Candinol Capsule 50 mg (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 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 infection, 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 as a single dose on the first day, followed by 200 mg once daily starting the next day. The dose may be increased to 400 mg once daily depending on the patient's response. The duration of administration should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug as a single dose on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment is determined by the clinical and mycological responses, but treatment should usually be continued 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 infection 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 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 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 higher. 7. For onychomycosis, administer 150 mg once a week 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 among individuals and with age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections of the skin, 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 a week for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks depending on the clinical 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. If renal impairment is present (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. Dose adjustment is not required 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 following day as follows. Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not receiving 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 The pediatric dose based on the adult dose is 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 younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg per kg of body weight 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 per kg of body weight once daily. The duration of administration should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg per kg of body weight of this medicine on the first day, followed by 6 mg per kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg per kg of body weight 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 per kg of body weight 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 as for adults with renal impairment, depending on the degree of renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously according to the child's clinical condition to ensure an accurate dose.

This medication should not be used in certain patients. Patients who are allergic to this drug or similar drugs, pregnant women, or nursing mothers should avoid taking this medication. Additionally, caution is required for patients who are taking certain medications that may cause heart problems. Patients with genetic issues such as lactose intolerance should also avoid this medication. This drug should be used cautiously in patients with a history of allergic reactions, poor kidney or liver function, or risk of heart disease. Patients taking other specific medications require careful monitoring by a physician. Since this drug can affect liver and kidney function, blood tests and liver and kidney function tests are recommended before administration. While this drug is generally safe, it can rarely cause adverse reactions in the blood, liver, kidneys, skin, and other areas. If a skin rash or liver function abnormalities occur, consult medical personnel immediately. During pregnancy, this drug may harm the fetus, so contraception is advised and administration during pregnancy should be avoided. Nursing mothers should also refrain from using this drug as it may be passed to the baby. This drug may interact with several medications, so inform your healthcare provider if you are taking other drugs. Particular caution is needed when taken with medications that impact the heart or are metabolized by the liver. Caution is advised when driving or operating machinery, as dizziness or seizures may occur. In cases of overdose, hallucinations or abnormal behavior may occur, and immediate medical attention should be sought.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, 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 edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, combative behavior

This medication should be stored in a tightly sealed container to prevent air from entering, at room temperature between 1 and 30 degrees Celsius. Proper storage will safely maintain the drug's efficacy.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle