Fluconazole Capsule 50 mg

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, powder for oral suspension) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concomitantly. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, 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. 3. 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. 4. 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 generally be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after completion of the initial treatment, administer 200 mg once daily indefinitely. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg 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 or expected prolonged neutropenia, as in bone marrow transplantation. In these patients, 400 mg should be administered 5-6 days before the expected onset of neutropenia and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. 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; the growth rate may vary by individual and age. In some cases, the nails may remain damaged after successful treatment with long-term administration. For fungal skin infections, including tinea pedis, tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, tinea pedis may require treatment for 6 weeks, depending on its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should be administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. Dose adjustment is not necessary for a single dose. However, 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 Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on adult doses are generally determined according to the following guidelines and should not exceed 400 mg. 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 However, safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. 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 starting the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 2. 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 starting the next day. The dose may be increased to 12 mg/kg of body weight once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. 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 is determined according to the clinical response and medical judgment. 4. 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 starting the next day. The dose may be increased to 12 mg/kg of body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg of body weight once daily after the patient has completed the entire course of primary treatment. 6. In pediatric patients 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 doses of less than 10 mg are administered, use the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. Those who have had allergic reactions to this drug or similar medications should not use it. It should not be taken by pregnant women or those who may become pregnant, and by breastfeeding individuals. Additionally, caution is advised when taking this medication with specific heart-related drugs or certain other medications, as it may pose risks. This medication contains lactose, so individuals with genetic issues such as lactose intolerance should also refrain from using it. This medication should be used with caution in individuals with renal or hepatic dysfunction, as well as those with heart disease or electrolyte abnormalities. Particularly, those who may have cardiac rhythm issues should have their heart health closely monitored while taking this medication. Furthermore, since this medication inhibits enzymes involved in drug metabolism in the liver, there is a need for caution when taken with other drugs, as it may increase drug concentrations and the risk of side effects. This medication is generally well tolerated, but rare instances of blood abnormalities, liver dysfunction, skin rashes, gastrointestinal disturbances, and neurological symptoms may occur. It is particularly important to routinely monitor liver function during treatment as this medication can worsen liver function. Immediate consultation with a healthcare provider is necessary if any skin abnormalities occur. While taking this medication, it is advisable to undergo periodic testing for blood, liver, and renal function. Patients with severe illnesses should be closely monitored. Patients with poor renal function should conduct renal function testing before use and may require dosage adjustments. This medication may cause adrenal insufficiency, so symptoms associated with this should also be carefully observed. There are many drug interactions with this medication, necessitating dosage adjustments or monitoring based on other concomitant medications. Particular caution should be exercised when using it along with drugs affecting the heart, anticoagulants, certain antidepressants, immunosuppressants, and chemotherapeutic agents. Patients must inform their physician or pharmacist of all medications they are currently taking. Usage of this medication should be avoided during pregnancy, and women planning to become pregnant should adopt effective contraceptive measures during and for one month after taking this medication. Nursing women should also avoid taking this medication as it can be excreted in breast milk. Safety and efficacy have not been established in infants less than 6 months old, so it should be used cautiously only in necessary cases. Dizziness or seizures may occasionally occur when taking this medication, so caution is needed while driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors could manifest, requiring immediate contact with a healthcare facility for appropriate treatment. Gastric lavage or supportive care may be needed, and the drug concentration in the body may be reduced through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, lightheadedness, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatic necrosis, hepatitis, hepatocellular injury, 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, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1°C and 30°C to ensure the safety of the drug's effectiveness.

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