Medication info
Flustacapsule (Fluconazole)

Flustacapsule (Fluconazole)

Prescription medicationHard capsule
Ingredient · strength
Fluconazole›50mg / 1 capsule
Manufacturer / importer
Bionex Co., Ltd.
Appearance
A capsule with a pale blue upper part and a white lower part filled with white to off-white powder.
Packaging
30,100 capsules/bottle
Approval status
Active

MFDS item code 201400706 · Approved 2014.02.17 · Insurance code 643103750

Summary

Main use
Treatment of candidiasis and cryptococcosis, prevention of fungal infections and recurrence, and treatment of cutaneous 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. Vulvovaginal candidiasis: Administer 150 mg of fluconazole as a single oral 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. Local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be 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 should be determined according to clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After the patient has completed all primary treatment, administer 200 mg once daily indefinitely. Prevention of fungal infections: Administer 50-400 mg 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 patients with severe neutropenia or an expected prolonged period of neutropenia, as in bone marrow transplantation. In such 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. Onychomycosis: Administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It generally takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rate may vary from person to person and with age. Dermatophyte infections, including tinea pedis (athlete's foot), 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, tinea pedis may require treatment for 6 weeks, depending on the course of the infection. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Older adults: Use the usual adult dose if renal function is normal. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or increase 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 on hemodialysis. 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. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent relapse. Esophageal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Administer 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.): 6-12 mg/kg of body weight once daily. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, followed by 6 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Administer for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After completion of all primary treatment, administer 6 mg/kg of body weight once daily. Infants younger than 6 months: Safety and efficacy have not been established. Pediatric patients with renal impairment: Increase the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, use oral syrup or intravenous injection, according to the child's clinical condition, to ensure accurate dosing.

Ingredients

Manufacturer
Bionex Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cryptococcosis, prevention of fungal infections and recurrence, and treatment of cutaneous fungal infections

  • Acute vaginal candidiasis
  • recurrent vaginal candidiasis
  • oral pharyngeal infection
  • esophageal infection
  • non-invasive bronchopulmonary infection
  • candiduria
  • cutaneous candidiasis
  • chronic atrophic oral candidiasis
  • oral pain
  • candidemia
  • disseminated candidiasis
  • invasive candidal infection
View approved original text

This medication is used for the treatment of acute or recurrent vaginal candidiasis, as well as mucosal candidiasis in patients with normal immune function and those with compromised immunity, including oral, pharyngeal, esophageal, and non-invasive bronchopulmonary infections. It is also effective against candidemia, disseminated candidiasis, and invasive candidal infections that affect the peritoneum, endocardium, lungs, and urinary tract. In immunocompromised patients, it is utilized for the treatment of cryptococcal meningitis and cryptococcosis affecting various body parts, and for maintenance therapy to prevent recurrent cryptococcosis in AIDS patients. Moreover, it is suitable for the prevention of fungal infections in patients with neutropenia caused by chemotherapy, radiotherapy, and bone marrow transplantation. Lastly, it is effective for the treatment of various skin fungal infections such as toenail and fingernail onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. Therefore, this medication is used for the treatment and prevention of 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. Vulvovaginal candidiasis: Administer 150 mg of fluconazole as a single oral 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. Local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be 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 should be determined according to clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After the patient has completed all primary treatment, administer 200 mg once daily indefinitely. Prevention of fungal infections: Administer 50-400 mg 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 patients with severe neutropenia or an expected prolonged period of neutropenia, as in bone marrow transplantation. In such 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. Onychomycosis: Administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It generally takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rate may vary from person to person and with age. Dermatophyte infections, including tinea pedis (athlete's foot), 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, tinea pedis may require treatment for 6 weeks, depending on the course of the infection. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Older adults: Use the usual adult dose if renal function is normal. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or increase 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 on hemodialysis. 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. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent relapse. Esophageal candidiasis: 6 mg/kg of body weight on the first day, followed by 3 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Administer 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.): 6-12 mg/kg of body weight once daily. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, followed by 6 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of body weight once daily. Administer for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of relapse of cryptococcal meningitis in patients with AIDS: After completion of all primary treatment, administer 6 mg/kg of body weight once daily. Infants younger than 6 months: Safety and efficacy have not been established. Pediatric patients with renal impairment: Increase the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, use oral syrup or intravenous injection, according to the child's clinical condition, to ensure accurate dosing.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to this medication or other azole medications, pregnant women, women who may become pregnant, and nursing mothers. Additionally, it should not be combined with certain medications as it may lead to serious side effects. When using this medication, it must be administered more cautiously to patients with kidney or liver function problems, heart disease, or electrolyte imbalances. Caution is also required if there is a history of drug hypersensitivity. This medication can worsen liver function and may cause arrhythmias, so patients with related diseases should use it under strict physician supervision. While this medication is generally well tolerated, there can be rare adverse reactions affecting blood, liver, kidneys, skin, etc. Common symptoms include headache, abdominal pain, diarrhea, and vomiting, and in severe cases, life-threatening side effects such as liver toxicity or cardiac arrhythmia may occur; thus, patients should consult healthcare providers immediately if abnormal symptoms arise. Patients using this medication long-term or those with severe illnesses should undergo regular blood tests, liver function tests, and kidney function tests, and reevaluate the administration if liver enzyme levels increase. Patients with AIDS or cancer should be particularly vigilant regarding skin adverse reactions. This medication has numerous drug interactions; therefore, patients taking other medications should inform their doctors or pharmacists. When combined with some medications, there may be risks of arrhythmias, increased bleeding risk, and changes in drug concentration, necessitating dosage adjustments or monitoring depending on the concurrently used medications. It is advisable not to take this medication during pregnancy, especially in the early stages, as it may pose a risk of congenital abnormalities to the fetus. During breastfeeding, this medication can excrete into breast milk and affect the infant, so administration should be avoided. In infants under 6 months of age, safety has not been established, and it should only be used very carefully when absolutely necessary. There may be a risk of dizziness or seizures after taking this medication during driving or operating machinery, so caution is needed. In excessive doses, symptoms such as hallucinations or paranoia may appear, and in such cases, immediate medical attention is required. This medication is primarily excreted through urine, so adequate hydration and, if necessary, blood dialysis can help with drug removal.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, sensory disturbance, taste disturbance, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated 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, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

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

Storage

This medication should be stored in a tightly closed container to prevent air exposure and should be kept at room temperature between 1°C and 30°C. This helps maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

A capsule with a pale blue upper part and a white lower part filled with white to off-white powder.

Package unit

30,100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.