Fluconazole Capsule 50mg

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. Vaginal candidiasis: Administer a single 150 mg oral dose of fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg 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 once daily for 14 days. Local disinfection of the dentures should also be performed. 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. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg as a single dose 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 according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg as a single dose 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg 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 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 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. 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 new fingernails to grow and 6-12 months for toenails; growth rates may vary by individual and age. In some cases, the nails may remain damaged after successful treatment with long-term use. Dermatophyte infections, including tinea pedis, tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of tinea pedis may need to continue for 6 weeks depending on the course of the infection. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. Older adults: If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: This drug is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose. If multiple doses are required, administer the usual dose only on the first day, then adjust the dose from the next day as follows: Creatinine clearance > 50 mL/min: 100% of the usual dose Creatinine clearance ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, 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. The safety and efficacy have not been established in infants younger than 6 months. 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. Treatment should continue for at least 2 weeks to prevent recurrence. 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. Treat 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 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. 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 body weight once daily after the patient has completed primary treatment. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, give the oral syrup or intravenous injection according to the child's clinical condition to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals with allergies to this drug or similar drugs, pregnant or nursing women should not take this medication. Additionally, patients with specific heart conditions, electrolyte abnormalities, or those taking certain other drugs should use this medication with caution. This drug contains lactose, so individuals with hereditary lactose intolerance should avoid taking it. Patients with impaired kidney or liver function should exercise caution when using this medication, and dosage adjustments may be necessary. During treatment, side effects such as headache, abdominal pain, diarrhea, and rash may occur, and in rare cases, serious liver damage or cardiac arrhythmias may arise. Particularly, patients with severe diseases should undergo regular blood tests and liver and kidney function tests, and should consult a doctor immediately if abnormalities are found. This drug interacts with many medications, so patients taking other medications should consult a doctor or pharmacist. Pregnant women or those who might become pregnant should use appropriate contraception before and after taking this medication, as it is not safe to use during pregnancy. Nursing women should avoid taking this medication, as it is excreted in breast milk. Safety in infants under 6 months is not confirmed, so it should only be used when necessary. Dizziness or seizures may occur while driving or operating machinery, so caution is advised. In case of overdose, hallucinations or abnormal behavior may occur, so immediate medical attention is necessary. This medication is primarily excreted through urine, so in case of overdose, blood dialysis can help lower drug concentration.

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 blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocyte 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, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to safely preserve its effectiveness.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle