Yunazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral preparations are absorbed rapidly and almost completely; therefore, the doses of oral preparations (capsules, dry syrup) and injectable preparations are the same. 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug 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 is 50 mg of this drug once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this drug 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 is 400 mg of this drug once 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 should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, after the patient has completed primary treatment, administer 200 mg of this drug once daily indefinitely. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections 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 degree of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. 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. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary by age and from person to person. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this drug 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 tinea versicolor, administer 50 mg once daily for 2-4 weeks. For patients with normal renal function, 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. This drug is excreted mainly unchanged in the urine. No dosage adjustment is necessary for a single dose, but 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 (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not on dialysis): 50% of the usual dose Creatinine clearance (mL/min) 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 days when dialysis is not performed, the dose should be reduced 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 drug have not been established in infants younger than 6 months of age (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg per kg of body weight on the first day, followed by 3 mg per kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg per kg of body weight 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 have resolved. 3. 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 treatment duration should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg per kg of body weight 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. 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 per 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 severity of renal impairment, using the same criteria as for adults with renal impairment. When administering doses below 10 mg, use oral syrup or intravenous injection according to the child's clinical condition to ensure accurate dosing.

This medication should not be administered to certain patients. Firstly, those who are allergic to this drug or have experienced hypersensitivity reactions to similar medications should not take it. Pregnant or potentially pregnant women, as well as nursing mothers, should also avoid this medication. Additionally, it can cause severe side effects when taken with certain drugs; therefore, if you are currently taking other medications, you must consult with a doctor or pharmacist. In particular, it should not be taken alongside heart-related medications, certain antibiotics, or drugs that affect heart rhythm. This medication contains lactose, so patients with lactose intolerance or specific metabolic disorders should not take it. When using this medication, it should be used with caution in patients with poor kidney or liver function, those with heart disease, or electrolyte imbalances. Also, patients with a history of drug hypersensitivity should exercise caution. This medication can affect liver function, making regular liver function tests important to monitor. Since heart rhythm abnormalities can occur, patients with heart issues require more careful observation. Generally, this medication is well tolerated, but there can be rare adverse reactions affecting blood, immune system, nervous system, heart, liver, skin, and other areas. For instance, headaches, abdominal pain, diarrhea, and rashes can commonly occur, and in serious cases, dangerous side effects like liver damage or cardiac arrhythmias have been reported. Therefore, if any unusual symptoms appear, you should immediately consult with a medical professional. During the course of this medication, regular blood tests, liver and kidney function tests, and electrolyte tests are recommended. Particularly, as it can affect heart rhythm, an electrocardiogram may be necessary. Furthermore, cases of adrenal insufficiency have been reported while taking this medication, so caution is warranted. This drug has many interactions with other medications, and the effects or risks of side effects can change depending on the drugs you are taking simultaneously. Therefore, it is essential to follow the instructions of healthcare professionals when combining it with medications that affect heart rhythm, anticoagulants, anticonvulsants, immunosuppressants, antineoplastics, analgesics, antibiotics, etc. You must inform healthcare providers of all medications being taken, and consultation is necessary when starting any new medication. During pregnancy, this medication can have severe effects on the fetus, so women planning pregnancy or who could get pregnant must consult with a doctor before taking this medication and should use effective contraception while taking it. Nursing mothers should also avoid this medication as it can be excreted in breast milk and affect the infant. For infants under 6 months of age, the safety and efficacy of this medication have not been adequately established, so it should only be used cautiously when necessary. When driving or operating machinery, caution is advised as this medication can cause dizziness or seizures. Lastly, if this drug is overdosed, hallucinations or abnormal behaviors may occur, necessitating immediate medical attention for appropriate treatment. This medication is mainly excreted through urine, so adequate fluid intake and, if necessary, hemodialysis can help facilitate its removal.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, elevated ALT, elevated AST, increased serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, pruritus, 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, agitated behavior

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle