Medication info
Il Sung Fluconazole Capsule 150 mg

Il Sung Fluconazole Capsule 150 mg

Prescription medicationHard capsuleOral
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
Il Sung IS Co., Ltd.
Appearance
Capsule filled with white powder, upper dark blue and lower light blue
Packaging
30 capsules/bottle
Approval status
Active

MFDS item code 201908478 · Approved 2019.12.17 · Insurance code 655404480

Summary

Main use
Treatment of candidiasis and cutaneous mycoses, 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 absorbed rapidly and almost completely; therefore, 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 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 is determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine 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 be continued for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200mg of this medicine once daily indefinitely after the patient has completed primary 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 50~ 400mg of this medicine once daily, depending on the patient's 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 undergoing bone marrow transplantation, in whom severe or prolonged neutropenia is expected. In these patients, administer 400mg starting 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 usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary among individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For fungal skin infections, including athlete's foot (tinea pedis), tinea corporis, 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 50mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose is generally 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 dosage adjustment is necessary for a single dose, but if multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as follows. 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 regular dialysis: 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, reduce the dose according to creatinine clearance.

Ingredients

Manufacturer
Il Sung IS Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous mycoses, treatment and prevention of recurrence of cryptococcosis, prevention of fungal infections

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

This medication is effective for the treatment of acute or recurrent vaginal candidiasis, as well as invasive candidal infections such as candidemia and systemic candidiasis. It is also used for the treatment of cryptococcal meningitis and other cryptococcosis in patients with impaired immunity, such as those with AIDS or organ transplant recipients. It is suitable for maintenance therapy to prevent recurrence of cryptococcosis in patients with AIDS. It also helps to prevent fungal infections in patients undergoing cytotoxic chemotherapy, radiotherapy, or those with neutropenia after bone marrow transplantation. This medication is also used for various skin fungal infections including onychomycosis, tinea pedis, tinea corporis, tinea cruris, and tinea versicolor. Therefore, it is effective in improving the treatment of both systemic and localized fungal infections.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, 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 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 is determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine 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 be continued for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200mg of this medicine once daily indefinitely after the patient has completed primary 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 50~ 400mg of this medicine once daily, depending on the patient's 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 undergoing bone marrow transplantation, in whom severe or prolonged neutropenia is expected. In these patients, administer 400mg starting 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 usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary among individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For fungal skin infections, including athlete's foot (tinea pedis), tinea corporis, 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 50mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose is generally 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 dosage adjustment is necessary for a single dose, but if multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as follows. 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 regular dialysis: 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, reduce the dose according to creatinine clearance.

Precautions

This medication should not be administered to certain patients. For example, patients who have had allergic reactions to this medication or similar drugs, pregnant women or those who may become pregnant, nursing mothers, and patients taking certain medications should not use this drug. This drug contains lactose, so it should not be given to patients with lactose intolerance or related genetic conditions. Use this drug with caution in patients with impaired renal or liver function, those with heart disease or at risk of arrhythmia, and patients with a history of drug allergies. The condition of these patients should be closely monitored during treatment. This drug may interact with various medications, so if you are taking other medications, you must consult with your healthcare provider. Special caution is required when taken with medications that affect the heart, drugs metabolized by the liver, anticoagulants, immunosuppressants, and antidepressants. While this medication is generally well tolerated, it can rarely cause adverse effects such as abnormalities in blood, liver, or kidney function, serious skin reactions, or cardiac arrhythmias. If any unusual symptoms occur, notify your healthcare provider immediately. Its use during pregnancy could pose a risk to the fetus, so it should be avoided whenever possible, and fertile women should use effective contraception during and after treatment for a certain period. Nursing mothers are also advised against using this medication. The safety of this drug in children, particularly infants under 6 months old, has not been fully established, so it should only be used cautiously when necessary. Caution is needed when driving or operating machinery after taking this medication as dizziness or seizures may occur. In cases of overdose, hallucinations or abnormal behavior may occur, and appropriate treatment should be sought immediately. This drug is primarily excreted in the urine, so measures to increase urine output may be helpful in the event of overdose.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic 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, 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 medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius to preserve its effectiveness for a longer period.

Appearance and packaging

Appearance

Capsule filled with white powder, upper dark blue and lower light blue

Package unit

30 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.