Flucon Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since absorption of the oral formulations is rapid and nearly complete, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose of this medicine 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 of this medicine is 50 mg once daily for 14 days, and 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 of this medicine 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 of this medicine 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 depending on the patient's response. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine 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 should be determined by the 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 this medicine 200 mg once daily indefinitely after the patient has completed the initial treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: This medicine should be administered at 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 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; the growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks depending on the course of the condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medicine is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose; however, when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the next day as follows. Creatinine clearance (mL/min) > 50: Recommended dose 100% of the usual dose Creatinine clearance (mL/min) ≤50 (not on dialysis): Recommended dose 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 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. Safety and efficacy have not been established in infants under 6 months of age. Oropharyngeal candidiasis: Administer this medicine at 6 mg/kg body weight 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 this medicine at 6 mg/kg body weight 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 depending on the patient's response. Administer 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 a dose of 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis: Administer this medicine at 12 mg/kg body weight 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 depending on the patient's response. Continue treatment 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 the initial treatment. 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. For doses under 10 mg, administer the oral syrup or give the injection intravenously according to the child's clinical condition to ensure accurate dosing.

This medication should not be given to certain patients. For example, patients who have a hypersensitivity to this drug, its excipients, or other azole antifungals, pregnant women or women who may become pregnant, and nursing mothers should not use this medication. Additionally, serious side effects may occur if this drug is taken simultaneously with certain medications (e.g., terfenadine, cisapride, astemizole, erythromycin, etc.), thus they should not be used together. This drug contains lactose, therefore it should not be administered to patients with lactose intolerance or specific genetic metabolic disorders. Patients with impaired kidney or liver function, heart disease or electrolyte imbalances, and a history of drug hypersensitivity should use this medication with caution and may require close monitoring by a physician. This drug may affect liver and kidney functions, hence blood tests and liver and kidney function tests are recommended before and during treatment. This medication may impact the electrical activity of the heart; thus, patients with heart disease or a prolonged QT interval should take extra precautions and report any related symptoms to medical professionals immediately. Using this medication during pregnancy may harm the fetus, so fertile women should practice effective contraception during treatment and for one month following the last dose. It is advised that nursing mothers do not take this medication, and particularly in infants younger than six months, safety has not been established, so its use should be exercised cautiously when necessary. Taking this medication may cause dizziness or seizures while driving or operating machinery, so caution is necessary. In the event of an overdose, hallucinations or abnormal behavior may occur, so visiting a medical facility immediately is crucial, and supportive care and gastric lavage may be necessary. Finally, this medication can interact with many other drugs. If taking other medications, it is essential to inform your physician or pharmacist, and when used in conjunction, dosage adjustments and monitoring may be required.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste alterations, tremors, vertigo, Torsade 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, hepatic necrosis, hepatitis, hepatocellular injury, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, behavioral disturbances

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug's effectiveness and safety over time.

Appearance

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

Package unit

For domestic use - 30 capsules/bottle, For domestic use - 100 capsules/bottle