Medication info
Dirocan Capsule 150 mg (Fluconazole)

Dirocan Capsule 150 mg (Fluconazole)

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

MFDS item code 201801366 · Approved 2018.03.28 · Insurance code 649405110

Summary

Main use
Treatment of candidiasis and skin 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. 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 a single oral dose of 150 mg of fluconazole. 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 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 depending on the patient's response. The duration of treatment should be determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment should be determined based on clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. 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. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to 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 infections, 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 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 uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary by individual and age. 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 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 infection. 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary when administered as a single dose. If 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 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.

Ingredients

Manufacturer
Yeongil Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Acute vulvovaginal candidiasis
  • recurrent vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • systemic candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • fungal infections
  • dermatophytosis
  • onychomycosis
  • tinea pedis
View approved original text

This medication is used to treat acute or recurrent vulvovaginal candidiasis. It also assists in the treatment of systemic candidiasis such as candidemia, disseminated candidiasis, and cryptococcal meningitis and other cryptococcal infections that may occur in immunocompromised patients. It is also used as maintenance therapy to prevent relapse of cryptococcosis in AIDS patients. It is used to prevent fungal infections in patients with neutropenia due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplants. Additionally, it is effective in treating various skin fungal infections including onychomycosis, tinea pedis, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. Overall, it is used for the treatment and prevention of various diseases related to 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 a single oral dose of 150 mg of fluconazole. 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 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 depending on the patient's response. The duration of treatment should be determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment should be determined based on clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. 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. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to 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 infections, 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 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 uninfected new nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary by individual and age. 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 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 infection. 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary when administered as a single dose. If 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 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.

Precautions

This medication should not be used in patients who are allergic to specific drugs or ingredients. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Patients who are on specific medications along with this drug should consult a doctor, as the combination may pose risks. Patients with lactose intolerance or certain genetic metabolic disorders may find this medication harmful to their health. Caution is needed in patients with kidney or liver problems, as there is a risk of liver function deterioration. Patients with heart conditions or electrolyte abnormalities should be cautious as they may experience cardiac issues such as arrhythmias. Regular checks of liver and kidney function and blood tests are recommended while taking this medication. This medication may interact with other drugs, so healthcare providers should be consulted regarding concomitant medications. Taking this medication during pregnancy may increase the risk of congenital malformations or miscarriage, thus it is advised to avoid use during this period. For nursing mothers, since it can pass into breast milk and affect the baby, it is also safer to refrain from taking it. In infants younger than 6 months, safety has not been fully established, so it should be used with caution. This medication may occasionally cause side effects such as headaches, digestive issues, rashes, or liver function abnormalities; if any unusual symptoms occur, consultation with a doctor is essential. In cases of overdose, symptoms such as hallucinations or behavioral changes may occur, and appropriate treatment should be obtained if necessary. Caution is also advised when driving or operating machinery, as dizziness or seizures may occur due to this medication.

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, 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 generalised exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, aggressive 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 sealed container. It is best kept at room temperature between 1 to 30 degrees Celsius to maintain its efficacy and safety for a longer time.

Appearance and packaging

Appearance

A capsule with the upper part filled with white powder in dark blue and the lower part in light blue.

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.

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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.