Fluconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Absorption of oral formulations is rapid and almost complete; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg 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 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 vulvovaginal candidiasis): The usual dose is 50 mg 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 400 mg as a single dose 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed the full course of primary treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of 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. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the nails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary between individuals and with age. In some cases, nails may remain damaged even after successful treatment with long-term administration. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may be needed for 6 weeks depending on its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. This drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose; 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 Hemodialysis patients: 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days without dialysis, administer a reduced dose according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. 100 mg: 3 mg/kg 200 mg: 6 mg/kg 400 mg: 12 mg/kg Safety and efficacy have not been established in infants younger than 6 months. Oropharyngeal candidiasis: Administer 6 mg/kg body weight 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. Esophageal candidiasis: Administer 6 mg/kg body weight 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. Continue treatment 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 body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg body weight 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed the full course of primary treatment. 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 doses below 10 mg, administer the syrup orally or inject the injectable formulation intravenously according to the child's clinical condition to ensure accurate dosing.

This medication should not be used in certain patients. Patients who are allergic to this medication or similar drugs, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Additionally, serious side effects may occur when taken with certain medications, so patients must inform their doctor or pharmacist of any currently used medications. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Caution is especially needed in patients with kidney or liver dysfunction, as well as those with heart conditions or at risk of arrhythmias. Patients with a history of drug hypersensitivity should use it cautiously, and dose adjustments and monitoring are necessary when used in conjunction with certain medications. Generally, this medication is well tolerated, but it can, in rare cases, affect blood, liver, or kidney function, and skin rashes or allergic reactions may occur. Gastrointestinal symptoms such as headaches, abdominal pain, diarrhea, and nausea are also commonly reported. Serious side effects such as significant liver damage or cardiac arrhythmias can occur rarely, so patients should consult medical personnel immediately if unusual symptoms arise. Patients with severe underlying conditions should regularly undergo tests for blood, liver, and kidney functions during the use of this medication. There is a particular risk of rapid liver function deterioration; if liver enzyme levels rise significantly, the risks and benefits of continued use must be carefully evaluated. Additionally, patients with decreased kidney function should perform kidney function tests before administration and adjust the dosage. This medication can cause changes in cardiac electrical signals, increasing the risk of arrhythmias; therefore, patients with heart disease or electrolyte imbalances should be cautious. Furthermore, resistance may develop in certain species of Candida, necessitating alternative antifungal treatment in case of treatment failure. This medication has numerous drug interactions, so other medications should be disclosed to healthcare providers. Pregnant women should avoid taking this medication, and women of childbearing age should use effective contraception during and for one month after treatment. Nursing mothers are also advised not to take this medication. Safety in infants under six months of age has not been established, so it should only be administered cautiously when necessary. Dizziness or seizures can occasionally occur while taking this medication, so caution is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may appear, necessitating immediate medical attention. This medication is primarily excreted through urine, so treatments that increase urine output or hemodialysis may help in cases of overdose.

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, increased ALT, increased AST, increased alkaline phosphatase in the blood, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic 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 swelling, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, atypical behavior

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance

Hard capsule with a blue upper part and a white lower part filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle