Ianzole 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. Vulvovaginal 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 due to dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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 starting 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 the 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 starting the next day. The duration of treatment is determined by the clinical and mycological responses, but treatment should generally continue for at least 6 ~ 8 weeks. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After the patient has completed all initial treatment, administer 200 mg once daily indefinitely. 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, who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 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 among individuals according to age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections of the skin, 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. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Older adults: 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 unchanged in the urine. No dose adjustment is necessary when administering a single dose. However, if multiple doses are required, administer the usual dose only on the first day and adjust the dose starting the next day as follows. Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤50 (not on dialysis) mL/min: 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

Pediatric dose corresponding to an adult dose of 100 mg: 3 mg/kg Pediatric dose corresponding to an adult dose of 200 mg: 6 mg/kg Pediatric dose corresponding to an adult dose of 400 mg: 12 mg/kg Do not exceed 400 mg. Safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: 6 mg/kg on the first day, followed by 3 mg/kg once daily starting the next day. Treatment should be continued for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg on the first day, followed by 3 mg/kg once daily starting the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treatment should be continued 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.): administer 6-12 mg/kg once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: 12 mg/kg on the first day, followed by 6 mg/kg once daily starting the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treatment should be continued for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: administer 6 mg/kg once daily after the patient has completed all initial treatment. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering doses of less than 10 mg, administer the syrup orally according to the child's clinical condition or administer the injection intravenously to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals allergic to this medication or other azole drugs should not take it, nor should women who are pregnant or breastfeeding. Severe side effects may occur if taken with certain medications, so co-administration should be avoided. Since this medication contains lactose, it should not be administered to patients with lactose intolerance or related genetic disorders. Prior to administration, patients with a history of drug allergies or issues with kidney or liver function, as well as those with heart disease or at risk for arrhythmias, should use this drug cautiously. Strict monitoring and testing by a physician are necessary. This drug can affect liver and kidney functions, thus blood tests and liver and kidney function tests are recommended prior to administration. Regular check-ups are also necessary during treatment. This drug can interact with various other medications, particularly those affecting the heart or those broken down via specific enzyme metabolic pathways. Therefore, it is essential to inform healthcare personnel of all medications currently being taken while on this drug. Use of this medication during pregnancy may harm the fetus and should be avoided; women of childbearing age should implement effective contraception during and for a certain period after treatment. Breastfeeding mothers should also avoid taking this medication. Safety has not been established in children, especially in infants younger than six months, so it should only be used under medical advice when absolutely necessary. This medication can rarely cause side effects such as headache, dizziness, rash, liver function abnormalities, and gastrointestinal disturbances, and there are risks of severe allergic reactions or hepatotoxicity. Immediate consultation with a healthcare provider is required if any unusual symptoms occur. Caution is necessary when driving or operating machinery, as dizziness or seizures may occur after taking this medication. Overdose may lead to hallucinations or behavioral abnormalities, necessitating immediate medical attention. Since the drug is primarily excreted through urine, blood dialysis may be helpful in cases of overdose.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, 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 protect it from air and moisture. It is best to maintain a room temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle