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 injectable formulations 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, 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 the clinical and mycological response, but treatment should generally continue 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, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to the patient's risk of developing a fungal infection. For patients at very high risk of systemic fungal infections, such as those undergoing bone marrow transplantation who have severe neutropenia or are expected to have 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 administering 400 mg 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 approximately 6-12 months; growth rates may vary by individual and age. In some cases, the fingernails or toenails may remain damaged 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 drug 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 infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults When 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 primarily in the urine unchanged. Dose adjustment is not 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 For patients receiving hemodialysis, 100% of the usual dose should be administered after each hemodialysis session. On days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Children's dosage

○ Pediatric patients 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. 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 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 recurrence. 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 treatment should be 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 recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all initial 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 administering 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 administered to certain patients. For example, it should not be used by individuals who are allergic to this drug or to azole medications. It should also not be given to pregnant women or women who may become pregnant, as well as to nursing mothers. There are certain medications that may pose risks when taken with this drug; therefore, it is crucial to inform your doctor about any current medications. When combined with medications that may affect the heart, it can lead to arrhythmias. Patients with genetic conditions like lactose intolerance should also avoid this medication. Patients with compromised kidney or liver function should use this medication cautiously, as there is a risk of further liver function decline. Patients with heart disease or electrolyte abnormalities should also be careful of arrhythmia risks when taking this drug. This medication has many potential interactions with other drugs, so caution is required when combined with such medications. In particular, careful dosage adjustment and monitoring should be conducted when taken alongside drugs that can affect the heart, anticoagulants, antidepressants, anticonvulsants, and immunosuppressants. This medication can affect liver and kidney function, so blood tests and liver function tests, as well as kidney function tests, are recommended before and during treatment. Taking this medication during pregnancy may harm the fetus, so strict contraception is necessary, and it should not be taken during pregnancy or lactation. For children, it should only be given in necessary cases since safety has not been established in infants under 6 months old. This medication may cause dizziness, drowsiness, or seizures, and caution is advised when driving or operating machinery. In case of overdose, psychiatric symptoms such as hallucinations or paranoia may appear; if suspected, seek medical attention immediately, and gastric lavage or supportive care may be required. This medication is primarily excreted through urine; hence, in cases of overdose, blood dialysis can reduce the 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, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatic cellular 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, asthenia, fever, adrenal insufficiency, hallucinations, aggressive behavior

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is important to store it at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance

Capsule filled with white powder, upper light blue, lower white.

Package unit

30 capsules/bottle, 100 capsules/bottle