Fluconazole Capsule (Fluconazole)

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 injectable formulations are the same. Vulvovaginal candidiasis: Administer a single oral dose of 150 mg fluconazole. 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 due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days; local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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 once on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. 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 once 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 generally continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on the patient's risk of fungal infection. 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, 400 mg once daily is recommended. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia, and continue administering 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). Fingernails usually take 3-6 months to regrow and toenails 6-12 months; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For dermatophyte infections, 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 need to continue for 6 weeks, depending on the course. 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 needed 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 > 50: 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 For patients on hemodialysis, administer 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. The safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg per kg of body weight once daily. 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 6-12 mg per kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg per kg of body weight of this medicine on the first day, followed by 6 mg per kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg per kg of body weight once daily. 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 per kg of body weight once daily after the patient has completed primary treatment. Children with renal impairment should have their dosing interval extended and dose reduced according to the same criteria as adults with renal impairment, depending on the degree of renal impairment. When administering doses 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 drug should not be used in certain patients. For example, those allergic to this drug or similar compounds, pregnant women or those who may become pregnant, and breastfeeding women should not use this medication. Also, patients taking certain medications may experience severe side effects, so they should not use this drug. This includes drugs that affect the heart or certain antibiotics, and medications that may cause some types of cardiac arrhythmias should not be used in combination with this drug. This medication contains lactose, so those with lactose intolerance should avoid it. Patients with impaired kidney or liver function, heart disease, or electrolyte imbalances should use this drug with caution, and if necessary, the doctor will adjust the dosage or closely monitor their condition. While this drug generally has good tolerance, in rare cases, abnormalities in blood, liver, or kidneys may occur, requiring regular tests during treatment. Headaches, abdominal pain, diarrhea, rashes, and other side effects may occur during the use of this medication, and severe allergic reactions or liver dysfunction should be reported to a healthcare provider immediately if any unusual symptoms arise. Women who are pregnant or planning to become pregnant should not take this drug and should use an effective method of contraception during treatment and one month after the last dose. Breastfeeding women should avoid taking this medication, as it may pass into breast milk. The safety of this drug in children, especially infants under six months, is not established, so it should be used cautiously only when necessary. Caution is needed while driving or operating machinery as dizziness or seizures may occur when taking this drug. In case of overdose, symptoms such as hallucinations or abnormal behaviors may appear, so immediate medical attention should be sought. This drug is primarily excreted in urine, and if necessary, its blood concentration can be reduced through hemodialysis.

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, indigestion, bloating, dry mouth, increased ALT, increased AST, increased blood 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, malaise, asthenia, fever, hallucinations, paranoid behavior

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, it is important to keep it at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle