1) Efficacy, effect
1. Acute or recurrent vaginal candidiasis 2. Oropharynx, esophagus, non-invasive bronchopulmonary infection, candiduria, skin mucosa, and chronic atrophic oral candidiasis (intraoral pain caused by dentures) in patients with normal immune function and patients with reduced immune function. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive candidiasis (peritoneum, endocardium, lung, urinary system, etc.) 4. Patients with normal immune function and patients with weakened immune function (AIDS) Cryptococcal meningitis in (AIDS), organ transplant patients, or other immunosuppressive therapy) and cryptococcosis in other parts of the body, such as the lungs and skin. 5. Prevent recurrence of cryptococcosis in AIDS patients. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation 7. Hand and toenail mycosis, athlete's foot (tinea pedis), and corpus Fungal skin infections, including ringworm, jock itch, tinea versicolor, and cutaneous candidiasis
2) Usage, dosage
The route of drug administration is determined according to the clinical condition of the patient. Since oral preparations are absorbed quickly and almost completely, the dosage for oral preparations (capsules, dry syrup) and injection preparations is the same. 1. Adults 1) Vaginal candidiasis: Single oral administration of 150 mg as fluconazole 2) Mucosal candidiasis (1) Oropharyngeal candidiasis This drug is usually administered at 50 mg once a day for 7 to 14 days, and may be administered for an extended period at the doctor's discretion. You can. (2) Chronic atrophic oral candidiasis (intraoral pain caused by dentures) This drug is usually administered at 50 mg once a day for 14 days, and local disinfection of dentures should be performed concurrently. (3) Other mucosal candidiasis (excluding vaginal candidiasis, esophageal candidiasis, non-invasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc.) This drug is usually administered at 50 mg once a day for 14 to 30 days, and is used to treat refractory mucosal candidiasis. In this case, the dose can be increased to 100 mg once a day. 3) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive candida infections (peritoneum, endocardium, lung, urinary system, etc.). This drug is usually administered at 400 mg once on the first day and 200 mg once a day from the next day. Administered in mg, the dose can be increased up to 400 mg once a day depending on the patient's response. The administration period is determined based on clinical response and medical judgment. 4) Cryptococcal meningitis and cryptococcosis in other areas This drug is usually administered at 400 mg once on the first day and then at 200-400 mg once a day from the next day. The duration of treatment is determined by clinical and mycological response, but usually should be administered for at least 6 to 8 weeks. 5) To prevent recurrence of cryptococcal meningitis in AIDS patients, administer at least 200 mg of this drug once a day indefinitely after the patient has received all basic treatment. 6) Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia due to cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Depending on the patient's risk of developing fungal infections, use this drug once a day for 50 doses. – 400 mg should be administered. For patients at very high risk of systemic fungal infection, that is, patients who are expected to have severe neutropenia or a long period of neutropenia, such as in the case of bone marrow transplantation, 400 mg once daily is recommended. To these patients, 400 mg should be administered starting 5 to 6 days before neutropenia is expected to begin, and 400 mg should be continued for one week after the neutrophil count increases to over 1,000 cells/mm3. 7) For hand and toenail mycosis, administer 150 mg once a week until the hands and toenails grow again (until new uninfected hands and toenails grow). It usually takes 3 to 6 months for new fingernails to grow, and 6 to 12 months for toenails, and the growth rate may vary depending on the individual's age. Even after successful treatment with long-term treatment, hands and toenails sometimes remain damaged. Skin fungal infections such as athlete's foot (tinea pedis), tinea corporis, jock itch (tinea groin), and cutaneous candidiasis: This drug is usually administered at 50 mg once a day or 150 mg once a week for 2 to 4 weeks. However, in the case of athlete's foot, administration may be necessary for 6 weeks depending on the course. For tinnitus, administer 50 mg once a day for 2 to 4 weeks. 2. Children The pediatric dose based on the adult dose generally applies the following standards and does not exceed a maximum of 400 mg. Adult dose 100mg-Children's dose 3mg/kg Adult dose 200mg-Children's dose 6mg/kg Adult dose 400mg-Children's dose 12mg/kg However, safety and effectiveness for infants under 6 months of age have not been established (Precautions for use) reference). 1) Oropharyngeal candidiasis: Administer 6 mg per kg of body weight on the first day, and 3 mg per kg of body weight once a day from the next day. It should be administered for at least 2 weeks to prevent recurrence. 2) Esophageal candidiasis: Administer 6 mg per kg of body weight on the first day, and 3 mg per kg of body weight once a day from the next day. Depending on the patient's response, the dose can be increased up to 12 mg per kg of body weight once a day. Administer for at least 3 weeks and for at least 2 weeks after symptoms disappear. 3) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive candidiasis infections (peritoneum, endocardium, lung, urinary system, etc.) Administer 6 to 12 mg per kg of body weight once a day. The administration period is determined based on clinical response and medical judgment. 4) Cryptococcal meningitis: Administer 12 mg per kg of body weight on the first day, and 6 mg per kg of body weight once a day from the next day. Depending on the patient's response, the dose can be increased to 12 mg per kg of body weight once a day. The treatment period is 10 to 12 weeks after a negative cerebrospinal fluid culture result. 5) To prevent recurrence of cryptococcal meningitis in AIDS patients, administer 6 mg per kg of body weight once a day after the patient has received all basic treatment. 6) For children with renal impairment, the dosing interval should be increased and the dose reduced according to the same standards as adult renal impairment patients, depending on the degree of renal impairment. When administering a dose of less than 10 mg, the syrup should be administered orally or the injection should be administered intravenously, depending on the clinical condition of the child, in order to obtain the correct dose. 3. In elderly patients with normal renal function, the adult dose is usually administered. In cases of renal impairment (creatinine clearance less than 50 mL/min), the dosage should be reduced or the interval between administrations should be increased. 4. Patients with renal impairment: This drug is mainly excreted unchanged through urine. If administered only once, there is no need to adjust the dose, but if administered multiple times, the regular dose should be administered only on the first day of administration and the dose should be adjusted as follows from the next day. 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 the creatinine clearance rate.
3) Packaging unit
350mg/35mL
4) Ingredients, content
Fluconazole 1.64g
5) Period of use
E59
24 months from date of manufacture
6) Storage method
Airtight container, stored at room temperature
