Dihurex 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. Vaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. Oropharyngeal candidiasis: The usual dose is 50 mg of this medication 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 medication once daily for 14 days. Local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this medication 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 medication 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 depending on the patient's response. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medication 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 medication once daily indefinitely after the patient has completed 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 medication 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 those with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. For onychomycosis, 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 take 6-12 months; growth rates may vary by individual and age. Even after successful treatment with long-term administration, fingernails or toenails may sometimes remain damaged. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medication once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. Use the usual adult dose in patients with normal renal function. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. This medication is excreted mainly in the urine unchanged. No dose adjustment is necessary when administering a single dose. If multiple doses are required, administer the usual dose only on the first day, then adjust the dose as follows from the next day: Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤50 (not on dialysis): 50% of the usual dose Patients undergoing hemodialysis: 100% of the usual dose after each hemodialysis session Patients undergoing 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

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 medication have not been established in infants younger than 6 months. Oropharyngeal candidiasis: Administer 6 mg/kg of this medication on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medication on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on the patient's response. Administer 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.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medication on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily depending on 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/kg once daily after the patient has completed 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, administer the oral syrup or give the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals with allergies to this drug or similar components, and pregnant or breastfeeding women should avoid its use. Patients with heart disease or impaired kidney and liver function need to exercise special caution when using this drug. It can affect heart rhythm, thereby increasing the risk of arrhythmias. This drug has a high potential for interactions with other medications, so it is crucial to consult with a doctor or pharmacist if one is taking other medications. Taking it alongside certain drugs may worsen side effects or alter its efficacy. Women who are pregnant or of childbearing potential should employ effective contraception during treatment and for a period after administration. This drug may be harmful to the fetus, thus pregnant women should avoid its use. Breastfeeding women should also refrain from using this medication as it may pass to the baby. The safety of this drug in children, especially infants under 6 months, is not well established; it should only be used when necessary and under a doctor's discretion. During treatment, dizziness or seizures may occasionally occur; therefore, caution is advised when driving or operating machinery. If this drug is taken in excess, hallucinations or abnormal behaviors may occur, necessitating immediate medical attention and appropriate treatments such as gastric lavage, if required. It is safest to use this medication while regularly monitoring kidney and liver functions and conducting blood tests.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbance, taste disturbance, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver 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 swelling, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, behavioral disturbances

This drug should be stored in a sealed container that prevents air exposure, and it is best kept at room temperature between 1 degree to 30 degrees Celsius. This will help maintain the medication's efficacy and safety for a longer period.

Appearance

Hard capsule filled with white powder; upper light green and lower yellowish.

Package unit

30 capsules/bottle, 100 capsules/bottle