Flucome 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 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 due to dentures): The usual dose is 50 mg of this drug 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 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; depending on the patient's response, the dose may be increased to 400 mg once daily. 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 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 drug once daily indefinitely after the patient has completed primary 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 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 expected to have prolonged neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg beginning 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 higher. 7. For onychomycosis, administer 150 mg once weekly. Continue treatment 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 rate 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 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 should 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 drug is excreted primarily in the urine unchanged. No dose adjustment is necessary when administering 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 next 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 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 Do not exceed a maximum of 400 mg. Safety and efficacy have not been established in infants under 6 months of age. 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. Treatment should continue 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. Depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. Administer for at least 3 weeks and for at least 2 weeks after symptoms have resolved. 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 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. Depending on the patient's response, the dose may be increased to 12 mg/kg body weight 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 body weight once daily after the patient has completed all initial treatment. 6. In children 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, use oral syrup or intravenous injection, depending on the child's clinical condition, to ensure an accurate dose.

This medication should not be used in certain patients. Patients who have had an allergic reaction to this medication or similar class of drugs should not take it. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication. Additionally, there are certain drugs that should not be used in conjunction with this medication as they may pose risks to the heart. Patients with lactose intolerance or certain genetic issues should also refrain from taking this medication. When using this medication, caution is particularly necessary for patients with compromised kidney or liver function, heart disease, or electrolyte abnormalities. Due to numerous drug interactions, if there are other medications being taken, it is essential to consult a doctor or pharmacist. This medication generally has few side effects, but in rare cases, it may affect blood or liver function and symptoms such as headache, abdominal pain, diarrhea, and nausea may occur. There is also a risk of heart rhythm disturbances, hence patients with heart disease should be cautious. Use of this medication should be avoided during pregnancy, and women of reproductive age should ensure effective contraception during and after discontinuation for some time. It is also advisable that breastfeeding mothers do not take this medication. In young children, especially those below 6 months, the safety has not been established, and it should only be used when absolutely necessary. Driving or operating machinery may cause dizziness or seizures due to this medication, so caution is needed. In the event of an overdose of this medication, hallucinations or abnormal behavior may occur, and immediate contact with a medical institution for appropriate treatment is necessary.

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 blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular injury, 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 (DRESS), myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, altered behavior

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is also advised to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

A capsule with the upper part blue and the lower part white, filled with white powder.

Package unit

30, 100 capsules/bottle