Fluconazole 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 injectable formulations are the same. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this medicine once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, urinary tract, etc.): The usual dose is 400 mg of this medicine 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk 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 those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg beginning 5-6 days before the expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. For onychomycosis, administer 150 mg once weekly 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 between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine 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: If renal function is normal, administer the usual adult dose. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or increase the dosing interval. Patients with renal impairment: This medicine is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose, but if 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 days without dialysis, administer a reduced dose 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 maximum. The safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medicine 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 according to the patient's response. Continue treatment for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medicine 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 according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed primary treatment. In children with renal impairment, increase the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment. For 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 instance, individuals who are allergic to this drug or similar components, pregnant or breastfeeding women, and those taking certain medications should avoid using this drug. Additionally, patients with genetic issues, such as lactose intolerance, should avoid taking this drug due to the lactose it contains. This drug should be used cautiously in patients with impaired renal or hepatic function, cardiac disease, or at risk for arrhythmias. Caution is needed, particularly when taken with other drugs that may affect the heart. While this drug typically has few side effects, it may cause hepatic dysfunction, blood disorders, skin rashes, and gastrointestinal symptoms. Should severe side effects occur, immediate consultation with a healthcare professional is necessary. Regular monitoring of liver function and blood tests is crucial during treatment due to the risk of worsening liver function. Kidney function testing is also recommended. This drug may interact with various medications, so if you are taking other medications, be sure to inform your doctor or pharmacist, as dose adjustments or monitoring may be necessary. It is advisable not to use this drug during pregnancy and fertile women should employ effective contraception during treatment and for a certain period afterward. It is also safest for breastfeeding women not to take this drug. Use in infants and children should be approached with caution, especially as safety has not been established for infants under 6 months of age. Be cautious when driving or operating machinery, as this medication can cause dizziness or seizures after administration. In cases of overdose, hallucinations or abnormal behavior may occur, and immediate medical attention is needed. This drug is primarily excreted via urine, so in case of overdose, hemodialysis may be helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, 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, 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 swelling, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. This helps preserve the drug's efficacy and safety over time.

Appearance

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

Package unit

Bottle packaging - 30 capsules/bottle, Bottle packaging - 100 capsules/bottle