Medication info
Diflucan Capsule (Fluconazole)

Diflucan Capsule (Fluconazole)

Prescription medication
Ingredient · strength
Fluconazole›50mg / 1 capsule
Manufacturer / importer
Dongwha Pharmaceutical Co., Ltd.
Appearance
A capsule filled with white powder, blue upper part, and white lower part.
Packaging
30 capsules/bottle
Approval status
Active

MFDS item code 200400757 · Notified 2004.02.23 · Insurance code 642701100

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment of cryptococcosis and prevention of recurrence; prevention of fungal infections
Who uses it
Adults · Children
Adult dosage
The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral discomfort due to dentures): The usual dose is 50 mg of this drug once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this drug once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this drug once on the first day, followed by 200 mg once daily starting 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug once on the first day, followed by 200-400 mg once daily starting 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. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. 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 drug once daily, depending on the patient's degree 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 those with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. 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. 7. 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 age and from person to person. 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 is 50 mg of this drug 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 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should be 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 primarily in the urine unchanged. No dose adjustment is necessary when administered as a single dose; however, when 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 Creatinine clearance (mL/min) 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 nondialysis days, administer a reduced dose according to creatinine clearance.
Children's dosage
○ Pediatric patients Adult dose 100 mg: Pediatric dose 3 mg/kg Adult dose 200 mg: Pediatric dose 6 mg/kg Adult dose 400 mg: Pediatric dose 12 mg/kg Do not exceed 400 mg. Infants younger than 6 months: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily starting the next day. Treatment should be continued for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily starting the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily starting the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed all initial treatment. 6. Pediatric patients with renal impairment: Extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses less than 10 mg, administer the syrup orally or inject the injection intravenously according to the child's clinical condition to ensure accurate dosing.

Ingredients

Manufacturer
Dongwha Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Vulvovaginal candidiasis
  • oropharyngeal infection
  • esophageal infection
  • non-invasive bronchopulmonary infection
  • candiduria
  • mucosal candidiasis
  • chronic atrophic oral candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • cryptococcal meningitis
  • cryptococcosis
View approved original text

This medication is used to treat various candidiasis and cryptococcosis. It treats acute or recurrent vulvovaginal candidiasis and Candida infections occurring in multiple sites such as skin, mucosa, oral cavity, esophagus, bronchi, and lungs. It is also effective against systemic invasive candidiasis such as candidemia. It is used in the treatment of cryptococcal meningitis and other site infections in immunocompromised patients, particularly as a maintenance therapy for preventing recurrence in AIDS patients. It is prescribed for the prevention of fungal infections in patients with neutropenia. It is effective in the treatment of fungal infections such as onychomycosis, tinea pedis, tinea corporis, tinea cruris, and tinea versicolor. Thus, this medication is utilized for the improvement of various fungal infections.

Dosage and Administration

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral discomfort due to dentures): The usual dose is 50 mg of this drug once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this drug once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this drug once on the first day, followed by 200 mg once daily starting 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug once on the first day, followed by 200-400 mg once daily starting 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. 5. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. 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 drug once daily, depending on the patient's degree 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 those with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. 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. 7. 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 age and from person to person. 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 is 50 mg of this drug 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 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should be 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 primarily in the urine unchanged. No dose adjustment is necessary when administered as a single dose; however, when 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 Creatinine clearance (mL/min) 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Children's dosage

○ Pediatric patients Adult dose 100 mg: Pediatric dose 3 mg/kg Adult dose 200 mg: Pediatric dose 6 mg/kg Adult dose 400 mg: Pediatric dose 12 mg/kg Do not exceed 400 mg. Infants younger than 6 months: Safety and efficacy have not been established. 1. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily starting the next day. Treatment should be continued for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily starting the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis: 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily starting the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed all initial treatment. 6. Pediatric patients with renal impairment: Extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses less than 10 mg, administer the syrup orally or inject the injection intravenously according to the child's clinical condition to ensure accurate dosing.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this drug or other similar components, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Additionally, patients who are taking certain medications should be cautious about using this drug concurrently. For example, it may be dangerous to combine this drug with medications that can affect heart rhythm or those that can interact with this drug. This medication contains lactose, so patients with lactose intolerance or related genetic diseases should avoid taking it. Patients with kidney or liver problems should be more cautious when using this medication, and dosage adjustment or regular testing may be necessary. Patients with heart disease or electrolyte abnormalities may need to be careful with the drug due to the possibility of arrhythmias and other heart issues. This medication should be taken while regularly monitoring various health conditions such as liver and kidney function and blood status, as there have been reports of adrenal insufficiency that need monitoring. Rarely, serious skin reactions or hepatic toxicity may occur, so if symptoms such as skin rash or jaundice appear, immediate consultation with a healthcare professional is necessary. This medication can interact with various drugs, so individuals taking other medications must inform their healthcare providers, and dosage adjustments or careful observation may be needed when combined. Pregnant or nursing women should avoid using this medication, and women of childbearing age should use effective contraception during and for a certain time after taking this medication. The safety of this medication in children, especially infants under 6 months of age, has not been established and should only be used if absolutely necessary. Caution should be exercised as this medication may cause dizziness or seizures when driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors may occur, and immediate medical treatment should be sought. This medication is mainly excreted through urine, and drug concentration can be reduced through hemodialysis.

Side effects

hypogranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, flatulence, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte 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, malaise, asthenia, fever, hallucinations, psychotic behavior

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also important to maintain a temperature between 1 degree and 30 degrees Celsius when storing the drug. This ensures the effectiveness of the medication.

Appearance and packaging

Appearance

A capsule filled with white powder, blue upper part, and white lower part.

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.