Difnazol 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 fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose 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 is 50 mg once daily for 14 days, along with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, 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. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg 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 is determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg once 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 be given for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg 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 once daily, depending on the patient's risk of fungal infection. For patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation with severe or prolonged neutropenia expected, 400 mg once daily is recommended. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia, and continue 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 grown back (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, 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. Skin fungal infections, including tinea pedis, tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of tinea pedis may need to continue for 6 weeks, depending on the course of the condition. 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 in the urine unchanged. No dose adjustment is necessary for a single dose, but if 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 on 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

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 in infants under 6 months of age have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg 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 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. 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.): Administer 6-12 mg/kg once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg 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 all initial treatment. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the severity of renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, as appropriate to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals who are allergic to this medication or similar drugs, pregnant women, or breastfeeding women should not take it. Additionally, it may be dangerous to take it with certain medications, so if you are taking any other drugs, be sure to inform your doctor or pharmacist. For example, it is prohibited to take it with medications that affect heart rhythm or certain antibiotics and antihistamines. Patients with genetic metabolic disorders such as lactose intolerance should also refrain from using this medication. This medication should be administered with caution in patients with impaired kidney or liver function, heart disease, or electrolyte imbalances. Such patients may need regular testing during treatment. It is recommended to perform blood tests before starting treatment since this medication may affect blood, liver, and kidney functions. During the course of taking this medication, side effects like headaches, abdominal pain, diarrhea, and rashes may occur, and in rare cases severe skin reactions or liver damage can occur. Pregnant women should avoid this medication due to potential harm to the fetus, and women of childbearing age should use effective contraception during the treatment and for a certain period afterward. Breastfeeding women should also avoid this medication as it can be excreted in breast milk and may affect the baby. The safety of this medication in children, especially infants under 6 months of age, has not been fully established, so it should only be used with caution when absolutely necessary. Care should be taken when driving or operating machinery, as dizziness or seizures may occur. Overdosage may lead to symptoms of mental disturbance or changes in behavior, in which case immediate medical attention is required.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, convulsion, dizziness, sensory abnormalities, taste disturbances, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular injury, 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, malaise, asthenia, fever, adrenal insufficiency, hallucinations, manic behavior

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its efficacy.

Appearance

A hard capsule with blue upper part and white lower part containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle