Fluconazole Capsules

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 product 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 product 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 product 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 product 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 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 product 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 usually continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this product 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 product once daily, depending on the patient's risk of developing a fungal infection. For patients at very high risk of systemic fungal infection, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation, 400 mg once daily is recommended. In these patients, 400 mg should be administered beginning 5-6 days before neutropenia is expected to develop and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary among individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For skin 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 product 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 disease. 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 product 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 and adjust the dose from the following 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 as follows; 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 The safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg on the first day, followed by 3 mg/kg once daily from the next day. Treatment should be given for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg 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 once daily. The duration of treatment is determined by clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to 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 once daily after the patient has completed the initial course of treatment. 6. Children with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as for adults with renal impairment. When administering doses below 10 mg, use oral syrup or intravenous injection, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. For example, patients who have had hypersensitivity reactions to this drug or other azole medications, women who are pregnant or may become pregnant, and nursing mothers should not use this medication. In addition, serious side effects can occur when taken with certain medications, so co-administration should be avoided. For example, taking it with terfenadine, cisapride, astemizole, or erythromycin may increase the risk of heart rhythm abnormalities. This medication contains lactose and should not be administered to patients with lactose intolerance or related hereditary diseases. Patients with kidney or liver function issues should use this medication cautiously, and regular testing is necessary as liver function may worsen. Patients with heart diseases or electrolyte abnormalities should be cautious as arrhythmias may occur during the use of this medication. This drug inhibits several drug-metabolizing enzymes, so careful monitoring and dosage adjustments are required when co-administered with other medications. This medication generally has good tolerability, but rare side effects such as blood abnormalities, liver function abnormalities, skin rashes, and neurological abnormalities may occur. In particular, patients with severe underlying diseases should have the administration of this drug reevaluated if liver enzyme levels increase. It is safest to avoid using this medication during pregnancy, and effective contraception should be implemented for about a month after the administration period and last dose. Nursing mothers are also advised not to take this medication. The safety of this medication for infants under 6 months old has not been established, so it should only be administered cautiously if necessary. Driving or operating machinery should be approached with caution as dizziness or seizures may occur due to taking this medication. In case of overdose, hallucinations or abnormal behaviors may occur, and appropriate treatment and supportive therapy will be needed. Blood dialysis can reduce the concentration of this drug in the body.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, elevated ALT, elevated AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular 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, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a sealed container to protect it from air and moisture. It is also best to store the medication at room temperature between 1 and 30 degrees Celsius.

Appearance

Capsule with a blue upper part and a white lower part containing white to pale yellow powder

Package unit

30 capsules/bottle, 100 capsules/bottle