Medication info
Hyutex Fluconazole Tablets 150 mg

Hyutex Fluconazole Tablets 150 mg

Prescription medicationTabletOral
Ingredient · strength
Fluconazole›150mg / 1 tablet
Manufacturer / importer
Hyutex Pharmaceutical Co., Ltd.
Appearance
Pink oblong tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201902018 · Approved 2019.04.03 · Insurance code 649104360

Summary

Main use
Treatment of candidiasis and dermatomycosis, treatment and prevention of recurrence of cryptococcosis, and 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 a single oral dose of 150 mg of fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this medicine 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 depending on 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 medicine 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 the 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 of this medicine once daily indefinitely after the patient has completed initial 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 medicine once daily, depending on the patient's degree of 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 those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg beginning 5-6 days before neutropenia is expected to occur, 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 fingernail or toenail has regrown (until an uninfected new nail has grown). A new fingernail usually takes 3-6 months to grow, and a toenail takes about 6-12 months; growth rates may vary among individuals and with age. In some cases, nails may remain damaged even 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 medicine 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 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 medicine 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 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, the dose should be reduced according to creatinine clearance.

Ingredients

Manufacturer
Hyutex Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Acute vulvovaginal candidiasis
  • recurrent vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • systemic candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • fungal infections
  • onychomycosis (nail fungal infection)
  • tinea pedis
  • tinea corporis
View approved original text

This medication is used for the treatment of systemic candidiasis, including acute or recurrent vulvovaginal candidiasis, candidemia, and invasive candidiasis. It is also effective for the treatment of cryptococcal meningitis and cryptococcosis in other parts of the body in immunocompromised patients, as well as for maintenance therapy to prevent recurrence of cryptococcal infection in AIDS patients. Additionally, it assists in the prevention of fungal infections in patients with neutropenia due to cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation. It is also used to treat various skin fungal infections, including dermatophyte infections of the skin and nails, tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor, and cutaneous candidiasis. This drug effectively treats and prevents various types of fungal infections, thereby improving the health of patients.

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 a single oral dose of 150 mg of fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this medicine 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 depending on 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 medicine 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 the 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 of this medicine once daily indefinitely after the patient has completed initial 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 medicine once daily, depending on the patient's degree of 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 those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg beginning 5-6 days before neutropenia is expected to occur, 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 fingernail or toenail has regrown (until an uninfected new nail has grown). A new fingernail usually takes 3-6 months to grow, and a toenail takes about 6-12 months; growth rates may vary among individuals and with age. In some cases, nails may remain damaged even 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 medicine 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 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 medicine 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 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, the dose should be reduced according to creatinine clearance.

Precautions

This drug should not be used in certain patients. For example, individuals who are allergic to this drug or similar drugs, or women who are pregnant or breastfeeding should not take this medication. Additionally, caution is advised as some specific medications may interact with this drug. Patients with a history of allergies or with impaired renal or liver function should exercise particular caution when using this drug. If there are pre-existing heart conditions or electrolyte imbalances, there may be a risk of arrhythmias or other heart problems when taking this medication, so it should be used carefully. While this drug generally has few side effects, rare adverse reactions may occur affecting the blood, liver, skin, and nervous system. Reports have included abdominal pain, headache, rash, and elevated liver enzymes, and severe skin reactions or liver damage may develop. It is important to immediately inform healthcare professionals if any abnormal symptoms occur. This drug can interact with several other medications, so patients should inform their healthcare professionals of all medications they are currently taking. Special attention is needed when taking this drug with heart-related medications, anticoagulants, antiepileptics, immunosuppressants, certain antibiotics, and analgesics as dosage adjustments may be necessary. Women who are pregnant or may become pregnant should use effective contraception during and for a certain period after taking this drug, and it is preferable to avoid use in early pregnancy. Breastfeeding women should also avoid this drug as it may pass into breast milk. The safety of this drug in infants younger than 6 months has not been established, so it should only be used in special cases under strict medical supervision. During the use of this drug, dizziness or seizures may occur while driving or operating machinery, so caution should be exercised. In case of overdose, hallucinations or abnormal behavior may occur, so immediate medical attention should be sought for proper treatment, including support therapy and gastric lavage if necessary. This drug is primarily excreted in urine, so adequate hydration may be helpful.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte 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 reaction with eosinophilia and systemic symptoms (DRESS), 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 closed container to protect it from air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug’s efficacy and safety.

Appearance and packaging

Appearance

Pink oblong tablet

Package unit

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.