Flumax 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. Vulvovaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg of this medication once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral pain due to dentures): The usual dose is 50 mg of this medication once daily for 14 days, and local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose is 50 mg of this medication 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 of this medication 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 of this medication as a single dose on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment should be 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 medication 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 medication 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 have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg beginning 5-6 days before the expected 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, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and approximately 6-12 months for a toenail; growth rates may vary by individual and age. In some cases, the fingernails or toenails may remain damaged even after successful treatment with long-term administration. 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 medication once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks depending on the clinical 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), the dose should be reduced or the dosing interval extended. This medication is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose; however, when multiple doses are required, administer the usual dose on the first day only 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 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 days when dialysis is not performed, reduce the 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. The safety and efficacy of this medication have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of this medication 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 medication on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg 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 once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medication on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg 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 same criteria used for adults with renal impairment, based on the degree of renal impairment. For doses below 10 mg, 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. Patients with a history of hypersensitivity, pregnant women or those who may become pregnant, and nursing mothers should not take this medication. Additionally, caution should be exercised as serious side effects may occur when combined with certain medications. This medication contains lactose, and patients with lactose intolerance or related hereditary diseases should not take it. Patients with poor kidney or liver function should be particularly careful when using this medication, and caution is also needed for those with heart disease or electrolyte imbalances. When taking this medication alongside specific drugs, it is necessary for healthcare professionals to monitor it due to changes in blood concentrations or an increased risk of side effects. This medication is generally considered safe, but it can rarely affect the blood, liver, and kidneys, and side effects such as headaches, indigestion, or rashes may occur. Specifically, cardiac-related adverse reactions may occur; therefore, patients with heart disease should take caution. Regular blood tests, liver function tests, and kidney function tests are recommended during the course of taking this medication. There have also been reports of adrenal insufficiency, necessitating observation of this as well. This medication has numerous drug interactions, which may change drug concentrations or increase the risk of side effects when used in combination with others. Therefore, if you are taking other medications, be sure to inform your healthcare provider, and dosage adjustments or monitoring may be necessary for concomitant medications. This medication should be avoided during pregnancy, and women of childbearing potential should use effective contraception during and for some time after treatment. Nursing mothers are also advised against taking this medication. Safety in infants under 6 months of age has not been established; hence, it should only be used when absolutely necessary. This medication may cause dizziness or seizures when driving or operating machinery, so caution is advised. In case of overdose, hallucinations or abnormal behaviors may occur; in such situations, immediate medical attention should be sought. Supportive therapy and gastric lavage may be required in cases of overdose, and the drug can be removed through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, lightheadedness, Torsade 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, hepatocellular damage, rash, itching, hives, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, aggressive behavior

This medication should be stored in a tightly sealed container to prevent air entry, at a temperature between 1 to 30 degrees Celsius. Doing so helps maintain the effectiveness of the medication for a longer period.

Appearance

Hard capsule with upper part in sky blue and lower part in white filled with white crystalline powder

Package unit

24 capsules/bottle, 100 capsules/bottle