Medication info

Fluconazole 150 mg Tablet (Fluconazole)

Prescription medicationExpired
Ingredient · strength
Fluconazole›Strength being verified
Manufacturer / importer
Ilhwa Co., Ltd.
Appearance
Pink oval tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 200701196 · Notified 2007.01.17

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment and prevention of recurrence of cryptococcosis; prevention of fungal infections
Who uses it
Adults
Adult dosage
The route of administration is determined according to the patient's clinical condition. As absorption of oral formulations is rapid and nearly complete, 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 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 is determined according to the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine 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 usually be continued 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 all primary 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 medicine once daily, depending on 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 infections, such as those with severe neutropenia or expected to have prolonged neutropenia, as in the case of bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before the expected onset of neutropenia and continued at 400 mg for 1 week after the neutrophil count has increased to ≥1,000 cells/mm3. 6. For onychomycosis, administer 150 mg once a week 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 by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. 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 a week 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 when administering 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 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 receiving hemodialysis should be given 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
Ilhwa Co., Ltd.

Efficacy & effects

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

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

This medicine is effective for treating acute or recurrent vulvovaginal candidiasis as well as candidemia and systemic candidiasis. It is also used to treat cryptococcal meningitis and other forms of cryptococcosis in patients with impaired immune function. This medication is used for maintenance therapy to prevent recurrence of cryptococcosis in AIDS patients and aids in the prevention of fungal infections in patients with neutropenia due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. Additionally, it is suitable for treating skin fungal infections such as onychomycosis, athlete's foot, and tinea corporis. This drug is widely used for the treatment and prevention of various fungal infections.

Dosage and Administration

Adult dosage

The route of administration is determined according to the patient's clinical condition. As absorption of oral formulations is rapid and nearly complete, 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 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 is determined according to the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine 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 usually be continued 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 all primary 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 medicine once daily, depending on 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 infections, such as those with severe neutropenia or expected to have prolonged neutropenia, as in the case of bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before the expected onset of neutropenia and continued at 400 mg for 1 week after the neutrophil count has increased to ≥1,000 cells/mm3. 6. For onychomycosis, administer 150 mg once a week 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 by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. 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 a week 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 when administering 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 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 receiving hemodialysis should be given 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. Patients who are allergic to this drug or azole antifungals, who are pregnant or may become pregnant, and those who are breastfeeding should not use this medication. Furthermore, serious side effects may occur when taken with certain medications; therefore, concurrent use should be avoided. Patients with hereditary lactose intolerance or related metabolic disorders should also not take this medication. This medication should be administered cautiously in patients with compromised renal or liver function, those with heart diseases, or electrolyte imbalances that increase the risk of arrhythmias. Additionally, patients with a history of drug hypersensitivity or those currently taking specific medications require caution. This medication can affect liver and kidney function, so regular testing during treatment is necessary. Generally well tolerated, this medication may rarely cause adverse reactions in blood, liver, kidneys, skin, or nervous system. Particularly, declines in liver function or serious skin reactions may occur, necessitating immediate consultation with healthcare providers if symptoms arise. During treatment with this medication, regular blood tests and assessments of liver and kidney function should be conducted, along with monitoring for adrenal function abnormalities or cardiac arrhythmia risks. This medication has numerous drug interactions, necessitating caution when combined with other drugs. Specifically, when used with drugs that affect the heart or those metabolized by the liver, dose adjustments and patient monitoring are required. Avoid using this medication during pregnancy, and women of childbearing age should employ effective contraception during treatment and for a certain period afterward. It is also safe for breastfeeding women to refrain from taking this medication. Safety for infants under 6 months has not been established, so it should be administered cautiously only when absolutely necessary. Caution is warranted when driving or operating machinery after taking this medication, as dizziness or seizures may occur. In case of overdose, hallucinations or disturbed behavior may appear, requiring immediate medical attention. This medication is primarily excreted in urine, and some can be removed through hemodialysis, making it important to follow healthcare provider directions in case of overdose.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, pruritus, 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, malaise, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help preserve the drug's effectiveness.

Appearance and packaging

Appearance

Pink oval tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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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.