Miconazole Capsule (Fluconazole)

Adult dosage

Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose of this medicine is 50mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose of this medicine is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) 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. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, urinary tract, 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400mg as a single dose on the first day, followed by 200 ~ 400mg 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. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed initial treatment. 6. 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 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. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete's foot (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, athlete's foot may require treatment for 6 weeks depending on the course. For tinea versicolor, administer 50mg once daily for 2-4 weeks. Elderly patients If renal function is normal, the usual adult dose may be administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose, but when multiple doses are required, administer the usual dose on the first day only 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 receiving 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

Pediatric dose reference: pediatric dose of 3 mg/kg corresponds to an adult dose of 100 mg Pediatric dose reference: pediatric dose of 6 mg/kg corresponds to an adult dose of 200 mg Pediatric dose reference: pediatric dose of 12 mg/kg corresponds to an adult dose of 400 mg The pediatric dose should not exceed 400 mg. Infants younger than 6 months: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis – Administer 6 mg/kg of this medicine 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. 2. Esophageal candidiasis – Administer 6 mg/kg of this medicine 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 according to the patient's response. Treatment should continue for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, urinary tract, etc.) – Administer 6-12 mg/kg once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis – Administer 12 mg/kg of this medicine 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 according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6mg/kg once daily after the patient has completed initial treatment. 6. Children with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as adults with renal impairment. When administering doses of less than 10mg, an oral syrup or intravenous injection should be used according to the child's clinical condition to ensure accurate dosing.

This medication should not be used in certain patients. Patients allergic to this drug or similar components, those who are pregnant or potentially pregnant, and breastfeeding women should not take this medication. Additionally, serious side effects may occur if taken with certain drugs, so patients must consult with their doctor or pharmacist about any current medications. This drug contains lactose, so patients with lactose intolerance or related genetic diseases should avoid this medication. Patients with kidney or liver function issues should use this medication with caution, as liver function may deteriorate, necessitating regular tests. Patients with heart disease or electrolyte imbalances should also be cautious, as arrhythmias and other heart-related abnormalities may occur. This drug has many interactions with other medications, so dosage adjustments or monitoring may be necessary depending on the medications taken concurrently. Special caution should be exercised if taking drugs that may affect the heart or drugs metabolized in the liver. While taking this medication, rare abnormalities may occur in blood, liver, or kidney function, hence regular testing and observation for symptoms is crucial. This drug should be avoided during pregnancy, and women planning for pregnancy should implement effective contraception for one month during and after taking this drug. Breastfeeding women are also advised against taking this medication. The safety for children, especially infants under 6 months old, has not been established, thus it should be used cautiously only when necessary. Patients may occasionally experience dizziness or seizures while taking this medication, so caution is advised when driving or operating machinery. In case of overdose, serious neuropsychiatric symptoms may occur, so the prescribed dosage should be strictly adhered to, and immediate medical attention should be sought in cases of overdose.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, xerostomia, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular injury, rash, pruritus, 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 (DRESS), myalgia, fatigue, malaise, weakness, fever, hallucinations, dysphoric behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle