Candizole Capsule (Fluconazole)

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 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 vaginal 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 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 should be 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 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 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 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 infections, such as those undergoing bone marrow transplantation, or those expected to have severe neutropenia or prolonged neutropenia. In these patients, 400 mg should be administered starting 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 above. 7. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly. Continue treatment until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails 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. 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, 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. ○ Elderly patients If renal function is normal, the usual adult dose may 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 in unchanged form. Dose adjustment is not 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 In 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 The following criteria are generally used to determine pediatric doses based on the adult dose; do not exceed a maximum of 400 mg. Adult dose 100 mg: Pediatric dose 3 mg/kg, maximum 400 mg Adult dose 200 mg: Pediatric dose 6 mg/kg, maximum 400 mg Adult dose 400 mg: Pediatric dose 12 mg/kg, maximum 400 mg However, safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day, up to a maximum of 400 mg. Treatment should be continued for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/kg of body weight once daily according to the patient's response, up to a maximum of 400 mg. 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.): 6-12 mg/kg of body weight once daily, up to a maximum of 400 mg. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, then 6 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/kg of body weight once daily according to the patient's response, up to a maximum of 400 mg. Treatment should be continued 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 all initial treatment. 6. In pediatric patients with renal impairment, depending on the degree of renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses below 10 mg, administer the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be used by certain patients. First, individuals allergic to this drug or similar substances should avoid taking it. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not use this medication. Additionally, concurrent use with certain drugs can cause serious side effects, so it should not be combined with them. For example, taking it with drugs affecting the heart or certain antibiotics and antihistamines can be dangerous. This medication contains lactose, making it unsuitable for those with lactose intolerance or related genetic disorders. Patients requiring caution when using this medication also exist. Patients with a history of drug allergies or problems with kidney or liver function should carefully evaluate before use. Those with heart disease or electrolyte imbalances should pay particular attention due to the risk of cardiac issues such as arrhythmias. This drug inhibits certain enzymes in the liver and can interact with various medications, so patients taking other medications should consult their doctor or pharmacist. The medication is generally well tolerated, but may rarely affect blood, liver, or kidney function and can cause skin rashes or gastrointestinal symptoms. If severe skin reactions or liver function abnormalities occur, medical personnel should be informed immediately. It is especially important not to use this medication during pregnancy. High doses during early pregnancy may increase the risk of congenital anomalies in the fetus, so women of childbearing age should ensure effective contraception during and for at least one month after taking this medication. Breastfeeding women should also avoid it as it can transfer into breast milk. Safety for children, especially infants under 6 months, has not been thoroughly established, so it should only be used when essential. When taking this medication, caution is required when driving or operating machinery, as dizziness or seizures may occur. If this medication is taken in excess, hallucinations or unusual behavior may occur, and immediate medical treatment is necessary. This medication is primarily eliminated 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, sensory disturbances, taste disturbances, tremors, vertigo, Torsade 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, hepatocellular necrosis, hepatitis, hepatocellular damage, 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, behavioral disturbances

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. This will help to preserve the effectiveness of the medication for a longer period.

Appearance

Capsules filled with white powder upper - blue, lower - white.

Package unit

30 capsules/bottle, 100 capsules/bottle