Fluconazole Capsule 150 mg (Fluconazole)

Adult dose

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 (tablets, capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer a single oral dose of 150 mg as fluconazole. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug 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 according to the patient's response. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment depends on the clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug 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, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In 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 higher. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary by individual and age. Occasionally, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris (jock itch), and cutaneous candidiasis: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, tinea pedis may require treatment for 6 weeks depending on the course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. 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. This drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day of treatment 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.

This medication should not be administered to certain patients. First, individuals with a known allergy to this drug or similar components, pregnant women or women who may become pregnant, and breastfeeding women should not take this medication. Additionally, serious side effects may occur when taken with certain drugs, so these combinations should be avoided. Patients with lactose intolerance or particular genetic metabolic disorders should not take this medication. This drug should be used cautiously in patients with renal or hepatic impairment or heart disease. Patients with a history of drug allergies should also be given this medication with caution. This drug can worsen liver function and increase the risk of cardiac rhythm abnormalities, so patients with heart conditions should be especially careful. Dosing adjustments or monitoring may be required when used in combination with certain medications. Generally, this drug has few side effects; however, rare adverse reactions may include decreases in blood cell counts, liver function abnormalities, skin rashes, gastrointestinal symptoms, etc. Severe side effects such as severe liver damage or cardiac arrhythmias have been reported very rarely. If unusual symptoms occur, consult a healthcare professional immediately. While taking this medication, it is advisable to have regular blood tests and tests of liver and kidney functions. Patients with severe illnesses or those taking the drug long term should be particularly cautious. Cardiac rhythm abnormalities may manifest, so the cardiac condition should be closely monitored. This medication interacts with many other drugs, so caution is required depending on the other medications being taken. In particular, when used with drugs affecting the heart, anticoagulants, antidepressants, immunosuppressants, pain relievers, etc., dosing adjustments or monitoring as per a physician's directions may be necessary. It is preferable not to use this medication during pregnancy, and women of childbearing potential should use effective contraception during and after a certain period following the use of this medication. Breastfeeding women are also advised not to use this medication. The safety of this drug in infants under 6 months of age has not been established, so it should only be used with caution when absolutely necessary. When taking this medication, it is important to be cautious as dizziness or seizures may occur while driving or operating machinery. If an overdose occurs, hallucinations or unusual behavior may present, necessitating an immediate visit to a hospital for appropriate treatment. Supportive care and procedures such as gastric lavage or dialysis may be beneficial in cases of overdose.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, blood alkaline phosphatase increase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatic 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 reactions associated with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Doing so will help to retain the medication’s efficacy and stability for a longer duration.

Appearance

Capsule filled with white powder, with a dark blue upper part and a light blue lower part

Package unit

30 capsules/bottle