Dirucan Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of 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. Local disinfection of the dentures should also be performed. 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, and urinary tract infections, etc.): The usual dose of this medicine is 400 mg as a single dose on the first day, followed by 200 mg once daily from the next day. The dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment is 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 from 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. 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 initial 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. For patients at very high risk of systemic fungal infection, such as those with severe neutropenia or an anticipated prolonged period of neutropenia following bone marrow transplantation, 400 mg once daily is recommended. For these patients, administer 400 mg starting 5-6 days before the onset of neutropenia is expected, and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the nails have regrown (until new, uninfected nails have grown). Fingernails generally take 3-6 months to regrow, and toenails take approximately 6-12 months. Growth rates may vary by age and from person to person. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis, tinea corporis, 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, treatment of tinea pedis may be required for 6 weeks, depending on the course of the disease. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. In 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 medicine is excreted mainly unchanged in the urine. No dose adjustment is necessary for a single dose; however, for multiple doses, 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 non-dialysis days, 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 medicine in infants younger than 6 months have not been established (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg per kg of body weight of this medicine on the first day, followed by 3 mg per kg of body weight once daily from the next day. The dose may be increased to 12 mg per kg of body weight once daily according to the patient's response. Treatment should continue 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, and urinary tract infections, etc.): Administer 6-12 mg per kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg per kg of body weight of this medicine on the first day, followed by 6 mg per kg of body weight once daily from the next day. The dose may be increased to 12 mg per kg of body weight once daily according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. 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 all initial treatment. In children with renal impairment, extend the dosing interval and reduce the dose according to 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. First, patients who are allergic to this drug or similar medications should not use it. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should not take this medication. Additionally, patients taking certain medications that may pose a risk to the heart should not use it. This medication contains lactose, and patients with lactose intolerance or related genetic disorders should not take it. Patients with a history of allergies, or those with kidney or liver function issues, or those at risk of arrhythmias due to heart disease or electrolyte abnormalities should use this drug with caution. Careful monitoring and dose adjustments may be necessary when used with specific medications. This medication inhibits enzymes involved in drug metabolism in the liver, therefore careful attention is required for potential drug interactions. It is generally well tolerated, but it can occasionally affect blood, liver, and kidney functions. Gastrointestinal symptoms such as headache, abdominal pain, diarrhea, nausea, vomiting, and dyspepsia, as well as skin rashes and itching, may occur. Severe side effects such as liver damage or cardiac arrhythmias have also been reported. Regular blood tests and assessments of liver and kidney function are recommended during treatment. Particularly, if liver enzyme levels increase, reevaluation of the medication is necessary. Patients with heart disease or electrolyte abnormalities require cardiac monitoring. Since this medication has many interactions with other drugs, it is important to consult a doctor or pharmacist if taking any additional medications. The risk of cardiac arrhythmias may increase when taken with some drugs, so concurrent use should be avoided. It is safest not to take this medication during pregnancy, and women of childbearing age should ensure effective contraception during and after the course of treatment. The safety of this medication in infants under 6 months has not been adequately established, and it should only be used with caution when necessary. Caution is advised in driving or operating machinery, as dizziness or seizures may occur. In case of overdose, hallucinations or unusual behavior may be observed, and appropriate treatment should be sought immediately at a hospital. This medication is primarily excreted through urine, so adequate hydration and hemodialysis if necessary can assist with excretion.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, ALT elevation, AST elevation, increased serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular 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 may be sensitive to air and moisture, so it should be stored in a tightly closed container. Avoid extremely hot or cold locations, and it is best to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

A blue hard capsule with white powder inside.

Package unit

30 capsules/bottle, 100 capsules/bottle