Lunazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since oral preparations are rapidly and almost completely absorbed, the doses of oral preparations (capsules, dry syrup) and injectable preparations are the same. Vaginal candidiasis: Administer a single 150 mg oral dose of 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, together with local disinfection of the dentures. 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. 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 following day; the dose may be increased to up to 400 mg once daily according to the patient's response. Determine the duration of treatment based on 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 following day. The duration of treatment depends on 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 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, depending on the patient's 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. For these patients, administer 400 mg starting 5-6 days before the anticipated 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). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; growth rates may vary by individual and age. In some cases, the nails may remain damaged even after successful long-term treatment. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, 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, athlete's foot may require treatment for 6 weeks, depending on the response. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Elderly patients: Use the usual adult dose if renal function is normal. If renal impairment is present (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: No dose adjustment is needed for a single dose. If multiple doses are required, administer the usual dose on the first day only, and from the following day administer 100 % of the usual dose if creatinine clearance > 50 mL/min, 50% of the usual dose if ≤50 (not on dialysis), and 100% of the usual dose after each hemodialysis session in patients on hemodialysis. Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days without dialysis, reduce the dose according to creatinine clearance.

Children's dosage

Pediatric doses corresponding to adult doses: Adult dose 100 mg: 3 mg/kg Adult dose 200 mg: 6 mg/kg Adult dose 400 mg: 12 mg/kg Do not exceed 400 mg. 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 relapse, treatment should be continued for at least 2 weeks. Esophageal candidiasis: Administer 6 mg/kg of this drug 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 according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms have resolved. 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 the clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this drug 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 according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After the patient has completed primary treatment, administer 6 mg/kg once daily. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses below 10 mg, administer the syrup orally or inject the solution intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. For example, individuals allergic to this drug or other azole medications, pregnant women or women who may become pregnant, and breastfeeding mothers should not use this drug. Additionally, caution is required when taken with certain medications as it may pose risks. For instance, it should not be taken with drugs that can affect the heart, such as terfenadine, cisapride, astemizole, and erythromycin. This drug contains lactose, so individuals with lactose intolerance should avoid it. Patients with kidney or liver dysfunction should use this medication with extra caution, and those with a risk of arrhythmia due to heart disease or electrolyte imbalance should also be careful. This drug can affect liver function, so it is advisable to undergo regular liver function tests. In rare cases, some patients may experience side effects such as a decrease in blood cell counts, allergic reactions, liver damage, skin rashes, etc. During pregnancy, this medication may be harmful to the fetus, so it should not be used. Particularly in early pregnancy, the risk of miscarriage or congenital malformations may increase. Breastfeeding women should also avoid this drug as it is excreted in breast milk. For children under 6 months of age, safety has not been established, so it should only be used with caution when absolutely necessary. Patients taking this medication should be careful as dizziness or seizures may occur while driving or operating machinery. In cases of overdose, hallucinations or unusual behavior may occur, so it is essential to adhere to the prescribed dose and consult a healthcare professional immediately in case of overdose. This drug may interact with various medications, so it is imperative to consult a doctor or pharmacist if taking other medications, and to undergo regular blood tests and examinations of liver and kidney function during treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, distension, dry mouth, ALT increase, AST increase, increase in blood alkaline phosphatase, cholestasis, jaundice, increase in 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, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Furthermore, it is important to maintain the effect of the medication by storing it in a cool place at temperatures between 1 and 30 degrees Celsius.

Appearance

Hard capsule with the upper part in blue and the lower part in white, containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle