Miconazole 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 oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg of this drug 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 vaginal candidiasis): The usual dose is 50 mg of this drug 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 drug as a single dose on the first day, followed by 200 mg once daily from the next day; the dose may be increased to up 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 is 400 mg of this drug 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. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed initial treatment, administer 200 mg of this drug once daily indefinitely. Prevention of fungal infections: Administer 50-400 mg of this drug once daily according to the patient's risk of developing a 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 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. Onychomycosis: Administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take approximately 6-12 months; growth rates may vary by individual and age. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg of this drug 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. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Elderly patients with normal renal function generally receive 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: No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day, then from the next day administer 100% of the usual dose if creatinine clearance is > 50 mL/min, 50% of the usual dose if ≤50 (not on dialysis), and 100% of the usual dose after each hemodialysis session in patients receiving hemodialysis. Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, 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 in infants younger than 6 months have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. To prevent recurrence, treatment should continue for at least 2 weeks. Esophageal candidiasis: Administer 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to up to 12 mg/kg body weight once daily according to 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 body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed initial treatment, administer 6 mg/kg body weight once daily. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment, depending on the degree of renal impairment. When administering a dose of less than 10 mg, give the oral syrup or intravenous injection to ensure accurate dosing, according to the child's clinical condition.

This medication should not be used in certain patients. For example, it should not be administered to individuals allergic to this medication or similar medications or to pregnant or breastfeeding women. Moreover, patients taking certain medications should avoid using this medication concurrently. For instance, it can be risky if used in combination with medications that may affect the heart or specific antibiotics. Patients with genetic conditions such as lactose intolerance should not take this medication. Caution should be exercised when administering this medication to patients with impaired kidney or liver function, heart disease, or a history of drug allergies. This medication can impact liver function, so regular monitoring of liver and kidney function tests is recommended during treatment. Special precautions should be taken for patients with heart disease, as there could be potential heart rhythm abnormalities. Additionally, this medication can interact with several other drugs, thus consultation with a physician or pharmacist is necessary if other medications are being taken. Women who are pregnant or of childbearing age should practice effective contraception while on this medication and for some time after stopping it, and it is advisable for pregnant women to avoid this medication. Breastfeeding mothers are also advised against taking this medication. The safety of this medication for young children, particularly infants under 6 months of age, has not been established; it should only be administered when necessary. Dizziness or seizures may occur, so caution is needed while driving or operating machinery. In case of overdose, hallucinations or unusual behaviors may manifest, and immediate medical attention should be sought. This medication is mainly excreted through urine; therefore, in case of overdose, blood dialysis can reduce the drug concentration.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremor, 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, hepatocellular 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, weakness, fever, adrenal insufficiency, hallucinations, aggressive behavior

This medication may be sensitive to air or moisture; hence, it should be stored in a sealed container. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Capsule with a blue upper part filled with white powder and a white lower part

Package unit

30 capsules/bottle, 100 capsules/bottle