Canazole Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single 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 caused by dentures): The usual dose is 50 mg of this drug 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 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 from the next day. The dose may be increased to 400 mg once daily according to 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 is 400 mg of this drug 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 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 infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, 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 infection, such as those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia, 400 mg once daily is recommended. In these patients, 400 mg should be administered starting 5-6 days before neutropenia is expected to begin, and continued 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 6-12 months; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. 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 weekly for 2-4 weeks. However, in cases of athlete's foot, treatment for 6 weeks may be necessary 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 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 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, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on the adult dose are generally determined according to the following guidelines and should not exceed 400 mg. Adult dose 100 mg: 3 mg/kg Adult dose 200 mg: 6 mg/kg Adult dose 400 mg: 12 mg/kg However, safety and efficacy have not been established in infants under 6 months of age (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. Treatment should be continued 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. The dose may be increased to 12 mg/kg 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 (peritoneum, endocardium, lungs, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment is 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. The dose may be increased to 12 mg/kg once daily according to the patient's response. 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 degree of renal impairment, using the same criteria as for adults with renal impairment. When administering a dose of less than 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 administered to certain patients. First, patients who have had allergic reactions to this medication or other azole medications should not use it. Second, women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Third, patients taking certain heart-related medications or some other drugs should not use this medication together as it may increase the risk of cardiac side effects. Fourth, patients with lactose intolerance or certain genetic metabolic disorders should not take this medication due to the lactose it contains. In addition, this medication should be administered with caution to patients with kidney or liver function issues, or those with heart diseases or electrolyte imbalances. Patients with a history of drug allergies also require caution. This medication can affect liver function, so it is important to have regular liver function tests during treatment. Cardiac rhythm abnormalities may occur, so patients with heart disease should be especially cautious. This medication interacts with many drugs, so patients should always consult with their doctor or pharmacist if they are taking other medications. Care should be taken especially with medications that affect the heart, anticoagulants, anticonvulsants, immunosuppressants, and some antibiotics. During pregnancy, this medication can be harmful to the fetus, so individuals who are planning to become pregnant or are pregnant should consult with a healthcare professional. While breastfeeding, this medication may transfer into breast milk and affect the baby, so it is generally recommended not to use it. This medication should only be given to young children, especially infants under 6 months of age, when it is absolutely necessary as its safety and efficacy have not been adequately established. When taking this medication, there may be dizziness or seizures, so care should be taken when driving or operating machinery. In the event of an overdose, hallucinations or abnormal behavior may occur, so immediate hospital treatment is required. This medication is primarily excreted in urine, so adequate fluid intake and blood dialysis, if necessary, may be beneficial.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, 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, liver failure, hepatocellular necrosis, hepatitis, hepatocyte injury, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reactions accompanied by eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, aggressive behavior

This medication should be stored in a tightly closed container to prevent air and moisture ingress, ideally at room temperatures between 1 to 30 degrees Celsius. Storing it this way helps to maintain the effectiveness of the medication and prevent deterioration.

Appearance

A hard capsule with a turquoise-colored upper part and a pale yellow-colored lower part filled with white powder.

Package unit

100 capsules/bottle, 30 capsules/bottle