Dina Can Capsule (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. Vulvovaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg of this product 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 product once daily for 14 days. Local disinfection of dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose is 50 mg of this product 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 of this product once 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this product once on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment is determined by clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed primary treatment, administer 200 mg of this product 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 product 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 bone marrow transplant recipients with severe or prolonged neutropenia. In these patients, administer 400 mg once daily beginning 5-6 days before the anticipated onset of neutropenia and continue for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or greater. Onychomycosis of the fingernails or toenails: 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 usually take 6-12 months; growth rates may vary by individual and age. Even after successful long-term treatment, the fingernails or toenails may occasionally remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this product 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. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: No dosage adjustment is required for a single dose. If multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as below. Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, reduce the dose according to creatinine clearance.

Children's dosage

Pediatric dose equivalent to an adult dose of 100 mg: 3 mg/kg Pediatric dose equivalent to an adult dose of 200 mg: 6 mg/kg Pediatric dose equivalent to an adult dose of 400 mg: 12 mg/kg The pediatric dose should not exceed 400 mg. Safety and efficacy 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 starting 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 starting the next day. The dose may be increased 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 the 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 starting 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: After the patient has completed primary treatment, administer 6 mg/kg body weight once daily. Pediatric patients with renal impairment: Extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment. When administering a dose below 10 mg, give the 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. For example, patients who are allergic to this drug or related medications, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Additionally, caution is required as taking this medicine together with certain other medications can cause serious side effects. In particular, it should not be used in conjunction with medications that can affect heart rhythm, and lactose intolerant patients should avoid using this drug due to the lactose content. When taking this medication, it should be administered carefully to patients with a history of allergies or issues with kidney or liver function, as there is a risk of liver dysfunction or cardiac arrhythmias. Generally, this drug has fewer side effects, but in rare cases, blood abnormalities, liver damage, skin rashes, cardiac arrhythmias, and gastrointestinal disturbances may occur. Hence, any abnormal symptoms should be reported to the medical staff immediately. During medication, it is advisable to have regular blood tests along with assessments of liver and kidney function. In patients with severe illnesses, the administration of this drug should be reconsidered in cases of elevated liver enzyme levels. Due to the risk of cardiac-related side effects, special caution is required when this drug is taken by patients with hypokalemia or heart failure. This medication can interact with various drugs; hence, it's crucial to inform doctors or pharmacists if other medications are being taken, and if necessary, dosage adjustments or monitoring might be required. Pregnant or nursing women should not take this medication, and women of childbearing age must ensure effective contraception during and for a certain period after taking this medication. Safety in children, particularly infants under 6 months of age, has not been established; thus, it should only be used cautiously when absolutely necessary. Dizziness or seizures may occur while driving or operating machinery; caution is advised. In case of overdose, hallucinations or unusual behavior may appear, and medical assistance should be sought immediately. This medication is primarily excreted through urine, so treatments that promote elimination may be beneficial.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremors, 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, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, excessive sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reactions accompanied by eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture, and it is safe to store at room temperatures between 1 degree and 30 degrees Celsius. By storing it this way, the drug's effectiveness can be maintained and degradation can be prevented.

Appearance

A hard capsule filled with white powder, sky-blue upper part, and white lower part

Package unit

30 capsules/PE bottle, 100 capsules/PE bottle