Selfnazole 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. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg once daily for 14 days; local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, 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. 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. The dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment is determined according to clinical response and medical judgment. 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 generally continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed initial therapy. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg once daily according to 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 may occur with bone marrow transplantation. In these patients, administer 400 mg beginning 5-6 days before the expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary between individuals and with age. In some cases, nails may remain damaged even after successful treatment with long-term administration. For fungal skin 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 disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. If renal function is normal, the usual adult dose may be given. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This drug is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose; however, when multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the following day as follows: Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤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 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 in infants younger than 6 months have not been established. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg body weight 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. Treat for at least 3 weeks and for at least 2 weeks after symptoms resolve. 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. Cryptococcal meningitis: 12 mg/kg body weight 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. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed initial therapy. Children with renal impairment should have their dosing interval extended and dose reduced according to the same criteria as adult patients with renal impairment. When administering doses below 10 mg, give the oral syrup according to the child's clinical condition or administer the injection intravenously to ensure accurate dosing.

This medication should not be administered to certain patients. For instance, individuals with allergies to this medication or other azole medications, pregnant women or women who may become pregnant, and breastfeeding women should not use it. Additionally, patients currently taking certain medications that can cause heart problems when taken with this drug should avoid it. This medication contains lactose, so patients with genetic diseases such as lactose intolerance or glucose-galactose malabsorption should not take it. When using this medication, special caution should be exercised for patients with kidney or liver dysfunction, heart disease, or those at risk for arrhythmias. It may also interact with other medications, so it's important to consult with a doctor or pharmacist about the medications being taken and to undergo periodic testing. This medication is generally well tolerated, but rare side effects such as blood abnormalities, allergic reactions, liver dysfunction, skin rashes, and gastrointestinal symptoms may occur. If any unusual symptoms occur, medical personnel should be notified immediately. It is advisable to avoid using this medication during pregnancy, particularly in the early stages, as it may harm the fetus. In cases of breastfeeding, the medication may pass into breast milk and affect the infant, thus it should be avoided. The safety of this medication has not been sufficiently established in children, especially infants under 6 months of age, so it should only be used cautiously when necessary. Patients should be cautious as dizziness or seizures may occur after taking this medication when driving or operating machinery. In cases of overdose, hallucinations or abnormal behavior may occur, so appropriate treatment should be sought immediately at a hospital. This medication is primarily excreted in urine, so increasing fluid intake and, if necessary, undergoing hemodialysis may be required.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade 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, 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1°C and 30°C room temperature. Proper storage can help preserve the effectiveness of the medication for a longer duration.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle