Fluconazole Capsule 150mg (Fluconazole)
Fluconazole
Prescription medication
Shinil Pharmaceutical Co., Ltd.
MFDS item code 200706790 · Notified 2007.06.12
This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of candidiasis, cryptococcosis, and dermatomycosis; prevention of fungal infections and recurrence
This medication is used to treat acute or recurrent vulvovaginal candidiasis. It is also effective for various invasive candidal infections, including systemic candidiasis such as candidemia and disseminated candidiasis. It is used to treat cryptococcal meningitis and other site infections in patients with normal immune function as well as in immunocompromised patients such as those with AIDS or organ transplants. Additionally, it is used for prophylactic treatment to prevent recurrence of cryptococcosis in AIDS patients. It helps prevent fungal infections in patients experiencing neutropenia due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. Furthermore, it is effective in treating various skin fungal infections including onychomycosis, athlete's foot, and tinea corporis. In summary, this medication is used for the treatment and prevention of various forms of fungal and mold infections.
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. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg as fluconazole. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. ○ 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 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) / Recommended dose > 50 / 100 % of the usual dose ≤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 used in certain patients. For example, it should not be administered to individuals allergic to this drug or similar medications, women who are pregnant or breastfeeding, and patients taking certain heart-related medications. Additionally, patients with impaired kidney or liver function, as well as those with heart disease or at risk for arrhythmias should exercise caution while using this medication. Such patients require careful monitoring and examination by a physician. While taking this medication, rare side effects such as blood abnormalities, allergic reactions, liver dysfunction, dyspepsia, skin rash, and neurological symptoms may occur. If these symptoms appear, immediate consultation with healthcare personnel is necessary. It is particularly important that this medication can affect liver and kidney function, so receiving blood tests and liver/kidney function tests before and during treatment is crucial. This medication may interact with various drugs; therefore, it is essential to inform your doctor or pharmacist if you are taking other medications and to manage accordingly. Women who are pregnant or may become pregnant should consult with their doctor before use, as this medication could be harmful to the fetus, and effective contraception should be used. Breastfeeding women should also consider discontinuing breastfeeding or exploring other treatment options, as this medication can pass into breast milk and affect the baby. The safety of this medication in children, especially infants under 6 months of age, has not been established, so it should only be used with caution when absolutely necessary. During the use of this medication, caution is advised when driving or operating machinery as dizziness or seizures may occur. In case of overdose, hallucinations or abnormal behavior may result, so immediate medical treatment is required. This medication is primarily excreted in urine, so adequate fluid intake and, if necessary, hemodialysis may be beneficial.
Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, dysesthesia, dysgeusia, tremors, lightheadedness, 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, hepatocyte necrosis, hepatitis, hepatocyte damage, rash, pruritus, 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, psychotic behavior
Not everyone experiences these, and they can vary from person to person.
Store this medication in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1°C and 30°C (room temperature).
Capsule with dark blue upper part filled with white powder and light blue lower part
In-house packaging unit
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.