Danakan Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this drug is 50 mg 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 of this drug is 50 mg 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 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 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 the 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 by 200-400 mg once daily from the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should generally be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer this drug at a dose of 200 mg 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 this drug at a dose of 50-400 mg once daily, depending on the patient's 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 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 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). Fingernails usually take 3-6 months to regrow, and toenails take about 6-12 months; growth rates may vary by age and from person to person. In some cases, the nails may remain damaged after successful treatment with long-term administration. For fungal skin infections, 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 infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should 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 needed when a single dose is administered; 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 ≤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 be given 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

The following criteria are generally used to determine pediatric doses based on the adult dose; do 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 in infants under 6 months of age have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis Administer 6 mg/kg of this medicine on the first day, then 3 mg/kg once daily from the following day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis Administer 6 mg/kg of this medicine on the first day, then 3 mg/kg once daily from the following day. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. 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 a dose of 6-12 mg/kg once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis Administer 12 mg/kg of this medicine on the first day, then 6 mg/kg once daily from the following 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 all primary treatment. 6. For children 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 doses of less than 10 mg are administered, use oral syrup or administer the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used by individuals with certain allergic reactions. Particularly, those who have had an allergic reaction to this drug or similar drugs should not take it. Pregnant women or those who may become pregnant, as well as nursing mothers, should not take this medication due to the potential risks to the fetus or infant. Also, taking this medication in conjunction with certain other drugs may cause serious side effects, so it should not be taken together. For example, it may be dangerous when combined with drugs that affect heart rhythm. Patients with lactose intolerance or certain genetic metabolic disorders should also avoid using this medication. Patients with weakened kidney or liver function should be cautious when taking this medication, as it may pose a risk of liver function deterioration. Individuals with heart conditions or electrolyte imbalances should also be careful, as there is a possibility of arrhythmias and other heart issues when taking this medication. It is advisable to regularly check liver and kidney functions, and blood status to ensure safety. This medication has many drug interactions, so consultations with a doctor or pharmacist are essential when taking it with other medications. Caution is particularly needed when combined with heart-affecting drugs, anticoagulants, antidepressants, and anticonvulsants. When driving or operating machinery, caution is advised because this medication may cause dizziness or drowsiness after ingestion. In case of overdose, hallucinations or abnormal behavior may occur, so dosage should be followed, and immediate consultation with medical institutions is necessary in case of overdose. Special caution is needed for children and infants, and it should only be used in infants under 6 months of age when absolutely necessary, as its safety has not been established in this age group.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, 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, hepatic failure, hepatic cell 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, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly sealed container to prevent exposure to air or humidity. Additionally, it should be kept at room temperature, ideally between 1 and 30 degrees Celsius.

Appearance

[Domestic, Export] Hard capsules with green (upper part) and white (lower part)

Package unit

[Domestic]: 30 capsules/bottle, 100 capsules/bottle, [Export]: 10 capsules*3PTP/case