Medication info
Diphrukan Capsule 50 mg (Fluconazole)

Diphrukan Capsule 50 mg (Fluconazole)

Prescription medicationHard capsule
Ingredient · strength
Fluconazole›50mg / 1 capsule
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
A hard capsule with blue upper and white lower parts containing a white or pale yellow powder.
Packaging
28 capsules (14 capsules/blister X 2), 100 capsules/bottle
Approval status
Active

MFDS item code 200511060 · Notified 2005.07.18 · Insurance code 648900200

Summary

Main use
Treatment of candidiasis and dermatomycosis; 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. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose 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 is 50 mg once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose 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 (peritoneum, endocardium, lungs, urinary tract, etc.): The usual dose is 400 mg once on the first day, followed from the next day by 200 mg once daily; 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 the clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg once on the first day, followed from the next day by 200 – 400 mg once daily. The duration of treatment is determined by the 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, after completion of initial therapy, administer at least 200 mg once daily indefinitely. 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 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 with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. In such patients, administer 400 mg beginning 5-6 days before the anticipated 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 of the fingernails and toenails, administer 150 mg once weekly until the nails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails 6-12 months; growth rates may vary by individual and age. In some cases, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose 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 infection. 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 drug is excreted mainly unchanged in the urine. No dose adjustment is necessary when administering a single dose. When multiple doses are required, administer the usual dose only on the first day, 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 Hemodialysis patients: 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 doses based on adult doses are generally determined according to the following guidelines 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 Safety and efficacy have not been established in infants under 6 months of age. Oropharyngeal candidiasis: Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue 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 (peritoneum, endocardium, lungs, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg on the first day, followed from the next day by 6 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue 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 completion of initial therapy. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

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

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

This medication is effective for various diseases associated with candidiasis. It is used to treat acute or recurrent vaginal candidiasis and treats Candida infections in various areas such as the oral cavity, esophagus, bronchi, lungs, and skin mucosa. It is also effective for invasive fungal infections, such as candidemia and systemic candidiasis. It is used to treat and prevent cryptococcal meningitis and other forms of cryptococcosis in patients with weakened immune systems and helps prevent fungal infections due to neutropenia. It is also used to treat dermatophyte infections such as onychomycosis and tinea. In summary, this medication is used for the treatment and prevention of a wide range of fungal infections.

Dosage and Administration

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose 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 is 50 mg once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose 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 (peritoneum, endocardium, lungs, urinary tract, etc.): The usual dose is 400 mg once on the first day, followed from the next day by 200 mg once daily; 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 the clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg once on the first day, followed from the next day by 200 – 400 mg once daily. The duration of treatment is determined by the 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, after completion of initial therapy, administer at least 200 mg once daily indefinitely. 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 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 with severe neutropenia or an anticipated prolonged period of neutropenia, as in bone marrow transplantation. In such patients, administer 400 mg beginning 5-6 days before the anticipated 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 of the fingernails and toenails, administer 150 mg once weekly until the nails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails 6-12 months; growth rates may vary by individual and age. In some cases, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose 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 infection. 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 drug is excreted mainly unchanged in the urine. No dose adjustment is necessary when administering a single dose. When multiple doses are required, administer the usual dose only on the first day, 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 Hemodialysis patients: 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 doses based on adult doses are generally determined according to the following guidelines 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 Safety and efficacy have not been established in infants under 6 months of age. Oropharyngeal candidiasis: Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue 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 (peritoneum, endocardium, lungs, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg on the first day, followed from the next day by 6 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue 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 completion of initial therapy. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

Precautions

This medication should not be administered to certain patients. Patients who are allergic to this medication or similar medications, pregnant or potentially pregnant women, and nursing mothers should not use this medication. Serious side effects may occur when taken with certain medications, so it should be avoided. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic conditions. Caution is needed when using this medication. Patients with a history of drug allergies, kidney or liver function problems, heart disease, or electrolyte disturbances that could lead to arrhythmias should consult a physician before taking this medication. Additionally, when taken with certain medications, dosage adjustments and monitoring may be necessary. While this medication is generally safe to use, serious side effects can rarely occur. For example, abnormalities related to blood, allergic reactions, liver dysfunction, skin rashes, and neurological symptoms have been reported. If severe rashes or systemic symptoms appear, medical help should be sought immediately. Regular blood tests, liver and kidney function tests, and electrolyte tests are recommended during the duration of this medication. If liver function declines significantly, the use of this medication should be reassessed. Patients at risk for cardiac arrhythmias require periodic monitoring through ECG. This medication can interact with numerous drugs, so it is essential to inform healthcare providers of any other medications being taken, especially those that may affect the heart, specific antibiotics, anticoagulants, antiepileptics, and immunosuppressants. Pregnant or nursing women should not use this medication, and women of childbearing age should implement effective contraception for the duration of treatment and at least one month after. The safety and efficacy of this medication in infants under 6 months have not been established, so it should be used only if absolutely necessary. Those driving or operating machinery should take care, as this medication may cause dizziness or seizures. In the event of an overdose, hallucinations or abnormal behavior may occur, and immediate medical assistance should be sought. This medication is primarily excreted through urine, so adequate hydration and, if necessary, blood dialysis can help eliminate it.

Side effects

Drug reaction with eosinophilia and systemic symptoms (DRESS), agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremors, 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, hepatic cell necrosis, hepatitis, hepatic cell damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, bizarre behavior

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is best kept in a cool room temperature, specifically between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy for a longer period and ensures its safe use.

Appearance and packaging

Appearance

A hard capsule with blue upper and white lower parts containing a white or pale yellow powder.

Package unit

28 capsules (14 capsules/blister X 2), 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.

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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.