Medication info
Disflu Capsule 150 mg (Fluconazole)

Disflu Capsule 150 mg (Fluconazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
Dasan Pharmaceutical Co., Ltd.
Appearance
Capsule filled with white powder, with a dark blue upper part and a light blue lower part.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 200708744 · Notified 2007.07.27 · Insurance code 678600300

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment of cryptococcosis and prevention of recurrence; 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 preparations are rapidly and almost completely absorbed, the doses of oral preparations (tablets, capsules, dry syrup) and injectable preparations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole 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 product 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 the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this product 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 the 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 product once daily indefinitely after the patient has completed all initial therapy. 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 product 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 infections, such as those undergoing bone marrow transplantation who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, and continue administering 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 take about 6-12 months; the growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this product is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment for athlete's foot may need to continue for 6 weeks, depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients 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 product 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 of treatment and adjust the dose from the next 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 hemodialysis: 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Dasan Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous fungal infections; treatment of cryptococcosis and prevention of recurrence; prevention of fungal infections

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

This medication is used to treat acute or recurrent candidiasis, systemic candidiasis (infections in multiple locations such as blood, peritoneum, lungs, etc.), and cryptococcal infections that occur in patients with impaired immune function. It is also used for maintenance therapy to prevent recurrence of cryptococcosis in AIDS patients and helps prevent fungal infections in immunocompromised patients due to chemotherapy or bone marrow transplantation. It is effective for fungal infections of the skin and fingernails/toenails. In summary, this medication is widely used for 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 preparations are rapidly and almost completely absorbed, the doses of oral preparations (tablets, capsules, dry syrup) and injectable preparations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole 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 product 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 the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this product 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 the 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 product once daily indefinitely after the patient has completed all initial therapy. 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 product 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 infections, such as those undergoing bone marrow transplantation who have severe neutropenia or are expected to have prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, and continue administering 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 take about 6-12 months; the growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this product is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment for athlete's foot may need to continue for 6 weeks, depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients 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 product 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 of treatment and adjust the dose from the next 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 hemodialysis: 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be administered to certain patients. Firstly, individuals with a history of allergy to this medication or similar substances should not use it. Secondly, it is recommended that pregnant women or women who may become pregnant, as well as breastfeeding women, avoid taking this medication. Thirdly, serious side effects may occur when taken with certain drugs, so it is essential to consult a doctor or pharmacist if currently taking any medications. Additionally, individuals with genetic metabolic disorders such as lactose intolerance should avoid this medication. This medication must be used with caution in patients with kidney or liver dysfunction. Special care is required if there are heart conditions or electrolyte imbalances, as there is a risk of cardiac rhythm abnormalities. Furthermore, it can worsen liver function, so regular monitoring of liver health is necessary. Rarely, side effects such as blood or immune system abnormalities, liver function irregularities, and skin rashes may occur while taking this medication. Sometimes severe liver damage or cardiac arrhythmias may also occur, so symptoms should be promptly reported to a healthcare provider. It is recommended to conduct blood tests, liver function tests, and kidney function tests before administration. If clinically significant elevations in liver enzyme levels occur, the decision to continue administering this medication must be made cautiously. This medication has a significant number of interactions with other drugs, necessitating dosage adjustments or monitoring based on co-administered drugs. Caution should be exercised, especially when combined with drugs affecting the heart, anticoagulants, antiepileptics, immunosuppressants, etc. It should be avoided during pregnancy, and effective contraception is recommended during the treatment period and for one month after therapy. Breastfeeding women are also advised against taking this medication. Safety has not been established in pediatric patients, especially infants under 6 months old, and it should only be used cautiously when strictly necessary. Care should be taken when driving or operating machinery as this medication may cause dizziness or seizures. In case of overdose, hallucinations or abnormal behaviors may occur, and immediate medical treatment must be sought. Gastric lavage or supportive therapy may be necessary in case of overdose, and hemodialysis may assist in drug removal.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade 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, 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 reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

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

Storage

This medicine should be stored in an airtight container to protect it from air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

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

Package unit

30 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.