Fluconazole Capsule

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 a single oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg 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 infections, 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 400 mg of this medicine 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine 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 of this medicine once daily indefinitely after the patient has completed initial 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, depending on 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 with severe neutropenia or an expected prolonged period of neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg beginning 5-6 days before neutropenia is expected to start, and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 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. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, 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 infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. When renal function is normal, the usual adult dose may be 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 unchanged in the urine. No dosage adjustment is necessary for a single dose. If 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 on 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

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 younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of 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 of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Administer 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 of body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of body weight of this medicine on the first day, followed by 6 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. 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 of body weight once daily after the patient has completed initial 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 a dose of less than 10 mg, administer the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure an accurate dose.

This medication should not be administered to certain patients. For instance, patients with an allergy to this drug or similar medications, pregnant women or women who may become pregnant, and breastfeeding women should avoid use. Additionally, patients taking this medication with certain other drugs should be restricted or monitored closely. Particularly, concurrent use with drugs that may affect the heart can be risky, so caution is advised. This medication contains lactose, so it should not be used by patients with genetic metabolic disorders such as lactose intolerance. Patients with impaired kidney or liver function, or those with heart disease or electrolyte disturbances should use this medication with extra caution and, if necessary, under strict medical supervision. During treatment with this medication, side effects such as headache, abdominal pain, diarrhea, liver function abnormalities, and skin rashes may occur, so if symptoms are severe or persistent, consultation with healthcare professionals is advised. Especially if liver function abnormalities are suspected, the administration of this medication may need to be stopped or adjusted, and patients with severe underlying conditions should undergo regular blood and liver function tests. This medication can interact with various drugs; therefore, if other medications are being taken, patients must inform healthcare professionals and be closely monitored. Pregnant women or those planning to become pregnant must discuss the use of this medication with a physician beforehand, and effective contraception should be used during the treatment period and for some time afterward. Breastfeeding women should avoid use as this medication is excreted in breast milk. The safety of this medication in infants under 6 months of age has not been established; it should be used only when absolutely necessary, and under a specialist’s guidance. During treatment with this medication, caution is needed due to the potential for dizziness or seizures while driving or operating machinery. In cases of overdose, hallucinations or abnormal behaviors may occur; medical help should be sought immediately for appropriate treatment. This drug is primarily excreted in urine, so adequate fluid intake and, if needed, hemodialysis may be beneficial.

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, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular 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 medication should be stored in a tightly closed container to protect it from light and air, maintaining a storage temperature between 1 to 30 degrees Celsius. Thus, avoid storing in excessively hot or cold environments, and it is advisable to keep it in a cool, dry place.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle