Megafluconazole Capsule (Fluconazole)

Adult dosage

The route of administration is determined according to the patient's clinical condition. Because absorption of the oral formulation is rapid and nearly complete, the doses of the oral formulations (capsules, dry syrup) and the injection are the same. Vaginal candidiasis: Administer a single 150 mg oral dose 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; local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., 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, 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. Depending on the patient's response, the dose may be increased to 400 mg once daily. 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 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 usually 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 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 once daily, depending on the patient's risk of fungal infection. 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, 400 mg once daily is recommended. In these patients, administer 400 mg starting 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 uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rate may vary by individual and age. Dermatophyte infections, 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, 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. Older adults: If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or increase the dosing interval. Patients with renal impairment: No dose adjustment is necessary for a single dose. If 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 on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, reduce the dose according to creatinine clearance.

Children's dosage

Adult dose 100 mg: Pediatric dose 3 mg/kg; do not exceed a maximum of 400 mg. Adult dose 200 mg: Pediatric dose 6 mg/kg; do not exceed a maximum of 400 mg. 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. Oropharyngeal candidiasis: Administer 6 mg/kg 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 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. 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 once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg 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. The duration of treatment is 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 initial treatment. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the same criteria as for adults with renal impairment. When administering doses below 10 mg, to ensure accurate dosing, administer the syrup orally or the injection intravenously, according to the child's clinical condition.

This medication should not be administered to specific patients. First, patients allergic to this medication or similar ingredients should not use it. Second, it should not be given to pregnant women or women with a possibility of pregnancy, as well as nursing mothers. Third, it should not be combined with certain medications due to the potential for serious side effects. Fourth, lactose intolerant patients or those with related genetic disorders should not take this medication. Additionally, caution should be exercised when using it in some patients. It should be used carefully in those with a history of drug allergies or issues with kidney or liver function, and in patients with heart disease or electrolyte disturbances. This medication can worsen liver function and poses a risk of cardiac rhythm disturbances, necessitating extra caution. It should be administered under the supervision of a physician in patients taking certain other medications. Generally, this medication is considered safe, but rare effects on the blood, liver, and kidneys may occur. Symptoms such as headache, gastrointestinal symptoms, skin reactions may appear, and severe skin rashes or liver function abnormalities may result, requiring immediate consultation with a healthcare professional. Pregnant women should avoid using it as it may pose a risk of teratogenic effects on the fetus. Nursing mothers should avoid it as it can be passed through breast milk. This medication can interact with many other drugs, so inform your doctor or pharmacist if you are taking other medications. Special care is needed when used with heart-related medications, anticoagulants, anticonvulsants, and immunosuppressants, which may require dose adjustments or monitoring. Use in children under 6 months should be limited to essential cases as safety has not been established. Caution is advised when driving or operating machinery as dizziness or seizures may occur as a result of taking this medication. In the case of overdose, symptoms of mental disturbances or behavioral changes may arise, and appropriate treatment should be sought immediately. Therefore, it is essential to consult healthcare professionals before taking this medication and to report any unusual symptoms immediately while on medication.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, 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, liver failure, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased sweating, drug eruption, 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, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

Store this medication in a tightly sealed container to prevent air or moisture ingress. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

A hard capsule with a green upper part and a yellowish lower part containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle