Fluconazole 50mg Tablet

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since absorption of the oral formulation is rapid and almost complete, the doses of the oral formulations (capsules, tablets, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concomitantly. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg once on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 usually continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after the patient has completed the full course of initial treatment, administer at least 200 mg once daily indefinitely. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg once daily, depending on the patient's level of risk of developing a fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of 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. 7. For onychomycosis, administer 150 mg once weekly and continue treatment until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rate may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermal fungal infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris (jock itch), and cutaneous candidiasis: The usual dose 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 infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose may 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 drug is excreted mainly in the urine unchanged. Dose adjustment is not necessary when administering 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) > 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 days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. Adult dose 100 mg: Pediatric dose 3 mg/kg Adult dose 200 mg: Pediatric dose 6 mg/kg Adult dose 400 mg: Pediatric dose 12 mg/kg However, the safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of this drug on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all initial treatment. 6. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, administer the syrup orally or the injection intravenously according to the child's clinical condition to ensure accurate dosing.

This medication should not be used by individuals with specific allergic reactions, particularly if there has been a hypersensitivity reaction to this drug or similar medications. Pregnant or potentially pregnant women, as well as nursing mothers, should not take this medication, and women planning to become pregnant should use contraception for one month after taking the medication. Patients with heart disease, electrolyte imbalances, or problems with kidney or liver function should use this medication cautiously. Additionally, this medication contains lactose, so it should not be used by individuals with lactose intolerance or specific genetic metabolic disorders. This medication can interact with multiple drugs, so it is essential to inform healthcare providers about other medications being used, especially when taking drugs that affect the heart or are metabolized by the liver. Regular monitoring of liver and kidney function, blood tests, and electrolyte levels is important during the course of treatment. Serious side effects such as liver dysfunction, skin rash, and cardiac arrhythmias can rarely occur, so any unusual symptoms should be reported to a healthcare professional immediately. Care should be taken when driving or operating machinery as dizziness or seizures may occur. In case of overdose, hallucinations or abnormal behavior may manifest, and immediate medical attention is required, with blood dialysis available if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, sensory disturbances, dysgeusia, tremor, 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, hepatic failure, hepatocyte necrosis, hepatitis, hepatocyte damage, 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, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps ensure the safe preservation of the medication's efficacy.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle