Daewon Biotech Fluconazole Tablet 150 mg (Fluconazole)

Adult dose

The route of administration should be determined according to the patient's clinical condition. As absorption of the oral formulation is rapid and nearly complete, the doses of the oral formulations (tablets, capsules, dry syrup) and the injectable formulation are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. 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 is determined based on the 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 the 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 medicine once daily indefinitely after the patient has completed all initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, 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 infections, such as those undergoing bone marrow transplantation who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg beginning 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 higher. 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; growth rates may vary by age and between individuals. In some cases, even after successful long-term treatment, the nails may remain damaged. For cutaneous 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. ○ Older adults If renal function is normal, the usual adult dose should be 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 dosage adjustment is required for a single dose; however, 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 receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On non-dialysis days, the dose should be reduced according to creatinine clearance.

This medication should not be used by certain patients. For example, individuals allergic to this drug or azole medications, women who are pregnant or may become pregnant, and nursing mothers should not take this medication. Additionally, patients currently taking certain other medications should avoid this drug. Especially, it may be dangerous when taken with terfenadine, cisapride, astemizole, erythromycin, pimozide, quinidine, ergotamine, and dihydroergotamine. This medication should be used with caution in patients with kidney or liver dysfunction, and in patients at risk of arrhythmias due to heart disease or electrolyte imbalances. Blood tests and assessments of kidney and liver function are recommended before administration and should be monitored regularly during treatment. This medication can affect heart rhythms, so special caution is needed for patients at risk for heart issues such as QT interval prolongation. Patients with hypokalemia or heart failure are at even higher risk for arrhythmias and should be particularly careful. This drug can interact with multiple other medications, so caution is necessary when taken in combination. Especially, when taken with heart-affecting medications, anticoagulants, anticonvulsants, immunosuppressants, analgesics, antibiotics, etc., it is essential to consult with a doctor or pharmacist. It is advised not to use this medication during pregnancy, particularly in the early stages, as there is a risk of congenital defects occurring in the fetus. Nursing mothers should also refrain from taking this medication, as it can be passed into breast milk. Safety in pediatric patients, particularly those under 6 months of age, has not been established, so administration should only be done cautiously when absolutely necessary. During treatment, care is needed when driving or operating machinery, as dizziness or seizures may occur. In cases of overdose, hallucinations or abnormal behaviors may present, so immediate contact with a medical facility is necessary, and supportive care or gastric lavage may be needed. This drug is primarily excreted in urine, so adequate hydration may be beneficial; it can also be partially eliminated through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, 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, elevated bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Additionally, it is important to maintain a temperature between 1 to 30 degrees Celsius when storing the medication. Storing it this way helps maintain the drug's effectiveness and ensures safe usage.

Appearance

Pink oval tablet

Package unit

30 tablets/bottle