Medication info
Fluconazole 150 mg Tablets

Fluconazole 150 mg Tablets

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

MFDS item code 201902399 · Approved 2019.04.18 · Insurance code 670501590

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; 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 rapidly and almost completely absorbed; therefore, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single 150 mg oral dose 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 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 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 usually 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 all 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 risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as bone marrow transplant recipients with severe neutropenia or in whom prolonged neutropenia is expected. In these patients, 400 mg should be administered beginning 5-6 days before the anticipated onset of neutropenia and continued 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 uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary by individual and age. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermal 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 condition. 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 medicine is excreted primarily 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 shown below. 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 days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Ingredients

Manufacturer
Boryung Biopharma Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous fungal infections; 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
  • neutropenia
  • onychomycosis
  • athlete's foot
  • tinea corporis
  • tinea cruris
View approved original text

This medication is used to treat and prevent various fungal infections. It is effective against various Candida infections, including acute or recurrent vaginal candidiasis, systemic candidiasis, and candidemia. It is also used to treat and maintain cryptococcal meningitis and cryptococcosis in immunocompromised patients. It helps prevent fungal infections in patients with compromised immune systems due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. Additionally, it is widely used to treat dermatophyte infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and skin candidiasis. This drug is effective in treating and preventing various fungal infections.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single 150 mg oral dose 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 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 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 usually 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 all 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 risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as bone marrow transplant recipients with severe neutropenia or in whom prolonged neutropenia is expected. In these patients, 400 mg should be administered beginning 5-6 days before the anticipated onset of neutropenia and continued 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 uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary by individual and age. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermal 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 condition. 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 medicine is excreted primarily 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 shown below. 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 days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Precautions

This medication should not be used in patients who have had allergic reactions to certain drugs or ingredients. Pregnant women or those who may become pregnant, as well as breastfeeding women, should not take this medication. Caution is required when taken with drugs that may affect the heart. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with impaired renal or liver function, and those with heart disease, should use this medication with greater caution. This medication inhibits enzymes involved in drug metabolism in the liver, so interactions may occur when taken with other drugs; consultation with a doctor or pharmacist is essential. Regular monitoring of liver function, kidney function, and blood tests during this medication is important. Rarely, serious skin reactions or liver damage may occur, so if any unusual symptoms arise, immediate consultation with medical personnel is necessary. Taking this medication during pregnancy may harm the fetus, so contraception is necessary if planning to become pregnant or if already pregnant, and the use of this medication should be avoided. In breastfeeding mothers, as this medication excretes into breast milk, it is advised to discontinue breastfeeding or avoid taking this medication. The safety of this medication in children, especially infants under 6 months, has not been established, so it should only be used with caution when absolutely necessary. Rarely, dizziness or seizures may occur while taking this medication, so caution is needed when driving or operating machinery. In cases of overdose, hallucinations or behavioral abnormalities may occur, requiring immediate medical treatment.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to preserve its effectiveness for a longer time.

Appearance and packaging

Appearance

Pink rectangular tablets

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.