregnant, or are breastfeeding. It can cause serious side effects when taken with certain other medications, so it is essential to check for contraindicated drugs. Patients with lactose intolerance or specific genetic metabolic disorders should not take this drug. Caution is required for patients with kidney or liver dysfunction, as there is a risk of worsening liver function. Patients with heart disease or electrolyte imbalances should be given this drug carefully, as heart abnormalities such as arrhythmias may occur. This drug can inhibit multiple drug-metabolizing enzymes, increasing the blood concentrations of other medications, so consultation with a specialist regarding concomitant medications is necessary. Regular monitoring of liver function, kidney function, and blood tests is recommended during administration. Rarely, serious skin reactions or hepatotoxicity may occur, requiring immediate consultation with a doctor if unusual symptoms arise. Caution is also needed while driving or operating machinery due to the possibility of dizziness or seizures. In case of overdose, hallucinations or abnormal behaviors may occur and immediate treatment is needed. It is advised to avoid using this drug during pregnancy and to use contraception for a specified period after administration. If breastfeeding, it is recommended not to take this drug as it may be transferred to breast milk. Safety has not been established in infants under 6 months, and it should only be administered cautiously if absolutely necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, distension, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular injury, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

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

Appearance

An upper blue and lower white hard capsule filled with white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle