Anguk Fluconazole Capsule

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 injections are the same. ○ Adults 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 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 infections, 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 once 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 clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug once 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. 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 infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug 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 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 starting 5-6 days before the anticipated onset of neutropenia and continue administering 400 mg 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). Fingernails generally take 3-6 months to regrow and toenails 6-12 months; the rate of growth may vary by individual and age. Even after successful treatment with long-term administration, the 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 of this drug 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 condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should be 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 receiving 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 400 mg. Infants younger than 6 months: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis: 6 mg/kg on the first day, then 3 mg/kg once daily from the following day; administer for at least 2 weeks to prevent recurrence 2. Esophageal candidiasis: 6 mg/kg on the first day, then 3 mg/kg once daily from the following day; increase to up 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): 6-12 mg/kg once daily; determine the duration of treatment based on clinical response and medical judgment 4. Cryptococcal meningitis: 12 mg/kg on the first day, then 6 mg/kg once daily from the following day; increase to 12 mg/kg once daily according to the patient's response; administer for 10-12 weeks after cerebrospinal fluid cultures become negative 5. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg once daily after the patient has completed all initial treatment 6. 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 a dose of less than 10 mg, administer the syrup orally or 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, patients allergic to this medication or similar ingredients, pregnant or breastfeeding women, and patients taking certain medications may be at risk when taking this medication. In addition, patients with kidney or liver dysfunction, with heart disease or at risk of arrhythmia should use this medication cautiously. This medication can worsen liver function and may affect heart rhythms, thus caution is needed. This medication is generally safe but can rarely affect the blood, liver, and kidneys, and side effects such as headache, indigestion, and rash may occur. Especially in severe patients, there is a risk of liver damage, and liver function tests are needed during treatment. During treatment with this medication, attention should be paid to interactions with other medications. Serious side effects can occur if taken with certain medications, so it is essential to consult with a physician or pharmacist. This medication may inhibit various enzymes, thus increasing the concentration of other drugs, so any concurrent medications should be reported. Pregnant women should avoid taking this medication, and women of childbearing age should ensure effective contraception during and for a period after treatment. Breastfeeding women should also avoid taking this medication. Infants and children require special attention, and its safety has not been established for infants under 6 months, so it should only be used when absolutely necessary. Care should be taken when driving or operating machinery as dizziness or seizures may occur during treatment. In the event of an overdose, hallucinations or abnormal behaviors may occur, so immediate contact with a healthcare institution is necessary, and if needed, gastric lavage or supportive treatment is important. This medication is primarily excreted through urine, hence adequate hydration and appropriate treatment are necessary.

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, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug-induced rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a tightly closed container to prevent air or moisture ingress and should be kept at room temperature between 1 to 30 degrees Celsius. This way of storage can help maintain the drug's efficacy for a long time.

Appearance

A hard capsule with a dark blue upper half and a white lower half, containing a white to yellowish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle