Medication info

Prunakan Capsule 150 mg (Fluconazole)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
Jeongwoo Pharmaceutical Co., Ltd.
Appearance
Hard capsule with a dark blue upper part and a light blue lower part containing white to off-white powder
Packaging
30 capsules/bottle, 90 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 201902571 · Approved 2019.04.24

This product's status changed to Expired on 2024.04.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of recurrence or infection of candidiasis (including vaginal candidiasis), cryptococcosis, and cutaneous 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. Vulvovaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Usually administer 400 mg of this medicine once on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: Usually administer 400 mg of this medicine 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 generally continue for at least 6 ~ 8 weeks. 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. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient's level of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 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 approximately 6-12 months; growth rate may vary by individual and age. In some cases, fingernails or toenails may remain damaged even 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: Usually administer 50 mg of this medicine 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 tinea versicolor, administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: This medicine is excreted mainly unchanged in the urine. No dose adjustment is needed for a single dose. For multiple doses, administer the usual dose only on the first day, then adjust the dose as follows from the next day: 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 For patients receiving hemodialysis, administer 100% of the usual dose after each hemodialysis session. On nondialysis days, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Jeongwoo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence or infection of candidiasis (including vaginal candidiasis), cryptococcosis, and cutaneous fungal infections

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

This medication is used to treat invasive fungal infections such as candidemia and systemic candidiasis, including acute or recurrent vulvovaginal candidiasis. It is also effective in the treatment of cryptococcal meningitis and other localized infections in immunocompromised patients, such as those with AIDS and organ transplant recipients. Additionally, it is utilized as maintenance therapy to prevent the recurrence of cryptococcosis in AIDS patients. It is also used to prevent fungal infections in patients experiencing neutropenia due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. It is used to treat dermatophyte infections, including onychomycosis, tinea pedis, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. In summary, it is used for various prevention and treatment 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 rapidly and almost completely absorbed, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Usually administer 400 mg of this medicine once on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: Usually administer 400 mg of this medicine 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 generally continue for at least 6 ~ 8 weeks. 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. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient's level of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 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 approximately 6-12 months; growth rate may vary by individual and age. In some cases, fingernails or toenails may remain damaged even 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: Usually administer 50 mg of this medicine 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 tinea versicolor, administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: This medicine is excreted mainly unchanged in the urine. No dose adjustment is needed for a single dose. For multiple doses, administer the usual dose only on the first day, then adjust the dose as follows from the next day: 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 For patients receiving hemodialysis, administer 100% of the usual dose after each hemodialysis session. On nondialysis days, administer a reduced dose according to creatinine clearance.

Precautions

This medication is a specific azole antifungal used for the treatment of fungal infections. This medication should not be used in patients allergic to this drug or similar compounds, in pregnant women or women who may become pregnant, and in breastfeeding women. Additionally, concomitant use of this medication with certain drugs can cause serious side effects such as cardiac rhythm disturbances, thus co-administration should be avoided. Patients with lactose intolerance or specific genetic metabolic disorders should also avoid this medication. Patients with renal or hepatic dysfunction need to be cautious when using this medication, as it may worsen liver function or increase the risk of cardiac arrhythmia. This drug can inhibit enzymes involved in drug metabolism in the liver, potentially increasing serum concentrations of co-administered medications, necessitating adjustments in types and dosages of concomitant medications. Generally, this drug has good tolerability, but rare cases of blood disorders, liver function abnormalities, allergic reactions, rashes, digestive disturbances, neurological symptoms, etc. may occur. In particular, patients with severe illnesses should have regular blood tests and liver and kidney function tests to detect any abnormal signs early. Use during pregnancy is to be avoided as it may pose risks to the fetus, and it is recommended to use contraception for at least one month after the last dose. Breastfeeding mothers should also avoid using this drug as it is excreted in breast milk. Safety has not been established in infants, so it should only be used cautiously when necessary. This drug may cause dizziness or seizures when driving or operating machinery, thus caution is necessary. In case of overdose, hallucinations or unusual behavior may occur; immediate consultation with healthcare professionals is required, and supportive treatment, gastric lavage, or hemodialysis may be necessary.

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, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatic injury, rash, itching, urticaria, increased sweating, drug eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Hard capsule with a dark blue upper part and a light blue lower part containing white to off-white powder

Package unit

30 capsules/bottle, 90 capsules/bottle, 100 capsules/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.