Self-Nazole 150 mg (Fluconazole)
Fluconazole 150mg
Tablet · Prescription medication
NBK Pharmaceutical Co., Ltd.
MFDS item code 202000803 · Approved 2020.02.11
This product's status changed to Approval withdrawn on 2024.07.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of candidiasis (vaginal and systemic), skin infections, and cryptococcosis; prevention of fungal infections and recurrence
This medication is used to treat acute or recurrent vulvovaginal candidiasis, systemic candidiasis (including bloodstream, peritoneal, endocardial, pulmonary, and urinary tract infections), as well as cryptococcal meningitis and systemic infections in immunocompetent and immunocompromised patients. It is also effective for prophylaxis of cryptococcal recurrence in patients with AIDS. It helps prevent fungal infections in patients with weakened immune systems due to cytotoxic chemotherapy, radiation therapy, and bone marrow transplants. Additionally, it is used to treat various skin fungal infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. This medication acts effectively against a wide range of fungal infections, improving the symptoms of patients.
The route of administration is 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 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 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 depending on the patient's response. The duration of administration is 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 is determined by clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all primary treatment. 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 drug 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 infections, 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 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 about 6-12 months; the growth rate may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug 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 drug is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose; however, when 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 by individuals with specific allergic reactions or by women who are pregnant or breastfeeding. Special caution is required for patients with heart issues or problems related to kidney and liver function while using this medication. As this medication can interact with various other drugs, it is essential to consult your physician or pharmacist if you are taking any other medications simultaneously. During treatment, it is important to regularly monitor liver and kidney function, as well as blood counts. Women of childbearing age should use effective contraception during and for a period after taking this medication. This medication can rarely cause irregular heartbeats, so those with heart disease should exercise extra caution. Dizziness, drowsiness, and headaches may occur, so care should be taken when driving or operating machinery. In cases of overdose, hallucinations or abnormal behavior may occur, so the dosage should be strictly followed, and immediate medical attention should be sought if overdose is suspected. This medication contains lactose and should not be used by individuals who are lactose intolerant. In children, safety has not been established for those under 6 months of age, and it should only be used in special circumstances.
Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, ALT increase, AST increase, 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 generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, behavioral disturbances
Not everyone experiences these, and they can vary from person to person.
This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is crucial to maintain room temperature between 1°C and 30°C. Proper storage will safeguard the effectiveness of the medication.
Pink rectangular tablet
30 tablets/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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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.