Miconazole 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. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, and urinary tract infections, etc.): The usual dose of this medicine 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 medicine is 400 mg once 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 usually continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed the full course of primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection 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. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation, who are expected to have severe or prolonged 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 increases to 1,000 cells/mm3 or more. 6. For 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 approximately 6-12 months; growth rates may vary by individual and 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 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. 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. If renal impairment is present (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dose adjustment is required for a single dose, but if multiple doses are required, administer the usual dose only on the first day 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 non-dialysis days, administer a reduced dose according to creatinine clearance.

This medication should not be administered to certain patients. Patients who are allergic to this drug or similar medications, pregnant or nursing women, and those taking specific other medications should not use this drug. Additionally, patients with genetic conditions leading to lactose intolerance should not take this medication. This drug should be used cautiously in some patients. Patients with a history of allergies or impaired renal or liver function, those with heart diseases, or electrolyte imbalances that pose a risk of arrhythmias need to be careful. Special monitoring and dosage adjustments may be necessary when taken with specific other medications. Generally, this medication has few side effects, but it can rarely affect the blood, liver, and kidneys, leading to headaches, dizziness, gastrointestinal disturbances, rashes, etc. People with heart conditions should be particularly careful as it may affect heart rate. It is important to monitor liver and kidney function while taking this medication, and patients with severe illnesses should be observed more closely. Pregnant or nursing women should avoid this drug, and women of childbearing age should use birth control during and for a certain period after treatment. This drug can interact with many other medications, so if taking other medications, it is essential to consult a doctor or pharmacist. Caution is particularly needed when used with heart-affecting medications, anticoagulants, antidepressants, and immunosuppressants. The safety of this drug in children, especially infants under 6 months, has not been established, so it should only be used when necessary. Care should be taken when taking this drug as dizziness or seizures may occur when driving or operating machinery. If overdose occurs, seek immediate medical attention for appropriate treatment, and if necessary, dialysis may be performed to remove the drug.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsades 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, liver failure, hepatocellular necrosis, hepatitis, hepatocyte 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 reactions associated with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the drug's effectiveness and safety.

Appearance

A hard capsule with an upper dark blue and lower light blue shell containing a white to off-white powder.

Package unit

30, 90, 100 capsules per bottle