Candino Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral preparations are absorbed rapidly and almost completely, the doses of oral preparations (capsules, dry syrup) and injectable preparations 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 pain 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 infection, 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 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 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 response, but treatment should usually be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after the patient has completed all primary treatment, administer 200 mg of this drug once daily indefinitely. 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 risk of developing a 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 period of neutropenia, as in the case of bone marrow transplantation. In such patients, administer 400 mg beginning 5-6 days before neutropenia is expected to develop, 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; the growth rate may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. 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 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 should be administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval should be increased. ○ 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, if 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 undergoing 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 the adult dose generally follow the criteria below 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 in infants younger than 6 months have not been established. 1. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. Administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. 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 body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. Prevention of relapse of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed all initial treatment. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as for adults with renal impairment, based on the degree of renal impairment. When administering doses of less than 10 mg, administer the syrup orally or inject the solution intravenously, according to the child's clinical condition, to ensure accurate dosing.

This drug should not be used in certain patients. For example, it should not be administered to individuals with allergies to this drug or azole medications, pregnant women or women who may become pregnant, and nursing mothers. Additionally, caution is needed when using this drug with certain medications, as serious side effects may occur. In particular, it should not be combined with medications that may affect the heart or certain antibiotics and antiarrhythmics. This drug contains lactose, so it should not be given to patients with lactose intolerance or related genetic conditions. Patients with kidney or liver dysfunction should be more cautious when using this medication, and the risks of liver function deterioration or cardiac arrhythmia should be considered. Generally, this drug has fewer side effects, but occasionally may cause blood abnormalities, liver function abnormalities, skin rashes, gastrointestinal disturbances, and neurological anomalies. Therefore, if unusual symptoms occur, patients should consult a physician immediately. For patients with serious underlying conditions, it is important to regularly perform liver function tests and blood tests to check for abnormalities. This drug may interact with many medications, so patients taking other drugs should inform their healthcare providers, and dosage adjustments or monitoring may be necessary. Pregnant or nursing women should avoid using this drug, and women of childbearing age should use effective contraception during and for a certain period after taking this medication. In children, the safety of this medication has not been established for infants under 6 months of age, and should be used cautiously only in special cases. Caution is required while driving or operating machinery, as dizziness or seizures may occur. In case of overdose, hallucinations or unusual behaviors may appear, and immediate medical attention must be obtained. This drug is primarily excreted through urine, so adequate hydration and blood dialysis may be helpful if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT elevation, AST elevation, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular injury, 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, altered behavior

This medication should be stored in a tightly closed container to prevent air or moisture from entering. Additionally, it is best to store the drug at room temperature between 1°C and 30°C, not in excessively hot or cold areas.

Appearance

A hard capsule with a blue upper part and a white lower part containing a white powder

Package unit

30 capsules/bottle, 100 capsules/bottle