Fluconazole Capsule 50 mg

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 injections are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg of this drug once daily for 14 days, together with local disinfection of the dentures. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this drug 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, urinary tract, etc.): The usual dose is 400 mg of this drug 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 depending on the patient's response. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug 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 be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily, depending on the patient's degree of risk for 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 duration of neutropenia, as in the case of bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before the anticipated 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 new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary from person to person depending on age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this drug once daily or 150 mg once weekly for 2-4 weeks. However, in the case of athlete's foot, treatment for 6 weeks may be necessary depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. In the presence of 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 primarily in the urine unchanged. No dose adjustment is necessary when administering a single dose. However, when multiple doses are required, administer the usual dose only on the first day of treatment 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 criteria 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 The safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis Administer this medicine at 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis Administer this medicine at 6 mg/kg of body weight 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. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.) Administer a dose of 6-12 mg/kg of body weight once daily. The duration of treatment should be determined based on clinical response and medical judgment. 4. Cryptococcal meningitis Administer this medicine at 12 mg/kg of body weight 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. 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 full course of primary treatment. 6. Pediatric patients with renal impairment should have their dosing intervals extended and doses reduced according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering a dose of less than 10 mg, syrup should be given orally or the injection administered intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to specific patients. For instance, patients who have previously shown allergic reactions to this medication or similar azole class drugs, pregnant women or women who may become pregnant, and breastfeeding women should not use this drug. Additionally, patients taking certain medications alongside this drug should avoid its use. Particularly, combinations with terfenadine, cisapride, astemizole, erythromycin, quinidine, and ergotamine can lead to dangerous cardiac side effects. This medication contains lactose, and patients with lactose intolerance or related genetic disorders should not use it. Patients with kidney or liver dysfunction, those with heart disease or electrolyte imbalances that pose a risk for arrhythmias should use this medication cautiously, and those with a history of drug hypersensitivity should also exercise caution. This medication may affect liver and kidney function, so it is advisable to conduct blood tests and liver and kidney function tests before and during administration. This drug can influence heart rhythms and may particularly induce QT interval prolongation, hence caution is warranted in patients with heart conditions. Given its potential to interact with various medications, it is crucial to inform healthcare providers of any other medications being taken, and medication dosage adjustments or monitoring may be required as needed. It is recommended that pregnant or breastfeeding women do not use this medication; fertile women should ensure effective contraception during and for a certain period after using this drug. In children, particularly infants under 6 months, safety and efficacy have not been sufficiently established, so it should only be carefully administered in necessary cases. Due to the potential for dizziness or seizures, caution is also advised when driving or operating machinery. In the case of an overdose, hallucinations or abnormal behaviors may occur, requiring immediate medical assistance, and supportive treatment or gastric lavage may be necessary if needed. This drug is mostly excreted through urine, so in cases of overdose, blood dialysis can help reduce drug concentration.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication for a longer period.

Appearance

Capsule with upper part in blue and lower part in white filled with white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle