Hanall 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 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 due to dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed at the same time. 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 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 depending on the patient's response. The duration of treatment should be determined based on 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 clinical and mycological response, but treatment should generally be continued for at least 6 ~ 8 weeks. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, after the patient has completed initial therapy, administer 200 mg once daily indefinitely. 6. 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 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 undergoing bone marrow transplantation, or those expected to have severe or prolonged neutropenia. 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 more. 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 about 6-12 months; the growth rate may vary by age and individual. 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 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 needed for a single dose; however, if 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 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, administer a reduced dose 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. The safety and efficacy of this medicine in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, then 3 mg/kg body weight once daily starting the next day; administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: 6 mg/kg body weight on the first day, then 3 mg/kg body weight once daily starting the next day; depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. 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 body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg body weight on the first day, then 6 mg/kg body weight once daily starting the next day; depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. Continue treatment for 10–12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed initial treatment. 6. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. For doses below 10 mg, administer the oral solution by mouth or inject the injection intravenously, as appropriate to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in patients who have specific allergic reactions or hypersensitivity to excipients or azole medications. Women who are pregnant or may become pregnant, as well as breastfeeding women, should avoid taking this medication. Additionally, patients with certain heart conditions or at risk for arrhythmias, as well as those taking multiple medications that interact with this drug, should use this medication with caution. Patients with hereditary lactose intolerance or lactase deficiency should refrain from taking this medication. Those with renal or hepatic impairment should be cautious as this medication may worsen liver function or change kidney function. This medication can affect heart rate, so patients with heart disease or electrolyte imbalances should be especially careful. There are several medications that may pose risks if taken with this drug, so patients taking other medications should always consult with a doctor or pharmacist. This medication generally has good tolerability; however, rare side effects may include abnormalities in the blood, liver, or kidneys, as well as skin rashes, headaches, and gastrointestinal disturbances. If serious skin reactions or symptoms of liver damage occur, medical consultation should be sought immediately. It should be avoided during pregnancy as it may harm the fetus, and women of childbearing potential should practice effective contraception for at least one month after discontinuing this medication. Breastfeeding women are also advised against taking this medication. Safety has not been established for children, particularly infants under 6 months, and caution should be exercised for special cases only. Patients should be aware that dizziness or seizures may occur when driving or operating machinery while using this medication. Overdosing can lead to psychiatric and behavioral changes, thus strict adherence to dosing is necessary.

Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia, Anaphylaxis, Angioedema, Hypertriglyceridemia, Hypercholesterolemia, Hypokalemia, Insomnia, Drowsiness, Headache, Seizures, Dizziness, Paresthesia, Dysgeusia, Tremors, Vertigo, Torsade de pointes, QT prolongation, Abdominal pain, Diarrhea, Nausea, Vomiting, Dyspepsia, Distension, Dry mouth, Increased ALT, Increased AST, Increased serum alkaline phosphatase, Cholestasis, Jaundice, Increased bilirubin, Hepatotoxicity, Liver failure, Hepatocyte necrosis, Hepatitis, Hepatocyte damage, Rash, Itching, Hives, 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, Hallucinations, Paranoid behavior

This medication should be stored in a tightly sealed container to keep out air, and it is best kept at room temperature between 1°C and 30°C. Stored this way, the medication will maintain its efficacy.

Appearance

A hard capsule containing a white to off-white powder with a greenish upper part and a white lower part

Package unit

30 capsules/bottle, 100 capsules/bottle