Fluconazole Capsule 150 mg

Adult dose

The route of administration should be determined according to the patient’s clinical condition. Because absorption of the oral formulation is rapid and nearly complete, the doses of the oral formulations (tablets, capsules, dry syrup) and injectable formulation are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. 2. 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 once on the first day, followed from the next day by 200 mg once daily. The dose may be increased to 400 mg once daily according to the patient’s response. The duration of administration 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 from the next day by 200-400 mg once daily. The duration of treatment is determined by the clinical and mycological response, but treatment should generally 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 all primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient’s degree of risk for 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 expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 6. Onychomycosis: Administer 150 mg once weekly until the fingernail or toenail has regrown (until a new, uninfected nail has grown). It generally takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary by age and between individuals. In some cases, fingernails or toenails may remain damaged despite 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, treatment of athlete’s foot may need to continue for 6 weeks depending on the course of the disease. 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose, but when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following 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 on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

This medication should not be administered to certain patients. For example, those who are allergic to this medication or similar medications, women who are pregnant or breastfeeding, and patients who are taking specific medications should not use this drug. Additionally, patients with renal or liver dysfunction, cardiovascular diseases, or at risk of arrhythmias should use this medication with caution. It may worsen liver function and affect heart rhythm. This medication is generally well tolerated, but rare cases of abnormal blood, liver, or kidney function may occur, as well as skin rashes or allergic reactions. Symptoms such as headache, dizziness, and indigestion have also been reported. During treatment, it is advisable to have regular blood tests and liver and kidney function tests. Patients with severe illness should be monitored more closely. This medication may interact with various other drugs, so if you are taking other medications, you must inform your healthcare provider. Taking it with certain medications may exacerbate side effects or alter drug effectiveness. Women who are pregnant or may become pregnant should use effective contraception during and for some time after treatment with this medication. High doses during early pregnancy may harm the fetus, so it should be avoided. For breastfeeding women, as this medication is excreted in breast milk, it is safer to either discontinue breastfeeding or not use this medication. Safety in infants under 6 months has not been established, so it should only be used cautiously when absolutely necessary. Caution is required when driving or operating machinery as dizziness or seizures may occur. In the case of overdose, hallucinations or unusual behavior may occur, and immediate medical assistance should be sought. This medication is primarily excreted in the urine, so adequate hydration and, if necessary, blood dialysis may be helpful.

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, liver failure, hepatocyte 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 reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, agitated behavior

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best stored at room temperature between 1°C and 30°C. This way, the medication's effect can be maintained for a long time.

Appearance

Capsule filled with white powder; upper part is dark blue and lower part is light blue.

Package unit

30 capsules/bottle