Flucon Capsule (Fluconazole)

Adult dosage

The route of administration is determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 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 of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg of this medicine once daily for 14 days, and local disinfection of the dentures should be performed concomitantly. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, 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. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this medicine 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 the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine 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 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 medicine 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 medicine once daily according to the patient's level 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 undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, and continue administering 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 fingernail or toenail has regrown (until a new, uninfected nail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary between individuals and according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For dermatophyte infections, including athlete's foot (tinea pedis), ringworm of the body (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, treatment of athlete's foot may be required 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 is 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 primarily in the urine unchanged. No dose adjustment is necessary when it is administered only once. 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 on dialysis): 50% of the usual dose Patients on 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 days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on the adult dose are generally determined according to the following guidelines and should not exceed 400 mg. 100 mg: 3 mg/kg 200 mg: 6 mg/kg 400 mg: 12 mg/kg Safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. To prevent recurrence, administer for at least 2 weeks. 2. Esophageal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg 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 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 drug on the first day, followed by 6 mg/kg once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg 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 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 inject the injectable formulation intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, those with allergies to this medication or similar drugs, pregnant women or those who may become pregnant, and breastfeeding women should not take this medication. Additionally, patients taking certain other drugs should avoid concomitant use with this medication. Particularly, medications that could affect the heart or those with significant drug interactions should not be taken together. This medication contains lactose, so caution is required for patients with lactose intolerance or related genetic disorders. Patients with a history of drug hypersensitivity or issues with kidney and liver function, as well as those with heart disease or electrolyte abnormalities, should use this medication cautiously. In these cases, thorough observation and testing by a doctor are required. Various side effects may occur while taking this medication. The most common side effects include headache, abdominal pain, diarrhea, nausea, and abnormal liver function, and rarely, serious skin reactions, liver damage, and blood abnormalities may occur. Especially in patients with heart problems, the risk of cardiac side effects such as arrhythmias or QT interval prolongation should be noted. This medication can interact with many other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Some drugs may change blood concentration when taken with this medication, increasing the risk of side effects. Use of this medication should be avoided during pregnancy, and women of childbearing age should take effective contraceptive measures during and for a certain period after the use of this medication. It is also safer for breastfeeding women to not take this medication. Safety for infants under 6 months has not been established, so it should only be used carefully when absolutely necessary. Caution is needed during use, as dizziness or seizures may occur while driving or operating machinery. In cases of overdose, hallucinations or abnormal behavior may appear, and immediate medical attention is required. Supportive care and potentially procedures such as dialysis may be necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic 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, paranoid behavior

This medication is susceptible to air and humidity, so it should be stored in a tightly closed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

A hard capsule with a powder filled inside; light blue on the upper side and white on the lower side.

Package unit

30 capsules/bottle, 100 capsules/bottle