Medication info
Fuzol Capsule 150 mg (Fluconazole)

Fuzol Capsule 150 mg (Fluconazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
Capsules filled with white powder, with a dark blue upper part and a light blue lower part.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 202002190 · Approved 2020.03.30

Summary

Main use
Treatment of candidiasis and dermatomycosis; treatment and prevention of recurrence of cryptococcosis; 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. ○ 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 medication 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 the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medication 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 the clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer this medication at 200 mg once daily indefinitely after the patient has completed all initial treatment. 5. 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 50-400 mg of this medication once daily, depending on 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 undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue administering 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). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; the growth rate may vary among individuals and with age. In some cases, the fingernails or toenails 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 medication is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue 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 medication is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose; however, when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the next day as follows. Creatinine clearance (mL/min) / Recommended dose > 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 non-dialysis days, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

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

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

This medication is used for a variety of Candida infections, including acute or recurrent candidiasis and systemic candidiasis. It is also effective for treating cryptococcal meningitis and external site infections in immunocompromised patients, as well as maintenance therapy to prevent the recurrence of cryptococcosis in AIDS patients. Furthermore, it is important for preventing fungal infections in patients with neutropenia due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. It is also used to treat cutaneous fungal infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. This drug effectively improves these 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 medication 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 the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medication 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 the clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer this medication at 200 mg once daily indefinitely after the patient has completed all initial treatment. 5. 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 50-400 mg of this medication once daily, depending on 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 undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue administering 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). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; the growth rate may vary among individuals and with age. In some cases, the fingernails or toenails 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 medication is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue 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 medication is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose; however, when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the next day as follows. Creatinine clearance (mL/min) / Recommended dose > 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 non-dialysis days, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be used in certain patients. You should not take this medication if you are allergic to fluconazole or similar medications. Women who are pregnant or may become pregnant, as well as nursing mothers, should also not use this medication. Additionally, patients taking certain heart-related medications or some other drugs may risk complications when taking this medication concurrently, so they should avoid it. This medication contains lactose and is unsuitable for patients with lactose intolerance. Patients with renal or liver function issues need to exercise caution when using this drug. Patients with heart disease or those with electrolyte imbalances may experience cardiac problems such as arrhythmia when taking this medication. This drug inhibits enzymes involved in drug metabolism in the liver, resulting in many interactions with other drugs; thus, if you are taking any other medications, be sure to consult a doctor or pharmacist. This medication is usually well tolerated, but rarely, issues such as blood-related problems, allergic reactions, liver function abnormalities, skin rashes, and gastrointestinal disturbances may occur. If liver function is affected, careful consideration is required to continue treatment. During pregnancy, this drug should be avoided due to potential harm to the fetus, and effective contraception should be practiced for at least one month during and after the treatment period. It is also advisable to avoid use during breastfeeding since this drug can be excreted in breast milk. Safety has not been established for infants under 6 months old; use should only occur if absolutely necessary. Caution is advised when taking this medication as dizziness or seizures may occur during driving or operating machinery. In the case of overdose, hallucinations or abnormal behavior may occur, necessitating immediate medical attention, and treatments such as gastric lavage or dialysis may be required.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, increase in serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocyte 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 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

This medication should be stored in a tightly sealed container to protect it from air and moisture. Furthermore, it is important to avoid storing the medication in extremely hot or cold places, maintaining a temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Capsules filled with white powder, with a dark blue upper part and a light blue lower part.

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.