Liconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be 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. Vulvovaginal candidiasis: Administer a single oral dose of 150 mg fluconazole. 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; local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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 is determined by 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 is determined by clinical and mycological response, but treatment should generally continue for at least 6–8 weeks. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed primary treatment, 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. For patients at very high risk of systemic fungal infection, such as bone marrow transplant patients with severe neutropenia or anticipated 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 more. Onychomycosis: Administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). Regrowth of a new fingernail generally takes 3–6 months, and toenail regrowth takes approximately 6–12 months; growth rate may vary with age and between individuals. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections of the skin, 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 its course. Tinea versicolor: Administer 50 mg once daily for 2–4 weeks. Older adults: If renal function is normal, the usual adult dose is generally 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: This medicine is excreted primarily in the urine, unchanged. No dose adjustment is necessary for a single dose; however, if multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as follows: 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 receiving hemodialysis should receive 100% of the usual dose after each session. On days when dialysis is not performed, reduce the 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 of this medicine in infants younger than 6 months have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg 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 6–12 mg/kg once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medicine on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Continue treatment 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 primary treatment, administer 6 mg/kg once daily. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, 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 allergic reactions to this drug or similar medications, pregnant women or women who may become pregnant, and breastfeeding women should not use this drug. Additionally, there are specific medications that may be dangerous if taken with this drug. For instance, caution should be exercised when co-administering with medications that can affect the heart, such as terfenadine, cisapride, astemizole, and erythromycin, as they may risk cardiac rhythm disturbances. Patients with lactose intolerance or certain genetic metabolic abnormalities should also avoid this medication, as problems may arise due to lactose contained in the excipients. This medication should be used with caution in patients with renal or liver dysfunction. In particular, patients with impaired liver function or heart disease may face a higher risk of side effects and must follow doctors' directives closely. This medication can interact with various drugs, particularly as it inhibits enzymes that metabolize drugs in the liver, which may lead to increased plasma concentrations of other medications. Therefore, if you are taking other medications, it is essential to inform your healthcare provider and adjust dosages or monitoring as necessary. Routine blood tests, liver function tests, and kidney function tests are recommended during the course of taking this medication to detect adverse reactions or long-term damage early. It is advisable for pregnant or breastfeeding women to avoid using this drug, particularly in early pregnancy when the risk of miscarriage or congenital malformations may increase. The safety for children, particularly infants under 6 months of age, has not been established, so it should be used only when absolutely necessary. Caution is necessary when driving or operating machinery as this medication may cause dizziness or seizures as side effects. If an overdose occurs, hallucinations or abnormal behavior may manifest, and you should contact a healthcare facility immediately for appropriate treatment. This drug is primarily excreted in urine, so adequate hydration and dialysis treatment if necessary may help.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, 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 swelling, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius in a room temperature.

Appearance

A hard capsule containing white to off-white powder with a dark blue upper part and a white lower part

Package unit

30 capsules/bottle