Medication info
Fluco Tablet 150 mg (Fluconazole)

Fluco Tablet 150 mg (Fluconazole)

Prescription medicationTabletOral
Ingredient · strength
Fluconazole›150mg / 1 tablet
Manufacturer / importer
IYON Pharmaceutical Co., Ltd.
Appearance
Pink rectangular tablet
Packaging
4 tablets (4 tablets/PTP x 1), 30 tablets/bottle
Approval status
Active

MFDS item code 200607665 · Notified 2006.10.13 · Insurance code 658601870

Summary

Main use
Treatment of candidiasis and cryptococcosis, treatment of dermatomycosis, and prevention of fungal infections and recurrence
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. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400 mg once 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 clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once 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 be continued for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily, depending on the patient’s level 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. 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 has increased to 1,000 cells/mm3 or more. 6. For 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 new toenail to grow; growth rate may vary by individual and age. In some cases, the nails may remain damaged after successful treatment with long-term administration. For cutaneous fungal 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, treatment of athlete’s foot may be needed for 6 weeks depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If 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 when it is administered as a single dose. However, when 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 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 non-dialysis days, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
IYON Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is primarily used to treat acute or recurrent vulvovaginal candidiasis. It is also effective against systemic candidiasis, including candidemia and disseminated candidiasis, as well as the treatment of cryptococcal meningitis and other site infections in patients with weakened immune functions, including those with AIDS. It is used as maintenance therapy to prevent relapse of cryptococcosis in AIDS patients. Additionally, it is utilized for prevention in patients at risk of fungal infections due to neutropenia following chemotherapy or radiation therapy. Finally, it is effective in the treatment of onychomycosis, athlete's foot, and dermatophyte infections of the skin such as tinea corporis and tinea cruris. Overall, this drug is used for the treatment and prevention of various types of 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. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400 mg once 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 clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once 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 be continued for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily, depending on the patient’s level 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. 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 has increased to 1,000 cells/mm3 or more. 6. For 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 new toenail to grow; growth rate may vary by individual and age. In some cases, the nails may remain damaged after successful treatment with long-term administration. For cutaneous fungal 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, treatment of athlete’s foot may be needed for 6 weeks depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If 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 when it is administered as a single dose. However, when 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 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 non-dialysis days, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be used in certain patients. For example, individuals with allergies to this drug or similar drugs, pregnant or breastfeeding women, and patients taking certain medications should avoid taking this drug. Caution should be exercised when administering this drug to patients with renal or hepatic impairment, as well as to patients with heart disease or those at risk of arrhythmias. Additionally, because interactions may occur when taken with other medications, it is essential to consult a doctor or pharmacist. Rarely, serious side effects may occur while taking this medication, and abnormalities related to liver function or blood have been reported. Symptoms such as abdominal pain, diarrhea, headache, and rash may occur, so contact healthcare professionals immediately if any unusual symptoms arise. During pregnancy, the use of this medication may harm the fetus, so women of childbearing potential should consult a specialist before taking it and should employ effective contraception during treatment. It is also advisable for breastfeeding women to refrain from taking this medication. This drug can interact with various medications, so if other medications are being taken, it is essential to inform healthcare professionals and receive careful management. Special caution should be taken when used in conjunction with drugs that may affect the heart or are metabolized in the liver. Dizziness or seizures may occur while driving or operating machinery, so caution is advised. In the event of an overdose, hallucinations or abnormal behavior may appear, so immediate medical attention is required.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, flatulence, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver 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, agitated 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 entry of air or moisture, and it is best to keep it at room temperature between 1 degree and 30 degrees Celsius. By storing it this way, the effective use and safety of the medication can be maintained.

Appearance and packaging

Appearance

Pink rectangular tablet

Package unit

4 tablets (4 tablets/PTP x 1), 30 tablets/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.