Teluna Capsule 50 milligrams (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. 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this drug is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose of this drug is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this drug is 50 mg once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug 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 to 400 mg once daily according to the patient's response. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug 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 generally be given for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all primary treatment. 6. 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 drug once daily, depending on the patient's level of risk for 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 have severe neutropenia or are expected to have prolonged neutropenia. In these patients, 400 mg should be administered starting 5-6 days before the onset of neutropenia is expected, and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). New fingernails generally take 3-6 months to grow, and toenails take 6-12 months; the rate of growth may vary among individuals according to age. Even after successful treatment with long-term administration, fingernails or toenails may occasionally remain damaged. Cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug 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 condition. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, the usual adult dose should be administered. In the presence of renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. Patients with renal impairment: This drug is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose, but when multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the next 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 be given 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. 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 The safety and efficacy in infants younger than 6 months have not been established. 1. Oropharyngeal candidiasis: Administer 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily starting the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 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 depending on the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer a dose of 6-12 mg/kg of body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 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 depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg of body weight once daily after the patient has completed primary treatment. 6. 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, depending on the degree of renal impairment. For doses below 10 mg, administer the syrup orally according to the child's clinical condition or administer the injection intravenously to ensure accurate dosing.

This medication should not be used in patients with allergies to specific drugs or components. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Patients with heart disease or electrolyte abnormalities, and those with impaired liver or kidney function, need to exercise special caution when using this medication. This medication may interact with various other drugs; therefore, if you are taking other medications, you must inform your physician or pharmacist. It is important to check your condition before and during administration through blood tests, liver function tests, and kidney function tests. This medication can infrequently cause serious liver damage or blood abnormalities, so if unusual symptoms occur, consult medical personnel immediately. While taking this medication, symptoms such as headaches, abdominal pain, diarrhea, and nausea may appear, so be cautious. Because there is a risk of cardiac rhythm disturbances, if any heart-related symptoms occur, seek medical attention immediately. During pregnancy, this medication may harm the fetus; hence, it is essential to use contraception and avoid use if planning to become pregnant. If breastfeeding, as this medication may be transmitted through breast milk, stopping breastfeeding is recommended. The safety of this medication in children, especially infants under 6 months old, has not been established, hence it should be used cautiously. Caution is required while driving or operating machinery due to the potential for dizziness or seizures. In cases of overdose, hallucinations or abnormal behavior may occur, and immediate medical attention is required, including treatments like blood dialysis if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, lightheadedness, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocyte 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, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a sealed container to protect it from exposure to air or moisture. Additionally, it is best to store the drug at a cool room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle