Inoconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient’s clinical condition. Oral formulations are rapidly and almost completely absorbed; 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 of this medicine 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 of this medicine is 50 mg once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (including esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, and mucocutaneous candidiasis, excluding vaginal candidiasis): The usual dose of this medicine 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 of this medicine 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 of this medicine 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 be given for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. 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 of this medicine once daily according to the patient’s risk of fungal infection. For patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation, in whom severe neutropenia or prolonged neutropenia is anticipated, 400 mg once daily is recommended. For these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the nails grow back (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; growth rates may vary between individuals and with age. Occasionally, nails may remain damaged even after successful treatment with long-term administration. Dermatophyte infections, including athlete’s foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine 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 condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medicine is excreted mainly unchanged in the urine. No dose adjustment is needed for a single dose. If multiple doses are required, administer the usual dose on the first day only, 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 receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, 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 a maximum of 400 mg. The safety and efficacy of this medicine in infants under 6 months of age have not been established. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day, for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day; may be increased to 12 mg/kg of body weight once daily according to the patient’s response; 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 of body weight once daily. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, followed by 6 mg/kg of body weight once daily from the next day; may be increased to 12 mg/kg of body weight once daily according to the patient’s response; for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg of body weight once daily after the patient has completed primary treatment. In children with renal impairment, the dosing interval should be extended and the dose reduced 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 inject the injectable formulation intravenously, according to the child’s clinical condition, to ensure an accurate dose.

This medication should not be used in patients who have experienced certain allergic reactions, or in pregnant or breastfeeding women. Additionally, patients taking specific other medications should avoid this drug due to the risk of heart rhythm disturbances or serious side effects. It is also unsuitable for patients with genetic lactose-related disorders. Patients with kidney or liver function issues should use this medication with caution, especially those with heart disease or electrolyte abnormalities due to the risk of arrhythmias. This medication may interact with multiple drugs, so patients taking concomitant medications must consult their doctor or pharmacist, and dosage adjustment or monitoring may be necessary. Some patients may experience side effects such as headaches, dyspepsia, rashes, and liver function abnormalities; if any unusual symptoms occur, medical personnel should be notified immediately. The use during pregnancy may be harmful to the fetus, so women of childbearing age must use effective contraception during and after the treatment period. It is also advisable for breastfeeding women to avoid taking this drug. Safety and efficacy in infants or children have not been sufficiently established, so it should only be used when absolutely necessary. Caution is advised during driving or operating machinery due to the possibility of dizziness or seizures. In cases of overdose, hallucinations or abnormal behavior may occur, warranting immediate medical attention.

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, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic 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, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it should be kept at room temperature between 1°C and 30°C. Storing it this way helps maintain the drug's effectiveness for a long time.

Appearance

Capsule filled with white powder; upper part is blue, and lower part is white

Package unit

30 capsules/bottle, 100 capsules/bottle