Medication info
Il Yang Bio Fluconazole Capsule

Il Yang Bio Fluconazole Capsule

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluconazole›50mg / 1 capsule
Manufacturer / importer
Il Yang Biopharm Co., Ltd.
Appearance
A hard capsule with a blue upper part and white lower part, containing a white to off-white powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 200503787 · Notified 2005.12.30

Summary

Main use
Treatment and prevention of recurrence of candidiasis, dermatomycosis, and cryptococcosis; prevention of fungal infections
Who uses it
Adults · Children
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 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 caused by dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 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 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 should be determined according to the clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 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 the 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 once daily indefinitely after the patient has completed all primary 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 according to the patient's degree of risk for 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 expected prolonged period of neutropenia, as in bone marrow transplantation. In these 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 increases to 1,000 cells/mm3 or higher. For onychomycosis of the fingernails and toenails, administer 150 mg once weekly until the nails regrow (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term therapy. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose 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 of the infection. For tinea versicolor, administer 50 mg 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 drug is excreted mainly in the urine unchanged. No dosage adjustment is needed for a single dose. If multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as follows: Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On non-dialysis days, the dose should be reduced 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 drug in infants younger than 6 months 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 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 once daily. The duration of treatment should be determined according to the 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 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/kg once daily after the patient has completed all primary treatment. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the same criteria used for adults with renal impairment. When administering doses below 10 mg, oral syrup or intravenous injection should be used, depending on the child's clinical condition, to ensure accurate dosing.

Ingredients

Manufacturer
Il Yang Biopharm Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of candidiasis, dermatomycosis, and cryptococcosis; prevention of fungal infections

  • Acute vaginal candidiasis
  • recurrent vaginal candidiasis
  • oropharyngeal infection
  • esophageal infection
  • non-invasive bronchopulmonary infection
  • candiduria
  • skin mucosal infections
  • chronic atrophic oral candidiasis
  • oral pain due to dentures
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
View approved original text

This medication is used to treat acute or recurrent vaginal candidiasis as well as various forms of candidiasis, including oral thrush, esophageal candidiasis, and skin mucosal infections. It is also effective for severe systemic candidal infections such as candidemia. It is used for the treatment and relapse prevention of cryptococcal meningitis and other cryptococcosis in immunocompromised patients. It may also be used for the prevention of fungal infections in patients at high risk due to cytotoxic chemotherapy or radiation therapy. This medication is effective for dermatophyte infections such as onychomycosis, tinea pedis, tinea corporis, and tinea cruris. Thus, it is widely used for the treatment and prevention of the various fungal infections.

Dosage and Administration

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 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 caused by dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 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 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 should be determined according to the clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 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 the 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 once daily indefinitely after the patient has completed all primary 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 according to the patient's degree of risk for 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 expected prolonged period of neutropenia, as in bone marrow transplantation. In these 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 increases to 1,000 cells/mm3 or higher. For onychomycosis of the fingernails and toenails, administer 150 mg once weekly until the nails regrow (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term therapy. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose 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 of the infection. For tinea versicolor, administer 50 mg 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 drug is excreted mainly in the urine unchanged. No dosage adjustment is needed for a single dose. If multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as follows: Creatinine clearance > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On non-dialysis days, the dose should be reduced 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 drug in infants younger than 6 months 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 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 once daily. The duration of treatment should be determined according to the 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 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/kg once daily after the patient has completed all primary treatment. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the same criteria used for adults with renal impairment. When administering doses below 10 mg, oral syrup or intravenous injection should be used, depending on the child's clinical condition, to ensure accurate dosing.

Precautions

This medication should not be administered to certain patients. For instance, it may be dangerous for patients allergic to this medication or similar drugs, women who are pregnant or breastfeeding, and patients taking certain other medications. Additionally, patients with genetic issues such as lactose intolerance should avoid taking this medication. Patients with kidney or liver dysfunction, heart diseases, or at risk for arrhythmia need to exercise special caution while using this medication as it can affect heart rhythm, requiring close monitoring of their cardiac health. This medication can interact with various drugs, so patients taking other medications must inform their doctor or pharmacist, as dose adjustments or monitoring may be necessary. Generally, this medication is well-tolerated, but rare side effects such as blood abnormalities, liver dysfunction, skin rashes, cardiac arrhythmias, gastrointestinal issues, etc. can occur. While taking this medication, it is important to regularly check liver and kidney function, blood tests, and cardiac conditions. Pregnant women or those who may become pregnant should avoid taking this medication due to potential fetal effects, and should practice contraception for some time after discontinuation. Breastfeeding women should also consider stopping breastfeeding or using alternative medications, as this drug may pass into breast milk. The safety of this medication in children, particularly infants under 6 months old, has not been established, hence it should only be used in exceptional cases. This medication may occasionally cause dizziness or seizures; therefore, caution is needed while driving or operating machinery. In case of an overdose, symptoms like hallucinations or abnormal behavior may occur, making it imperative to seek immediate medical assistance. Gastric lavage or symptomatic treatment may be performed if necessary, and hemodialysis can help reduce this medication's concentration in the body.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, 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, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, aggressive behavior

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to prevent air ingress, and keep it at room temperature, ideally between 1 to 30 degrees Celsius. By doing so, the medication's efficacy can be well maintained.

Appearance and packaging

Appearance

A hard capsule with a blue upper part and white lower part, containing a white to off-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.