Daycan 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. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose 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 caused by dentures): The usual dose is 50 mg 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 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 as a single dose on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 the clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed all initial treatment. 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 once daily, depending on the patient's level of 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. In these patients, administer 400 mg starting 5-6 days before the onset of neutropenia is expected, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernail or toenail has regrown (until new, uninfected nail has 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 individual and age. In some cases, the nails may remain damaged after successful treatment with long-term administration. 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 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. ○ Elderly patients If renal function is normal, the usual adult dose may be administered. In patients with 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; however, 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 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, administer a reduced dose according to creatinine clearance.

Children's dosage

○ Children 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 (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/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/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. 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 (e.g., peritoneal, endocardial, pulmonary, and urinary tract infections): Administer 6-12 mg/kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of body weight of this medicine on the first day, followed by 6 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/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/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 degree of renal impairment, using the same criteria as for adults with renal impairment. When administering a dose below 10 mg, give the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. Firstly, patients who have had allergic reactions to this drug or other azole antifungal agents should not use it. Women who are pregnant or may become pregnant, as well as nursing mothers should also not take this medication. Additionally, concomitant use with certain medications can lead to serious side effects and should be avoided. For example, it should not be taken with drugs that may affect the heart such as terfenadine, cisapride, astemizole, erythromycin, etc. This drug contains lactose, so it is also advisable for patients with lactose intolerance not to take it. Patients with impaired kidney or liver function, heart disease, or a risk of arrhythmia should be particularly cautious when using this drug. This drug may worsen liver function and pose a risk of cardiac disturbances or electrolyte imbalance. Moreover, dosage adjustments or monitoring may be required depending on other medications taken with this drug. This medication is generally well tolerated; however, rare side effects may occur, including blood disorders, allergic reactions, liver dysfunction, skin rash, digestive disorders, headaches, dizziness, etc. It is important to regularly monitor liver function during treatment as liver function may deteriorate. It is recommended not to use this medication during pregnancy, and women who may become pregnant should use effective contraception during treatment and for about one month after the last dose. It is also safest for nursing mothers not to take this drug. For children under 6 months of age, safety has not been established, so it should be administered cautiously only in special cases. Care should be taken when driving or operating machinery as dizziness or seizures may occur after taking this medication. In case of overdose, hallucinations or unusual behavior may occur, and immediate medical attention should be sought. This medication is mainly excreted through urine, so increasing fluid intake may facilitate excretion, and if necessary, blood dialysis can be used to reduce drug concentration.

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, flatulence, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased 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, psychotic behavior

This medication should be stored in a tightly sealed container to prevent air ingress, at room temperature between 1 degree and 30 degrees Celsius. Proper storage will maintain the efficacy of the drug and prevent degradation.

Appearance

Hard capsule filled with white to light brown contents, upper part pale blue, lower part white

Package unit

30 capsules/bottle, 100 capsules/bottle