Medication info
Flucoazole Capsule 150 mg (Fluconazole)

Flucoazole Capsule 150 mg (Fluconazole)

Prescription medicationOral
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
Gunil Biopharm Co., Ltd.
Appearance
Capsule filled with white powder, the upper part is dark blue and the lower part is light blue.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201908482 · Approved 2019.12.17 · Insurance code 073000840

Summary

Main use
Treatment of candidiasis, cryptococcosis, and cutaneous fungal infections; suppression of recurrence; prevention of fungal infections
Who takes it
Adults
Adult dose
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 (tablets, capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400mg once on the first day, followed from the next day by 200mg once daily; the dose may be increased to up to 400mg 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 of this drug is 400mg once on the first day, followed from the next day by 200 ~ 400mg once daily. The duration of treatment is determined by clinical and mycological response, but treatment should generally be continued for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200mg of this drug once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50~ 400mg of this drug once daily, depending on the patient's degree of risk of developing a fungal infection. A dose of 400mg once daily is recommended for patients at very high risk of systemic fungal infections, such as bone marrow transplant recipients with severe neutropenia or an expected prolonged period of neutropenia. In these patients, administer 400mg starting 5-6 days before neutropenia is expected to begin, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000cells/mm3 or more. For onychomycosis, administer 150 mg once weekly; continue treatment 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 approximately 6-12 months; growth rates may vary among individuals 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: The usual dose of this drug 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 its course. For tinea versicolor, administer 50mg once daily for 2-4 weeks. Elderly patients: When renal function is normal, the usual adult dose is 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 dose adjustment is necessary for a single dose; however, if multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the following day as follows. 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 regular dialysis: 100% of the usual dose after each hemodialysis session Patients receiving 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.

Ingredients

Manufacturer
Gunil Biopharm Co., Ltd.

Efficacy & effects

Treatment of candidiasis, cryptococcosis, and cutaneous fungal infections; suppression of recurrence; prevention of fungal infections

  • Acute vulvovaginal candidiasis
  • recurrent vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • systemic candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • neutropenia
  • fungal infections
  • onychomycosis
  • athlete's foot
  • tinea corporis
View approved original text

This medication is effective in treating acute or recurrent vulvovaginal candidiasis and various invasive candidal infections such as candidemia and disseminated candidiasis. It is also used to treat cryptococcal meningitis and cryptococcal infections in various parts of the body, which occur in immunocompromised patients. It is helpful for maintenance therapy to prevent the recurrence of cryptococcal infections in patients with AIDS. Additionally, it is used as a prophylactic measure for patients at high risk of fungal infections due to immunocompromised status. It is effective in treating a wide range of fungal infections affecting the skin and nails, including tinea pedis, tinea corporis, and vulvovaginal candidiasis. This helps systematically treat and prevent fungal infections.

How to take

Adult dose

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 (tablets, capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400mg once on the first day, followed from the next day by 200mg once daily; the dose may be increased to up to 400mg 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 of this drug is 400mg once on the first day, followed from the next day by 200 ~ 400mg once daily. The duration of treatment is determined by clinical and mycological response, but treatment should generally be continued for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200mg of this drug once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50~ 400mg of this drug once daily, depending on the patient's degree of risk of developing a fungal infection. A dose of 400mg once daily is recommended for patients at very high risk of systemic fungal infections, such as bone marrow transplant recipients with severe neutropenia or an expected prolonged period of neutropenia. In these patients, administer 400mg starting 5-6 days before neutropenia is expected to begin, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000cells/mm3 or more. For onychomycosis, administer 150 mg once weekly; continue treatment 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 approximately 6-12 months; growth rates may vary among individuals 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: The usual dose of this drug 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 its course. For tinea versicolor, administer 50mg once daily for 2-4 weeks. Elderly patients: When renal function is normal, the usual adult dose is 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 dose adjustment is necessary for a single dose; however, if multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the following day as follows. 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 regular dialysis: 100% of the usual dose after each hemodialysis session Patients receiving 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.

Precautions

This medication should not be taken by certain patients. First, patients who have had an allergic reaction to this medication or other azole medications should not take it. Second, pregnant women, women who may become pregnant, and nursing women should not take this medication. Third, patients taking certain medications, such as terfenadine, cisapride, astemizole, or erythromycin, should not take this medication together, as it may cause heart problems. Fourth, this medication contains lactose, so patients with lactose intolerance or hereditary conditions affecting glucose-galactose absorption should not take it. This medication should be used cautiously in patients with kidney or liver function issues, heart disease, or electrolyte disorders that may lead to arrhythmias. Also, when taking it with other drugs, caution should be exercised regarding drug interactions, especially with drugs metabolized by CYP enzymes, and the patient's condition should be closely monitored. In general, this medication has good tolerability, but rare side effects such as blood dyscrasias, allergic reactions, liver dysfunction, cardiac arrhythmias, gastrointestinal issues, skin rashes may occur. It is particularly important to regularly monitor liver function tests during treatment, as liver function may worsen. Taking this medication during pregnancy increases the risk of congenital malformations or miscarriage, so pregnant women or women planning to become pregnant should avoid it. Nursing mothers should also avoid it as it may be excreted in breast milk. Safety in infants, especially those under 6 months old, has not been established, so it should be used cautiously only when necessary. Dizziness or seizures may occur upon taking this medication while driving or operating machinery, so caution is advised. In case of overdose, hallucinations or abnormal behavior may occur, and prompt medical attention should be sought for appropriate treatment. This medication is primarily excreted unchanged in urine, so adequate hydration is important, and in necessary cases, the drug can be removed through hemodialysis.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, 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 reactions associated with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, 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 sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. Doing so will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Capsule filled with white powder, the upper part is dark blue and the lower part is light blue.

Package unit

30 capsules/bottle, 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.