Mycozol 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 as a single oral 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 caused by 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 infection, candiduria, mucocutaneous candidiasis, etc., 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 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 the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after the patient has completed all initial treatment, administer 200 mg of this drug once daily indefinitely. 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, according to the patient's degree of 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 undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or above. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). Regrowth of a new fingernail usually takes 3-6 months, and regrowth of a toenail takes approximately 6-12 months; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, fingernails or toenails may sometimes remain damaged. 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. 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 for a single dose; however, when multiple doses are required, administer the usual dose only on the first day, 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 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Children's dosage

The following general guidelines are used to determine the pediatric dose based on the adult dose; do not exceed 400 mg. Adult dose 100 mg: Pediatric dose 3 mg/kg, maximum 400 mg Adult dose 200 mg: Pediatric dose 6 mg/kg, maximum 400 mg Adult dose 400 mg: Pediatric dose 12 mg/kg, maximum 400 mg The safety and efficacy of this medicine in infants younger than 6 months have not been established. 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight 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 body weight of this medicine 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.): Administer 6-12 mg/kg body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg 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 degree of renal impairment, using the same criteria as for adults with renal impairment. When administering doses below 10 mg, administer the oral syrup or give the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals who have had an allergy to this medication or similar ingredients, pregnant women or those who may become pregnant, and nursing mothers should not take this medication. Additionally, patients taking certain medications that may interact and cause serious side effects should avoid using this product. This includes medications that may affect the heart or certain antibiotics and antiarrhythmics. This medication contains lactose, so patients with metabolic disorders such as lactose intolerance should not take it. When using this medication, it should be administered cautiously to patients with poor kidney or liver function, patients with heart disease or electrolyte disturbances, and those with a history of drug allergies. This medication may affect liver function, so regular liver function testing during treatment is important. Additionally, it may affect heart rhythm, so the patient's heart condition should be closely monitored. This medication can interact with other drugs, so patients taking other medications should inform their healthcare provider, and dose adjustments or monitoring may be necessary. During pregnancy, this medication should be avoided as it may be harmful to the fetus, and effective contraception is needed during treatment and after for a certain period. Nursing mothers are also advised not to take this medication. There is no established safety for this medication in children, particularly infants under 6 months old, and it should only be administered with caution when absolutely necessary. This medication may occasionally cause dizziness or seizures, so caution is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, and immediate consultation with a healthcare provider is necessary for required treatment. This medication is mainly excreted through urine, so adequate hydration may be beneficial.

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, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, elevated 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, malaise, asthenia, fever, hallucinations, paranoid behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance

Capsule filled with white powder, blue upper part and white lower part

Package unit

30 capsules/bottle, 100 capsules/bottle