Fluconazole 150 mg Capsule

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 injections are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 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 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 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 initial therapy. 5. 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, depending on 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 with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased 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 generally take 3-6 months to grow, and toenails take 6-12 months; the growth rate may vary between individuals and with age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For dermatophyte skin 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 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 primarily in the urine unchanged. No dose adjustment is needed 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) / 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 For patients receiving hemodialysis, 100% of the usual dose should be administered after each hemodialysis session. On non-dialysis days, the dose should be reduced according to creatinine clearance.

This drug should not be used in certain patients. Individuals who are allergic to this drug or similar drugs, or have had hypersensitivity reactions should not take it. It is also not safe for pregnant women or those who may become pregnant, and for breastfeeding women. Furthermore, patients taking certain medications alongside this drug should avoid combined use to prevent serious side effects. This drug contains lactose and may not be suitable for those with lactose intolerance or certain genetic disorders. Some patients may require caution when using this drug. Those with a history of drug hypersensitivity, or issues with kidney or liver function should use this drug with caution. Patients at risk of arrhythmias due to heart disease or electrolyte imbalances also need to be cautious. This drug can affect heart electrical activity, so individuals with heart conditions should consult their doctor. Additionally, since this drug inhibits enzymes that metabolize drugs in the liver, careful monitoring is needed for potential interactions with other drugs. While this drug can generally be used safely, it may rarely affect blood, liver, or kidney function. Various side effects such as headache, dyspepsia, abdominal pain, and skin rashes have been reported; hence it is important to notify healthcare personnel immediately if any unusual symptoms occur. It is advisable to avoid this drug during pregnancy, especially in the early stages, as the risk of miscarriage or congenital malformations may increase. In breastfeeding mothers, this drug can be passed into breast milk, so it may be necessary to discontinue breastfeeding or consider other treatment options. This drug has a high potential for drug interactions, so patients taking other medications should inform their doctor or pharmacist. Monitoring and dosage adjustments are especially needed when combined with heart-related medications, anticoagulants, antiepileptics, and immunosuppressants. Dizziness or seizures may occur while driving or operating machinery, so caution is advised. In case of overdose, hallucinations or abnormal behavior may occur, and immediate contact with a healthcare institution is necessary for appropriate treatment. Blood tests, liver and kidney function tests, and electrolyte tests are recommended before using this drug, and regular monitoring during treatment is essential to ensure safety.

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, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocellular injury, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute widespread exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, hallucinations, paranoid behavior

This drug must be stored in a tightly sealed container to avoid exposure to air or moisture. It is best maintained at room temperature between 1°C and 30°C.

Appearance

Capsule filled with white powder, dark blue on the upper side and light blue on the lower side

Package unit

30 capsules/bottle, 100 capsules/bottle