Medication info
Fluconazole 150 mg Tablet

Fluconazole 150 mg Tablet

Prescription medicationTabletOral
Ingredient · strength
Fluconazole›150mg / 1 tablet
Manufacturer / importer
Myungmoon Pharmaceutical Co., Ltd.
Appearance
Pink oblong tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200701824 · Notified 2007.02.09 · Insurance code 649803490

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. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (tablets, capsules, dry syrup) and injections 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 drug is 400mg once on the first day, followed by 200mg once daily from the next day. The dose may be increased to 400mg once daily according to the patient's response. The duration of treatment should be determined based on clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400mg once on the first day, followed by 200 ~ 400mg 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 200mg of this drug 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~ 400mg of this drug once daily, depending on the patient's degree of risk of fungal infection. A dose of 400mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. In these patients, administer 400mg beginning 5-6 days before the expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000cells/ 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 6-12 months; growth rate may vary between individuals and with 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 drug 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 its course. For tinea versicolor, administer 50mg 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 drug is excreted mainly in the urine unchanged. Dose adjustment is not necessary for a single dose. If 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 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
Myungmoon Pharmaceutical 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
  • fungal infections
  • onychomycosis
  • athlete's foot
  • tinea corporis
  • tinea cruris
View approved original text

This medication is used to treat acute or recurrent vaginal candidiasis, systemic candidiasis (including bloodstream infections and invasive infections in various organs), cryptococcal meningitis and other site infections in immunocompromised patients. It is also effective in preventing recurrence of cryptococcosis in AIDS patients and fungal infections in patients with immunosuppression caused by cytotoxic chemotherapy. It also helps treat various skin fungal infections such as onychomycosis, athlete's foot, and tinea corporis. It is used to improve a variety of fungal infections.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (tablets, capsules, dry syrup) and injections 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 drug is 400mg once on the first day, followed by 200mg once daily from the next day. The dose may be increased to 400mg once daily according to the patient's response. The duration of treatment should be determined based on clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400mg once on the first day, followed by 200 ~ 400mg 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 200mg of this drug 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~ 400mg of this drug once daily, depending on the patient's degree of risk of fungal infection. A dose of 400mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. In these patients, administer 400mg beginning 5-6 days before the expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000cells/ 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 6-12 months; growth rate may vary between individuals and with 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 drug 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 its course. For tinea versicolor, administer 50mg 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 drug is excreted mainly in the urine unchanged. Dose adjustment is not necessary for a single dose. If 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 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 medicine should not be given to certain patients. For example, those allergic to this medication or similar components, pregnant or potentially pregnant women, and nursing mothers should not take this medicine. Moreover, patients taking certain medications should not use this medicine concurrently. It can be dangerous when combined with drugs that may affect the heart, certain antibiotics, antihistamines, etc., so caution is necessary. This medicine contains lactose and should not be taken by individuals with lactose intolerance or related genetic disorders. Patients with kidney or liver problems should use this medicine with greater caution. Liver function may deteriorate, so the liver condition should be monitored continuously, and individuals with heart disease or electrolyte imbalances should be cautious as heart issues like arrhythmias may occur. This medicine can interact with various drugs; thus, those taking other medications must consult with their doctor or pharmacist. In particular, combining with drugs metabolized in the liver can increase blood concentration, raising the risk of side effects. During treatment, it is important to regularly carry out blood tests, liver function tests, and kidney function tests to check for abnormalities. This medication generally has good tolerability, but in rare cases, it may cause blood disorders, liver dysfunction, skin rashes, heart arrhythmias, gastrointestinal disturbances, etc. If any unusual symptoms occur, it is essential to inform medical personnel immediately. It is advisable not to use this medicine during pregnancy, and women of childbearing potential must employ effective contraception during and for a period after treatment. Nursing mothers are also advised against using this medication. For infants younger than 6 months, safety has not been established, so it should only be used cautiously when absolutely necessary. Caution should be exercised when driving or operating machinery as dizziness or seizures may occur. In case of an overdose, symptoms like hallucinations or unusual behavior may present, and immediate hospital treatment should be sought. This medication is primarily excreted in urine, so increasing urine output may help, and some can be removed via hemodialysis.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, 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, 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, delirium

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This will help preserve the effectiveness of the medicine.

Appearance and packaging

Appearance

Pink oblong tablet

Package unit

30 tablets/bottle, 100 tablets/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.