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. Vulvovaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this drug 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 of this drug is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose of this drug 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, urinary tract, etc.): The usual dose of this drug 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 according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug 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 the clinical and mycological responses, but treatment should generally continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer this drug at 200 mg 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 this drug at 50-400 mg 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 infections, such as those with severe neutropenia or an anticipated prolonged period of neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 7. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the fingernail or toenail has regrown (until a new, uninfected nail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary by age and from person to person. 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 of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks, depending on the course of the infection. 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 it is administered only once. 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, administer a reduced dose according to creatinine clearance.

Children's dosage

○ Children For children, doses based on the adult dose 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, the safety and efficacy in infants under 6 months of age have not been established (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 administration 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 children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses of less than 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 used in certain patients. For example, patients who are allergic to this drug or similar class medications, women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. Additionally, caution is needed for patients who are taking certain medications that may interact with this drug. It is especially important to avoid concomitant use with medications that may affect heart rhythm, certain antibiotics, and antihistamines. This drug contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with impaired kidney or liver function should be particularly cautious when using this medication, and caution is also necessary in cases of heart disease or electrolyte abnormalities. Regular monitoring of liver and kidney function, as well as blood tests, is necessary during treatment, since there is a risk of worsening liver function, and special attention should be given. Serious side effects can occur infrequently during treatment, so if symptoms such as headache, rash, indigestion, or elevated liver enzymes occur, medical consultation should be sought immediately. This medication may interact with several other medications, so if taking other drugs, it is necessary to inform and consult a physician or pharmacist. Pregnant or breastfeeding women should not take this drug, and women of childbearing potential must use effective contraception during the treatment and for one month after discontinuation of the treatment. This drug has not established safety in children, especially infants under 6 months of age, so it should only be used carefully when needed. Caution should be exercised when driving or operating machinery as this medication may cause dizziness or seizures. In cases of overdose, hallucinations or abnormal behavior may occur, so contact medical personnel immediately and receive appropriate treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocyte 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, psychotic behavior

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should maintain a room temperature between 1 degree and 30 degrees Celsius.

Appearance

A capsule with a blue upper part and a white lower part filled with white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle