Fluconazole Capsule 50mg (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. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 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, and mucocutaneous candidiasis, excluding vaginal 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, and urinary tract infections, etc.): The usual dose 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 according to the patient's response. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg 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 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 infection, such as those undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg beginning 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 higher. For onychomycosis, administer 150 mg once weekly 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 rates may vary by age and individual. Even after successful long-term treatment, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), ringworm of the body (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, 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. In patients with normal renal function, 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. This medicine is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose. When multiple doses are required, administer the usual dose on the first day only, 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 undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, administer a reduced dose according to creatinine clearance.

Children's dosage

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 400 mg. The safety and efficacy in infants under 6 months of age have not been established. 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 relapse. 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. 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, and urinary tract infections, etc.): Administer 6-12 mg/kg body weight once daily. The duration of treatment is determined by 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. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed primary treatment. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the severity of renal impairment, using the same criteria as for adults with renal impairment. When doses of less than 10 mg are required, administer the syrup orally or inject the injectable formulation intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This drug should not be used in certain patients. For example, patients who are allergic to this drug or similar drugs and women who are pregnant or breastfeeding should not take this medication. Additionally, patients taking certain drugs that have serious interactions with this medication should also avoid it. This drug contains lactose, so individuals with a genetic disorder of lactose intolerance should not take it. Patients with poor kidney or liver function, heart disease, or at risk for arrhythmias should use this drug cautiously. In particular, this drug may affect heart rhythms, so cardiac conditions should be closely monitored. Moreover, this drug significantly inhibits certain enzymes, which can alter the effects of other medications; hence, caution is warranted for concurrent medications. This drug is generally well tolerated, but rare side effects such as blood disorders, allergic reactions, liver function abnormalities, skin rashes, gastrointestinal disturbances, headaches, dizziness, etc., may occur. Severe liver damage or arrhythmias have been reported rarely, so any unusual symptoms should prompt immediate consultation with a physician. It is advisable to have regular blood tests and liver and kidney function tests during the course of this treatment. Pregnant women should avoid taking this medication as it may harm the fetus, and women of childbearing potential should practice contraception during and for one month after treatment. Nursing mothers should also avoid taking this drug for safety. This drug may cause dizziness or seizures when driving or operating machinery, so caution is required. In case of overdose, hallucinations or abnormal behaviors may occur, and immediate medical attention should be sought. This drug is primarily excreted in urine, so adequate hydration and, if necessary, hemodialysis may be helpful.

Thrombocytopenia, leukopenia, neutropenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory abnormalities, taste disturbances, tremors, 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, hepatocyte necrosis, hepatitis, hepatocyte 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This drug should be stored in a tightly sealed container to protect it from air and moisture, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle