Fluconazole 150 mg Tablet
Fluconazole
Prescription medication
Mirae Bio Pharmaceutical Co., Ltd.
MFDS item code 200701378 · Notified 2007.01.31
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 Candida infections and cutaneous mycoses; treatment and prevention of recurrence of cryptococcosis; prevention of fungal infections
This medication is used for the treatment of acute or recurrent vulvovaginal candidiasis. It is also effective for treating systemic candidal infections such as candidemia and disseminated candidiasis. It is used to treat cryptococcal meningitis and other infections in patients with compromised immune systems, and it is used to prevent the recurrence of cryptococcal infections in patients with AIDS. Additionally, it helps prevent fungal infections in patients with neutropenia resulting from cytotoxic chemotherapy or radiation therapy. Finally, it is used for the treatment of various skin fungal infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. It is a medication effective for a wide range of fungal infections.
The route of administration should be determined according to the patient's clinical condition. Absorption of oral formulations is rapid and nearly complete; therefore, the doses of oral formulations (tablets, capsules, dry syrup) and injections are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg 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 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 should be 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 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In such patients, administer 400 mg beginning 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. 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 approximately 6-12 months; growth rates may vary by individual and age. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermal fungal 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 its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients Use the usual adult dose if renal function is normal. 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. Dose adjustment is not necessary for a single dose. For multiple doses, 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 receiving dialysis) — 50% of the usual dose Patients receiving 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 may be dangerous for individuals who are allergic to this drug or similar medications, pregnant or breastfeeding women, and patients with certain heart conditions or electrolyte imbalances. Patients with kidney or liver dysfunction should be especially cautious when using this medication. Those with liver disease should undergo liver function tests both before and during treatment due to the potential for liver function deterioration. This medication may affect the heart, and patients with arrhythmias or QT interval prolongation should be particularly careful. Such patients should periodically monitor their heart condition. This medication can interact with various other drugs. Caution is necessary when taken with heart-affecting medications, certain antibiotics, anticoagulants, antidepressants, anticonvulsants, etc., and interaction possibilities with other medications being taken should be discussed with healthcare providers. Pregnant women should avoid using this medication as it may harm the fetus. Women of childbearing age should ensure effective contraception while taking this medication and for about one month following its discontinuation. Nursing mothers should also refrain from using this medication. In pediatric patients, safety in infants under 6 months has not been established, so it should be administered with caution only when necessary. During the use of this medication, dizziness, drowsiness, and seizures may occasionally occur, necessitating caution when driving or operating machinery. In cases of overdose, hallucinations or abnormal behavior may occur, requiring immediate medical attention for appropriate treatment. This medication is primarily excreted through urine, so increasing fluid intake can help with excretion, and blood dialysis may be used if necessary to lower drug concentration. During treatment, regular blood tests, liver function tests, kidney function tests, and electrolyte tests should be conducted to detect adverse reactions or side effects early and respond appropriately.
Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, increased blood 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 reaction with eosinophilia and systemic symptoms (DRESS), myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior
Not everyone experiences these, and they can vary from person to person.
This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature.
Pink oval-shaped tablet
Company 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.