Medication info

Fluzcan Capsule 150 mg (Fluconazole)

Prescription medicationOralExpired
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
Huons Life Science Co., Ltd.
Appearance
Capsule with a blue upper part and a light blue lower part filled with white powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 201803764 · Approved 2018.09.18

This product's status changed to Expired on 2023.09.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of candidiasis and cryptococcosis, treatment of cutaneous fungal infections, 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 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 is determined according to clinical response and medical judgment. 3. 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 clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed initial therapy. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg 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 expected prolonged period of neutropenia, as may occur with bone marrow transplantation. In these patients, administer 400 mg beginning 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. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary between individuals and with age. In some cases, nails may remain damaged even after successful treatment with long-term administration. For fungal skin 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 disease. 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 given. 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 needed for 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 ≤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 days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Huons Life Science Co., Ltd.

Efficacy & effects

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

  • Vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidal infections
  • cryptococcal meningitis
  • cryptococcosis
  • fungal infections
  • neutropenia
  • onychomycosis
  • tinea pedis
  • tinea corporis
  • tinea cruris
View approved original text

This medication is used for the treatment of acute or recurrent vulvovaginal candidiasis. It is also effective for candidemia, systemic candidiasis, and various invasive candidal infections (peritonitis, endocarditis, lung and urinary tract infections, etc.). It is utilized for the treatment of cryptococcal meningitis and cryptococcosis in patients with normal immune function as well as in immunocompromised patients, such as those with AIDS or organ transplant recipients. It is particularly used for maintenance therapy to prevent recurrent cryptococcosis in AIDS patients. Additionally, it is used to prevent fungal infections in patients with weakened immunity due to cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation, and it is effective for treating various skin fungal infections such as onychomycosis, tinea pedis, and tinea corporis. This medication is widely used for the treatment and prevention 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 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 is determined according to clinical response and medical judgment. 3. 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 clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed initial therapy. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg 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 expected prolonged period of neutropenia, as may occur with bone marrow transplantation. In these patients, administer 400 mg beginning 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. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary between individuals and with age. In some cases, nails may remain damaged even after successful treatment with long-term administration. For fungal skin 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 disease. 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 given. 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 needed for 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 ≤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 days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be administered to certain patients. Individuals allergic to this medication or similar drugs, as well as pregnant or breastfeeding women, should not use it. Additionally, patients with specific heart conditions or those at risk of arrhythmias, as well as those taking certain medications, should not use this drug. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. When using this drug, it is crucial to consider the patient's history of drug allergies, renal or liver dysfunction, and heart disease. Special caution is needed for patients with compromised liver function as the drug may worsen liver function. This drug may interact with various medications, so patients taking other medicines must inform their doctor or pharmacist. Close monitoring is necessary when used with drugs affecting the heart or metabolized by the liver. Although this medication is generally well tolerated, rare side effects such as blood abnormalities, liver dysfunction, skin rashes, cardiac arrhythmias, gastrointestinal symptoms, etc., may occur. If these symptoms arise, immediately notify healthcare professionals. Pregnant women or those who may become pregnant should ensure effective contraception during and after taking this medication, especially in early pregnancy. Breastfeeding women are advised to avoid using this medication as it may be excreted in breast milk. The safety of this medication in children, especially infants under 6 months, has not been established, so it should only be used cautiously when absolutely necessary. Caution is advised when driving or operating machinery, as dizziness or seizures may occur due to this medication. In cases of overdose, hallucinations or abnormal behavior may arise; immediate medical attention should be sought for appropriate treatment. This drug is mainly excreted through urine, so in cases of overdose, it may be necessary to increase fluid intake for prompt excretion, and blood dialysis may be required.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocyte 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 reactions with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or humidity. It is advisable to keep it at room temperature between 1 to 30 degrees Celsius to maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

Capsule with a blue upper part and a light blue lower part filled with 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.