Hyunazol Capsule 50mg (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 a single oral dose of fluconazole 150 mg Oropharyngeal candidiasis: Usually administer 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral pain caused by dentures): Usually administer 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): Usually administer 50 mg of this medicine 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 (peritoneum, endocardium, lungs, urinary tract, etc.): Usually administer 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: Usually administer 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 usually 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. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In such patients, administer 400 mg beginning 5-6 days before the anticipated 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 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 take 6-12 months; growth rates may vary between individuals and according to age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: Usually administer 50 mg of this medicine once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks, depending on its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, administer the usual adult dose. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for 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 (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 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 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 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. Treat for at least 3 weeks and for at least 2 weeks after symptoms have resolved. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, urinary tract, 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 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. For children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment, based on the severity of renal impairment. When administering doses below 10 mg, give the syrup orally or the injection intravenously according to the child's clinical condition to ensure accurate dosing.

This medication should not be administered to certain patients. For example, patients allergic to this medication or similar drugs, pregnant or lactating women, and patients taking certain heart medications should not use this drug. Additionally, patients with kidney or liver dysfunction, heart disease, or at risk of arrhythmias need special precautions when using this drug. This medication can affect the liver and kidneys, so regular monitoring may be required. This medication is generally well tolerated, but rarely can cause abnormalities in blood, liver, or kidney function, along with skin rash or allergic reactions. Gastrointestinal symptoms like headaches, abdominal pain, diarrhea, and vomiting may occur during the use of this drug, and rare cases of cardiac arrhythmias may also need monitoring. This medication can interact with various other medications, so if you are taking other medications, you must inform your healthcare provider, especially when used with heart medications, anticoagulants, anticonvulsants, or immunosuppressants, and follow their instructions. This medication should not be used during pregnancy, and women who could become pregnant should use effective contraception during and for a certain period after taking this drug. It is also advisable for nursing mothers not to take this medication. Safety for children, particularly infants under 6 months of age, has not been established, so it should only be used when absolutely necessary. When driving or operating machinery, precautions should be taken as dizziness or seizures may occur after taking this medication. If this medication is taken in excess, symptoms such as hallucinations or abnormal behavior may appear, so immediate contact with medical facilities is required for appropriate treatment. This drug is primarily excreted in urine, so treatment may involve promoting urination in the case of overdose.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsade 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, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, itch, 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, weakness, fever, adrenal insufficiency, hallucinations, combative behavior

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture. It is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a white lower part filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle