Dikazol Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since 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 soreness caused by dentures): The usual dose is 50 mg of this drug once daily for 14 days, and local disinfection of 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 from the next day; the dose may be increased to up 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 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 generally 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 treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to 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 infections, such as those undergoing bone marrow transplantation who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 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 6-12 months; growth rates may vary among individuals according to age. Even after successful treatment with long-term administration, fingernails or toenails may sometimes remain damaged. 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. ○ 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 increased. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. No dose adjustment is required for a single dose; however, when multiple doses are required, administer the usual dose only on the first day 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

○ Pediatric Pediatric doses based on the adult dose 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, 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 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine 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 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 body weight once daily. The duration of administration should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine 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 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 primary treatment. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as for adults with renal impairment, depending on the degree of renal impairment. When administering a dose of less than 10 mg, administer the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. First, individuals who have had allergic reactions to this medication or similar drugs should avoid taking it. Women who are pregnant, might become pregnant, or are breastfeeding should not use this medication. Additionally, serious side effects may occur if taken with specific medications, so it is crucial to consult a doctor or pharmacist if currently taking any medications. This medication contains lactose, so it is safer for those with lactose intolerance or related genetic disorders to avoid it. Patients with kidney or liver issues, heart diseases, or electrolyte imbalances should exercise special caution when using this medication. Regular monitoring of liver health should be conducted as liver function may deteriorate. Generally, this medication is well tolerated, but rarely side effects such as blood abnormalities, allergic reactions, liver dysfunction, cardiac arrhythmias, gastrointestinal disturbances, and skin rashes may occur. Particularly in cases of severe skin reactions or suspected liver dysfunction, consult medical staff immediately. During the intake of this medication, regular blood tests, liver and kidney function tests, and electrolyte tests should be performed, and if liver enzyme levels rise significantly, the decision to continue using the medication should be made cautiously. Additionally, electrocardiogram tests may be necessary to prevent cardiac-related side effects. This medication can interact with various drugs, so if other medications are being taken, it is essential to inform a healthcare professional. Particular monitoring or dosage adjustments may be required when used with drugs affecting the heart, anticoagulants, certain antidepressants, immunosuppressants, anticancer agents, analgesics, and antibiotics. Avoid use during pregnancy, and women who could become pregnant should employ effective contraception while taking this medication and for at least one month after discontinuation. Breastfeeding women are also advised not to take this medication. For infants under 6 months of age, safety and efficacy have not been sufficiently established, so it should be used cautiously only when necessary. Caution is necessary while taking this medication, as dizziness or seizures may occur while driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may appear, and immediate medical attention should be sought. This medication is primarily excreted through urine, so increasing fluid intake and, if necessary, assisting drug removal through dialysis may be helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory abnormality, taste abnormality, tremors, light-headedness, 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, hepatic necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased perspiration, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial swelling, alopecia, drug reaction accompanied by eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, agitated behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature to safely preserve the medication's efficacy.

Appearance

Capsule filled with white powder; the upper part is blue and the lower part is white.

Package unit

30 capsules/bottle, 100 capsules/bottle