Clikozole Capsule 50mg (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. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this medicine once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 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 medicine as a single dose 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine 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 clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed initial treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine 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 expected prolonged period of neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg beginning 5-6 days before neutropenia is expected to start, and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 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. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine 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. When 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. This medicine is excreted mainly unchanged in the urine. No dosage adjustment is necessary for a single dose. 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 on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days without dialysis, administer a reduced dose according to creatinine clearance.

Children's dosage

Adult dose 100 mg: Pediatric dose 3 mg/kg, not exceeding a maximum of 400 mg. Adult dose 200 mg: Pediatric dose 6 mg/kg, not exceeding a maximum of 400 mg. Adult dose 400 mg: Pediatric dose 12 mg/kg, not exceeding a maximum of 400 mg. Safety and efficacy have not been established in infants younger than 6 months. Oropharyngeal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg of body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of body weight of this medicine on the first day, followed by 6 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg of body weight once daily after the patient has completed initial treatment. 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 an accurate dose.

This medication should not be administered to certain patients. For example, individuals who are allergic to this drug or similar components, pregnant women or those who may become pregnant, and nursing women should avoid use. Additionally, patients taking specific medications must be cautious as this drug may pose a cardiac risk when taken together. This medication contains lactose and is not suitable for patients with lactose intolerance or certain genetic metabolic disorders. Patients with impaired kidney or liver function, heart disease, or those at risk of arrhythmias should use this medication with caution. Furthermore, this medication can inhibit certain enzymes and increase the blood levels of other drugs, so it is essential to discuss with healthcare providers if taking other medications. While generally well-tolerated, rare side effects such as blood abnormalities, liver dysfunction, skin rashes, and cardiac rhythm abnormalities may occur. It is important to regularly monitor liver function tests during treatment due to the risk of liver function deterioration. Use of this medication during pregnancy may harm the fetus, so women who are pregnant or planning to become pregnant must take contraceptive measures, and it is advisable to avoid use while nursing. Safety in infants under 6 months of age has not been established, so it should only be used cautiously when absolutely necessary. Dizziness or seizures may occur while driving or using machinery, so caution is needed during such activities. In case of overdose, hallucinations or unusual behavior may occur, so immediate medical attention is required. This drug is primarily excreted in urine, therefore sufficient fluid intake and possibly hemodialysis may be necessary for drug elimination.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it is best kept at room temperature in a cool place, preferably between 1°C and 30°C.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle