Readcozol 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. 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose 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 due to dentures): The usual dose 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, and mucocutaneous candidiasis, excluding vaginal candidiasis): The usual dose 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 is 400 mg 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 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, administer 200 mg 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 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 infections, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before the onset of neutropenia is expected, 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 approximately 6-12 months; the rate of growth may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged even 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 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 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 necessary when administering a single dose. However, when multiple doses are required, administer the usual dose only on the first day, 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 undergoing 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

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 Do not exceed a maximum of 400 mg. Safety and efficacy have not been established in infants younger than 6 months. 1. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. The dose may be increased to 12 mg/kg of body weight once daily depending on 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 of body weight once daily. The duration of administration is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, followed by 6 mg/kg of body weight once daily from the next day. The dose may be increased to 12 mg/kg of body weight once daily depending on 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 of body weight once daily after the patient has completed all initial treatment. 6. In pediatric patients 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 doses below 10 mg, administer the syrup orally or inject the solution intravenously according to the child's clinical condition to ensure accurate dosing.

This medication should not be administered to certain patients. For example, patients with allergies to this drug or other azole-class medications, pregnant or potentially pregnant women, and breastfeeding women should not use this medication. Moreover, caution is needed when used in combination with certain drugs, as there is an increased risk of side effects. For instance, co-administration with terfenadine, cisapride, astemizole, or erythromycin may result in serious cardiac issues such as arrhythmias; therefore, co-use should be avoided. This medication contains lactose, therefore patients with lactose intolerance or related genetic issues should refrain from taking it. Patients with impaired kidney or liver function, heart disease, or those at risk of arrhythmias due to electrolyte imbalances should exercise extra caution while using this medication, and regular check-ups are necessary due to the possibility of liver function deterioration. This medication can interact with various drugs, particularly inhibiting CYP enzymes, which may increase the concentration of other drugs and raise the risk of side effects. Therefore, if the patient is taking other medications, they should consult a physician or pharmacist. The use of this medication during pregnancy may harm the fetus; thus, women planning a pregnancy should use effective contraceptives during treatment and for about one month after the last dose, and avoid use while pregnant. Breastfeeding women are also advised not to take this medication unless consulting a doctor when necessary. Safety in children, especially infants under 6 months old, has not been fully established, thus it should only be used cautiously if necessary. During the course of treatment with this medication, dizziness or seizures may occasionally occur, necessitating caution when driving or operating machinery. In cases of overdose, hallucinations or unusual behaviors may occur, and the patient should immediately contact a medical institution for appropriate treatment. This medication is primarily excreted via urine, hence adequate hydration and blood dialysis when necessary can aid in eliminating the drug.

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, gastritis, 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 reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This ensures the medicine's effectiveness and safety for a longer period.

Appearance

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

Package unit

30 capsules/bottle