Lukozol Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Absorption of the oral formulation is rapid and nearly complete; therefore, the doses of the 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 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 be performed concurrently. 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 starting the next day; the dose may be increased up to 400 mg once daily according to the patient's response. The duration of treatment should be determined according to 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 starting the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should usually 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 all primary treatment. 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 with severe or prolonged neutropenia, as may occur with bone marrow transplantation. In 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 higher. For onychomycosis, administer 150 mg once weekly. Continue treatment until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow and toenails 6-12 months; growth rate may vary between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Fungal skin 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 infection. For pityriasis 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 mainly unchanged in the urine. No dosage 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 following day as follows. Creatinine clearance (mL/min) > 50: 100% of the usual dose Creatinine clearance (mL/min) ≤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 hemodialysis session. On nondialysis days, 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 a maximum of 400 mg. The safety and efficacy of this medicine have not been established in infants younger than 6 months. Oropharyngeal candidiasis: 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: 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 up to 12 mg/kg 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 body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: 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 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: 6 mg/kg body weight once daily after the patient has completed all primary treatment. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses below 10 mg, administer the oral solution or give the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For instance, individuals with allergies to this medication or similar compounds, pregnant or potentially pregnant women, and nursing women should not take this medication. Additionally, patients taking certain medications should exercise caution as combining with this medication could be risky. For example, if taking medication that affects the heart or impacts liver and kidney function, one should discuss with a physician beforehand. Patients with compromised kidney or liver function should use this medication more cautiously due to risks of worsening liver function or heart problems such as arrhythmias, necessitating regular check-ups. Although this medication generally has few side effects, rare occurrences of blood abnormalities, allergic reactions, liver dysfunction, skin rashes, gastrointestinal disturbances, and neurological symptoms may occur. If any of these symptoms arise, promptly inform a healthcare professional. Pregnant or nursing women should avoid this medication, and women of childbearing age should ensure effective contraception during the medication course and for at least one month after discontinuation. This medication can interact with various other drugs. If taking other medications, it is crucial to inform the healthcare provider, as dose adjustments or monitoring may be necessary. When driving or operating machinery, caution is advised as dizziness or seizures may occur. In cases of overdose, hallucinations or abnormal behavior may occur, requiring immediate medical attention, where necessary blood dialysis can reduce the drug concentration.

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, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius to preserve its efficacy and safety over time.

Appearance

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

Package unit

30 capsules/bottle