Viewing nowFlucnal Capsule (Fluconazole)
Fluconazole 50mg
Hard capsule · Prescription medication
Kips Biopharma Co., Ltd.

MFDS item code 200404856 · Notified 2004.12.22 · Insurance code 693200520
Treatment of fungal infections (Candida, Cryptococcus, dermatophytes, etc.); prevention of recurrence and infection
This medicine is used to treat acute or recurrent vaginal candidiasis. It is effective for various mucosal candidiasis including oropharyngeal, esophageal, non-invasive bronchial, and skin mucosal candidiasis. It is also used for the treatment of candidemia and invasive candidiasis spread throughout the body, including peritoneum, lungs, and urinary tract. It helps treat cryptococcal meningitis and cryptococcosis in other body locations in patients with impaired immune function. Prophylactic therapy for preventing recurrence of cryptococcosis in AIDS patients is also applicable, and it is used to prevent fungal infections due to cytotoxic chemotherapy or radiotherapy. Lastly, it is effective for the treatment of various skin fungal infections such as onychomycosis, tinea pedis, and tinea corporis.
The route of administration should be determined according to the patient's clinical condition. Because oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer a single 150 mg dose of fluconazole orally. 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 caused by dentures): The usual dose is 50 mg of this medicine once daily for 14 days, with concurrent 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this medicine once on the first day, followed by 200 mg once daily starting 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 by 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 starting 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. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed all initial therapy, administer 200 mg of this medicine once daily indefinitely. 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 starting 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. Onychomycosis of the fingernails or toenails: Administer 150 mg once weekly until the fingernails or toenails regrow (until new, uninfected nails have grown). Fingernails usually take 3-6 months to regrow and toenails 6-12 months; growth rate may vary by individual and age. Dermatophyte infections of the skin, 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, treatment of athlete's foot may be required for up to 6 weeks depending on the course of the disease. 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), reduce the dose or extend the dosing interval. Patients with renal impairment: No dose adjustment is required for a single dose. If multiple doses are required, administer the usual dose only on the first day and adjust the dose starting the next day. 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 non-dialysis days, administer a reduced dose according to creatinine clearance.
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. Infants under 6 months of age: Safety and efficacy have not been established. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily starting the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily starting the next day. The dose may be increased to 12 mg/kg of 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.): 6-12 mg/kg of body weight once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, followed by 6 mg/kg of body weight once daily starting the next day. The dose may be increased to 12 mg/kg of body weight once daily according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed all initial therapy, administer 6 mg/kg of body weight once daily. Children with renal impairment: Extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. For doses below 10 mg, administer the oral syrup or intravenous injection according to the child's clinical condition to ensure accurate dosing.
This medication should not be administered to certain patients. For example, patients who have had an allergic reaction to this medication, its excipients, or other azole medications should not use this drug. Additionally, women who are pregnant, potentially pregnant, or breastfeeding should not use this medication. Furthermore, patients who are taking certain medications should not combine them with this medication, particularly those taking terfenadine in high doses, those taking medications that may affect the heart, and those taking ergotamine derivatives. Since this medication contains lactose, patients with lactose intolerance or related genetic issues should avoid using this drug. Patients with kidney or liver dysfunction, heart disease, or electrolyte imbalances that pose a risk for arrhythmias should use this medication cautiously, and those with a history of drug hypersensitivity should also exercise caution. This medication may worsen liver function, so liver health should be continuously monitored. Additionally, any abnormalities related to heart rhythms should be closely monitored. This drug may interact with various medications. Therefore, if you are taking other medications, it is essential to inform your doctor or pharmacist, particularly when taking medications that may affect the heart, liver, or kidneys. While using this medication, rare abnormalities in blood, liver, or kidney function may occur, so regular testing is recommended. Pregnant women should not take this medication, and women of childbearing age should use effective contraception during and for about one month after treatment. It is also safest for nursing mothers to avoid this medication. The safety in children, particularly in infants younger than 6 months, has not been established, so it should be used with caution only when necessary. Care should be taken when driving or operating machinery, as dizziness or seizures may occur. In case of overdose, hallucinations or abnormal behavior may occur, and immediate medical attention should be sought. This drug is primarily excreted in urine, so promoting urination may assist in drug elimination.
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, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte 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, hallucinations, paranoid behavior
Not everyone experiences these, and they can vary from person to person.
This medication must be stored in a tightly closed container to prevent exposure to air or moisture. Also, it is best to store the medication at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and safety.
A hard capsule with a light blue upper part and a white lower part filled with white powder.
30 capsules/bottle, 100 capsules/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.