Flucan Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of oral formulations (capsules, dry syrup) and injections 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; 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 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 usually continue 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 period of neutropenia, as in bone marrow transplantation. In these patients, 400 mg should be administered 5-6 days before the expected onset of neutropenia and continued at 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; the growth rate may vary from person to person depending on age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous fungal infections, including tinea pedis (athlete's foot), tinea corporis, 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, treatment for tinea pedis may be needed 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 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 primarily in the urine unchanged. No dose adjustment is necessary when it is administered only once. When multiple doses are required, administer the usual dose only on the first day of treatment, then 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 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 a maximum of 400 mg. Safety and efficacy have not been established in infants under 6 months of age (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this medication on the first day, then 3 mg/kg once daily from the following day. Treatment should continue for at least 2 weeks to prevent relapse. 2. Esophageal candidiasis: Administer 6 mg/kg of this medication on the first day, then 3 mg/kg once daily from the following day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Continue treatment 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 medication on the first day, then 6 mg/kg once daily from the following 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 relapse 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 degree of renal impairment, using the same criteria as for adults with 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 administered to certain patients. For example, those allergic to this medication or similar class drugs should not use it. Women who are pregnant or potentially pregnant, as well as those who are breastfeeding, should also avoid taking this medication. Additionally, it may pose risks to the heart if taken with certain medications, so consultation with a physician is essential. This medication contains lactose, hence those with lactose intolerance or related genetic conditions should avoid it. Caution should be exercised when using this medication in patients with diminished kidney or liver function, as well as those with heart disease or electrolyte imbalances. Special monitoring by a physician is necessary for patients with heart disease, especially since heart rhythm issues may arise. Furthermore, this medication inhibits enzymes responsible for drug metabolism in the liver, therefore careful dose adjustment and monitoring are crucial when taken with other medications. While generally safe, this medication may rarely cause blood problems or allergic reactions, liver dysfunction, skin rash, and other side effects. Symptoms like abdominal pain, diarrhea, headache, and dizziness may also appear, and if abnormal symptoms occur, consult healthcare professionals immediately. Regular liver and kidney function tests during the use of this medication are recommended. Patients with severe diseases should take precautions as there is a risk of liver damage. Also, this medication can affect cardiac electrical signals, especially caution should be taken for those with heart diseases or electrolyte imbalances. This medication can interact with several other drugs, so if other medications are being taken, it is essential to inform the physician or pharmacist. Extra caution is necessary when combined with drugs that affect the heart, anticoagulants, antidepressants, antibiotics, and antineoplastic agents. It is advisable to avoid this medication during pregnancy, and at least one month of contraception should be practiced after use. Breastfeeding mothers should avoid this medication, as it may affect the baby. Safety has not been established in infants under 6 months of age, and it should only be used cautiously in cases where it is absolutely necessary. Be cautious when driving or operating machinery, as dizziness or seizures may occur. In case of overdose, seek medical attention immediately, and procedures like gastric lavage or dialysis may be performed as necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, lightheadedness, Torsades 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, hepatocellular necrosis, hepatitis, hepatocellular 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, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication can be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. Proper storage helps maintain the effectiveness of the medication for longer.

Appearance

A hard capsule with the upper part in blue and the lower part in white containing white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle