Medication info
Piluko Tablet 150 mg (Fluconazole)

Piluko Tablet 150 mg (Fluconazole)

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

MFDS item code 201805360 · Approved 2018.12.28

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment and suppression 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 rapidly and almost completely absorbed, 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 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 this medicine 200 mg once daily indefinitely after the patient has completed all initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer this medicine 50-400 mg 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 those with severe or expected prolonged neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg 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 new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails 6-12 months; growth rates may vary by individual and age. In some cases, the nails may remain damaged even after successful treatment with long-term administration. Dermatophyte skin 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 infection. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. In the presence of 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 needed 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
HyunDae Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous fungal infections; treatment and suppression 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
  • nail fungus
  • athlete’s foot
  • tinea corporis
View approved original text

This medication is primarily used to treat systemic candidiasis infections that spread acutely or recurrently, such as acute or recurrent vulvovaginal candidiasis and candidemia. Additionally, it helps treat cryptococcal meningitis and cryptococcosis occurring in various sites such as lungs and skin, especially as maintenance therapy to prevent recurrence of cryptococcosis in AIDS patients. It is effective in preventing fungal infections in immunocompromised patients, for instance those experiencing neutropenia due to cytotoxic chemotherapy or radiation therapy. Furthermore, it is used for the treatment of dermatophytosis, athlete’s foot, and tinea corporis. This drug effectively aids in the treatment and prevention of various 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 rapidly and almost completely absorbed, 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 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 this medicine 200 mg once daily indefinitely after the patient has completed all initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer this medicine 50-400 mg 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 those with severe or expected prolonged neutropenia, as in bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg 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 new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails 6-12 months; growth rates may vary by individual and age. In some cases, the nails may remain damaged even after successful treatment with long-term administration. Dermatophyte skin 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 infection. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. In the presence of 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 needed 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be used in patients with specific allergic reactions or hypersensitivity to azole drugs. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication. Additionally, this drug and certain medications may affect heart function, so concomitant use is prohibited or requires caution. Patients with metabolic issues such as lactose intolerance should also avoid this drug. Patients with kidney or liver function problems should be cautious when using this medication, as there is a risk of liver function deterioration. Patients with heart disease or electrolyte abnormalities should be administered this medication carefully due to the risk of arrhythmias. This drug inhibits various drug metabolism enzymes, leading to many drug interactions, necessitating careful observation when used in conjunction with other medications. Generally, this medication has good tolerability, but side effects such as blood, liver, and kidney function abnormalities or skin rashes may occur infrequently. In particular, patients with severe underlying conditions are at risk of liver damage, so regular liver function tests are required. Blood tests, liver function tests, and kidney function tests are recommended during the use of this drug. QT interval prolongation should be checked via ECG, and patients with hypokalemia or heart failure are at increased risk of arrhythmias. This drug may be less effective against certain resistant Candida species, and alternative treatment may be necessary in case of treatment failure. Caution should be exercised while driving or operating machinery, as dizziness or seizures may occur. In cases of overdose, hallucinations or behavioral changes may occur, requiring immediate medical attention and, if necessary, gastric lavage and supportive treatment. This drug is excreted through the kidneys, so some can be removed through hemodialysis.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, peripheral neuropathy, taste disturbance, tremors, 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, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions 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

Store this medication in a tightly closed container as it may be sensitive to air or moisture. It is recommended to maintain room temperature between 1 to 30 degrees Celsius to prolong the medication's effectiveness.

Appearance and packaging

Appearance

Pink rectangular tablet

Package unit

30 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.