Fluconazole 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. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, 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. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400mg once on the first day, followed by 200mg once daily from the next day; depending on the patient's response, the dose may be increased to 400mg once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400mg once on the first day, followed by 200 ~ 400mg 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg once daily beginning 5-6 days before the expected onset of neutropenia and continue for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary by individual and age. After successful treatment with long-term therapy, fingernails or toenails may sometimes remain damaged. Dermatophytosis of the skin, 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 of the condition. For tinea versicolor, administer 50mg once daily for 2-4 weeks. Older adults with normal renal function should receive the usual adult dose. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: This medicine is excreted primarily in the urine unchanged. Dose adjustment is not necessary for a single dose. If 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) > 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 without dialysis, the dose should be reduced according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined according to the following guidelines and should 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. 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. 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. 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 according to clinical response and medical judgment. 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. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6mg/kg once daily after the patient has completed primary treatment. Children with renal impairment should have the dosing interval extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses of less than 10mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, patients allergic to this medication or similar classes of drugs, women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. Additionally, patients currently taking specific other medications should exercise caution as serious side effects may occur if this medication is combined with them. For example, it should not be used with medications that can affect cardiac rhythm, certain antibiotics, or antihistamines. This medication contains lactose; therefore, patients with a genetic disorder that prevents lactose digestion should not take it. Patients with renal or liver function issues, heart disease, or electrolyte imbalances should be especially cautious when using this medication and may need to adjust doses based on evaluations as necessary. While this medication is generally well tolerated, it can rarely cause abnormalities in blood, liver, or kidney function, as well as skin rashes or allergic reactions. Symptoms such as headache, indigestion, and nausea have also been reported, and any unusual symptoms should be immediately reported to healthcare personnel. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should use effective contraception during and for a period after taking this medication. It should only be used in young children, especially infants under 6 months of age, when absolutely necessary, as safety has not been established. During the course of treatment, caution should be exercised when driving or operating machinery as dizziness or seizures may occur. In the event of overdose, hallucinations or unusual behavior may occur; therefore, immediate medical attention is required, and, if necessary, this medication can be removed by blood dialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, pruritus, 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, combative behavior

This medication should be kept in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance

A hard capsule with a light blue upper part and white lower part filled with white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle