Medication info
Diflucan Capsule (Fluconazole)

Diflucan Capsule (Fluconazole)

Prescription medicationHard capsule
Ingredient · strength
Fluconazole›50mg / 1 capsule
Manufacturer / importer
Medix Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a blue upper part and a white lower part containing white powder.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201403574 · Approved 2014.07.31 · Insurance code 625800190

Summary

Main use
Treatment of candidiasis, cryptococcosis, and cutaneous fungal infections; prevention of fungal infections and recurrence
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. Vulvovaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. Oropharyngeal candidiasis: The usual dose of this medicine is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose of this medicine is 50 mg once daily for 14 days, with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose of this medicine is 50 mg once daily for 14-30 days; for refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 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 as a single dose on the first day, followed from the next day by 200 mg once daily; the dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400 mg as a single dose on the first day, followed from the next day by 200-400 mg once daily. 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 therapy. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine 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 infection, such as those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg 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 1,000 cells/mm3 or higher. 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. Dermatophyte 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 response. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, 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. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary 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 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 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 days when dialysis is not performed, administer a reduced dose according to creatinine clearance.
Children's dosage
Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. 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 The safety and efficacy in infants younger than 6 months have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed from the next day by 3 mg/kg once daily. Administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed from the next day by 3 mg/kg once daily. The dose may be increased to 12 mg/kg once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medicine on the first day, followed from the next day by 6 mg/kg once daily. The dose may be increased to 12 mg/kg once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all initial therapy. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, give the oral syrup or intravenous injection, depending on the child's clinical condition, to ensure accurate dosing.

Ingredients

Manufacturer
Medix Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Acute vaginal candidiasis
  • recurrent vaginal candidiasis
  • oropharyngeal infection
  • esophageal infection
  • non-invasive bronchopulmonary infection
  • candiduria
  • cutaneous mucosal candidiasis
  • chronic atrophic oral candidiasis
  • oral pain due to dentures
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
View approved original text

This medication is used to treat acute or recurrent candidiasis. It is effective in treating Candida infections in various areas such as the mouth, pharynx, esophagus, bronchi, skin, and mucous membranes in patients with normal immune function and those with compromised immunity. It is also effective for systemic candidiasis, namely candidemia and disseminated candidiasis, as well as for a variety of invasive Candida infections. It is applied for the treatment of cryptococcal meningitis and cryptococcosis in the lungs, skin, and as maintenance therapy for recurrent cryptococcosis in AIDS patients. This medication is also used to prevent the risk of fungal infections in patients with compromised immunity, as well as for treating onychomycosis, tinea pedis, and other skin fungal infections. It is effective for the treatment and prevention 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. Vulvovaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. Oropharyngeal candidiasis: The usual dose of this medicine is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose of this medicine is 50 mg once daily for 14 days, with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose of this medicine is 50 mg once daily for 14-30 days; for refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 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 as a single dose on the first day, followed from the next day by 200 mg once daily; the dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400 mg as a single dose on the first day, followed from the next day by 200-400 mg once daily. 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 therapy. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine 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 infection, such as those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg 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 1,000 cells/mm3 or higher. 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. Dermatophyte 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 response. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, 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. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary 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 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 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 days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. 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 The safety and efficacy in infants younger than 6 months have not been established. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed from the next day by 3 mg/kg once daily. Administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed from the next day by 3 mg/kg once daily. The dose may be increased to 12 mg/kg once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medicine on the first day, followed from the next day by 6 mg/kg once daily. The dose may be increased to 12 mg/kg once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all initial therapy. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, give the oral syrup or intravenous injection, depending on the child's clinical condition, to ensure accurate dosing.

Precautions

This medication should not be administered to specific patients. For instance, it should not be used in individuals allergic to this drug or similar components, and in pregnant or breastfeeding women. In addition, co-administration with certain medications may cause serious side effects, so combinations should be avoided. Patients who genetically cannot metabolize lactose should also not take this medication. Caution should be exercised when administering this drug to patients with poor kidney or liver function, those with heart disease or at risk of arrhythmias. Patients with a history of drug allergies also require careful monitoring. This drug can inhibit certain enzymes, potentiating the effects of other medications; thus, one should consult with healthcare providers if taking other medications. While taking this drug, side effects such as headache, abdominal pain, diarrhea, vomiting, and skin rash may occur. Rarely, severe liver damage, blood abnormalities, or cardiac arrhythmias may occur, so any unusual symptoms should be reported to medical staff immediately. It is especially important to undergo regular liver or kidney function tests while on this medication, and blood tests may be necessary as well. During pregnancy, contraceptive measures are essential to prevent fetal effects, and it is advisable not to use this medication while breastfeeding. The safety of this medication in children and infants has not been established, so it should only be used cautiously when absolutely necessary. This medication can occasionally cause symptoms such as dizziness or seizures, necessitating caution when driving or operating machinery. If an overdose occurs, hallucinations or abnormal behaviors may appear, and immediate medical treatment is required. This drug is primarily excreted in urine and can also be partially removed through hemodialysis.

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, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic 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 swelling, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, psychomotor agitation

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

Storage

This medication should be stored in a tightly closed container to protect from air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage can effectively maintain the drug's effectiveness.

Appearance and packaging

Appearance

A hard capsule with a blue upper part and a white lower part containing white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.