Daewoo 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. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single 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 caused by dentures): The usual dose is 50 mg of this drug 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, 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 once 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug 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 given 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 of developing a fungal infection. For patients at very high risk of systemic fungal infections, 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 onset of neutropenia is expected and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 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 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. Fungal infections of the skin, including tinea pedis, tinea corporis, 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, 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 is 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. 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 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 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 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 400 mg. Infants under 6 months: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: Administer 6 mg/kg of this medicine 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. 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 once daily. The duration of administration is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of this medicine 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. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed initial treatment. 6. 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. For doses below 10 mg, administer the oral syrup or give the injection intravenously, as appropriate to the child's clinical condition, to ensure accurate dosing.

This medicine should not be administered to certain patients. For example, patients who have had an allergic reaction to this drug or other azole agents, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Additionally, it may be dangerous to take this medicine with certain other drugs, so patients taking medications such as terfenadine, cisapride, astemizole, erythromycin, pimozide, quinidine, or ergotamine should not use this drug. This medication contains lactose; patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Patients who require caution during administration include those with a history of drug allergies, impaired kidney or liver function, or those at risk of arrhythmias due to heart disease or electrolyte imbalances. This drug may affect liver function, so patients with poor liver function require more careful monitoring. Additionally, this drug can interact with multiple other medications, so anyone taking other drugs must inform their doctor or pharmacist, and adjustments in drug dosage or monitoring may be necessary. During treatment with this drug, side effects such as headache, abdominal pain, diarrhea, nausea, and rash can occur. Rarely, serious side effects such as significant liver damage or blood abnormalities, as well as heart rhythm abnormalities, may also occur. If any unusual symptoms develop, immediate consultation with a healthcare professional is required. Pregnant women should avoid taking this drug due to the potential risk of harm to the fetus, and women of childbearing age should practice effective contraception during and for one month after treatment. Nursing mothers should also avoid this drug as it is excreted in breast milk, requiring them to either stop breastfeeding or avoid taking this medication. The safety of this drug in infants less than 6 months old has not been established but should be used cautiously only if necessary. Caution is advised if driving or operating machinery, as this drug may cause dizziness or seizures. In case of overdose, hallucinations or unusual behavior may occur, requiring immediate hospital visit for appropriate treatment. Blood dialysis may also be attempted to remove the drug if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, 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, elevated bilirubin, hepatotoxicity, liver 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, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This drug should be stored in a tightly sealed container that is well-ventilated and kept at room temperature between 1 to 30 degrees Celsius. This helps maintain the drug's effectiveness over time.

Appearance

A hard capsule with a blue upper body and white lower body containing white to off-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle