Fluconazole Capsule 50mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this drug 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 of this drug is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this drug 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 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 according to the patient's response. 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 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 the clinical and mycological response, but treatment should generally be given for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 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 of this drug once daily, depending on the patient's degree 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 duration of neutropenia, as in the case of bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before the expected onset of neutropenia and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 7. 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 individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Fungal skin 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 condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients 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 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 undergoing dialysis): 50% of the usual dose Patients undergoing hemodialysis: 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, the dose should be reduced according to creatinine clearance.

Children's dosage

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 Do not exceed 400 mg. The safety and efficacy in infants younger than 6 months have not been established. 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this drug on the first day, followed by 3 mg/kg body weight once daily from the next day. Administer for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this drug on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to 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 body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this drug on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed initial treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the degree of renal impairment, using the same criteria as for adults with renal impairment. When administering a dose of less than 10 mg, give the appropriate amount according to the child's clinical condition, either orally as a syrup or intravenously as an injection.

This medication should not be administered to certain patients. Those who are allergic to this medication or similar medications should not take it. Pregnant women or those who may become pregnant, as well as nursing mothers, should not use this medication. Additionally, patients taking certain medications that may cause serious side effects should not use this medication. This medication contains lactose, so individuals with lactose intolerance or related genetic conditions should not take it. This medication should be used with caution in patients with a history of allergic reactions, kidney or liver dysfunction, heart disease, or electrolyte imbalances. Particularly, individuals at risk for cardiac arrhythmias should be careful when using this medication. Also, since this medication inhibits enzymes that metabolize various drugs in the liver, careful monitoring is needed when used in conjunction with other medications, as drug concentrations may change. This medication is generally well tolerated, but may rarely cause blood disorders, allergic reactions, liver dysfunction, skin rashes, gastrointestinal symptoms, headaches, dizziness, etc. Severe liver damage or cardiac arrhythmias may occur, so consult a healthcare professional immediately if any abnormal symptoms arise. It is advisable to undergo regular blood tests, liver and kidney function tests, and electrolyte tests while taking this medication. Particularly, if liver enzyme levels rise significantly, the use of this medication should be reevaluated. Moreover, patients with cardiac diseases or electrolyte imbalances should be especially cautious of the risk of cardiac arrhythmias. This medication interacts with several drugs, so it should not be used in combination with certain medications. If co-administration is necessary, dosage adjustment and close monitoring are required. In particular, caution should be exercised when using it with drugs that affect the heart, anticoagulants, antidepressants, immunosuppressants, certain chemotherapeutics, and antibiotics. Pregnant women should avoid this medication as it may have serious effects on the fetus. Women of childbearing age should use effective contraception during the course of treatment and for about one month after discontinuation. Nursing mothers should also refrain from using this medication as it can be passed through breast milk. Safety for infants less than 6 months has not been established, and it should only be administered cautiously when absolutely necessary. This medication may cause dizziness or seizures when driving or operating machinery, so caution is advised during such activities. In case of overdose, hallucinations or abnormal behaviors may occur, and prompt medical attention is required. This medication is primarily excreted in the urine, so adequate hydration and, if necessary, hemodialysis can aid its elimination.

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, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular injury, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, altered behavior

This medication may be sensitive to air and humidity, so it should be stored in a tightly closed container. It is best to keep it at room temperature between 1 and 30 degrees Celsius. Doing so helps maintain the medication's effectiveness over time.

Appearance

A hard capsule with a light blue upper part and a white lower part filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle