Fluconazole Capsules (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral 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 pain caused by dentures): The usual dose 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 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 starting the next day. The dose may be increased to up 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 is 400 mg once on the first day, followed by 200-400 mg once daily starting 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 once daily indefinitely after the patient has completed the full course of primary 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 once daily according to the patient's level of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. 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 higher. 7. For fingernail and toenail fungal infections, administer 150 mg once weekly. Continue treatment until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary among individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (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 athlete's foot may need to continue 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, 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose starting the following day as follows. Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not receiving 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

Pediatric doses based on adult doses are generally determined according to the following criteria and must 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, safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, then 3 mg/kg body weight once daily from the following day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, then 3 mg/kg body weight once daily from the following day. Depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. 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 is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine on the first day, then 6 mg/kg body weight once daily from the following day. Depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. 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 body weight once daily after the patient has completed the full course of initial treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering a dose of less than 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication is an azole antifungal and is used for the treatment of fungal infections. This medication should not be administered to certain patients. For example, it should not be taken by individuals allergic to this drug, other azole drugs or excipients, pregnant women or women capable of becoming pregnant, and nursing women. Additionally, concurrent use with certain drugs (e.g., terfenadine, cisapride, astemizole, erythromycin, etc.) can cause cardiac rhythm abnormalities or serious side effects, so such combinations should be avoided. This medication contains lactose and should not be used in patients with lactose intolerance or related genetic disorders. Particular caution is needed for patients with impaired kidney or liver function, heart diseases, or electrolyte imbalances, and regular testing is recommended. This medication is generally well tolerated, but rare side effects may affect the blood, liver, and kidneys, and side effects such as skin rashes, headaches, and digestive disturbances may occur. Due to potential impacts on the heart, patients at risk for QT interval prolongation should exercise caution when taking this medication, as arrhythmias may occur. This drug can interact with various medications, so it is essential to inform healthcare professionals if other medications are being taken. It is best to avoid using this medication during pregnancy, especially in the early stages, as there is a significant risk of harm to the fetus. Nursing women should also refrain from taking this medication, and pediatric patients under 6 months of age should be administered with caution, as safety has not been established for this age group. Caution is advised while driving or operating machinery due to the potential for dizziness or seizures. In the case of overdose, hallucinations or abnormal behaviors may occur, and immediate medical assistance should be sought, including blood dialysis if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, lightheadedness, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance

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

Package unit

30 capsules/bottle