Medication info

Diclonazole Capsule 150 mg (Fluconazole)

Prescription medicationExpired
Ingredient · strength
Fluconazole›Strength being verified
Manufacturer / importer
Donggu Bio Pharmaceutical Co., Ltd.
Appearance
Capsule filled with white powder, dark blue upper part and light blue lower part
Packaging
30 capsules/bottle
Approval status
Expired

MFDS item code 200706873 · Notified 2007.06.15

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of candidiasis and dermatomycosis; treatment of cryptococcosis and suppression of recurrence; prevention of fungal infections
Who uses it
Adults
Adult dosage
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 as fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug 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 clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment depends on 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 drug once daily indefinitely after the patient has completed primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this drug 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 infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg starting 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 higher. 6. 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 about 6-12 months; growth rates may vary by individual and age. Occasionally, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris (jock itch), and cutaneous candidiasis: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, tinea pedis may require treatment for 6 weeks depending on the course. 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 drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose. 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 receiving 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
Donggu Bio Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Acute vulvovaginal candidiasis
  • recurrent vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • fungal infections
  • onychomycosis
  • athlete's foot
  • tinea corporis
  • tinea cruris
View approved original text

This medication is used to treat acute or recurrent vulvovaginal candidiasis. It is also effective for systemic candidal infections such as candidemia and disseminated candidiasis. It is utilized for the treatment of cryptococcal meningitis and other cryptococcal infections in both immunocompetent patients and immunocompromised patients. It is also used as maintenance therapy to prevent recurrent cryptococcosis in patients with AIDS. Additionally, it helps prevent fungal infections in immunocompromised patients due to cytotoxic chemotherapy or bone marrow transplantation. It is effective against dermatophyte infections such as athlete's foot, onychomycosis, and tinea corporis, thus treating various fungal infections.

Dosage and Administration

Adult dosage

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 as fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug 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 clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment depends on 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 drug once daily indefinitely after the patient has completed primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this drug 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 infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg starting 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 higher. 6. 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 about 6-12 months; growth rates may vary by individual and age. Occasionally, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris (jock itch), and cutaneous candidiasis: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, tinea pedis may require treatment for 6 weeks depending on the course. 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 drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose. 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 receiving 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 certain patients. For example, it should not be administered to patients with allergies to this drug or similar classes, nor to pregnant or nursing women. Additionally, it should be avoided in patients with certain heart conditions or arrhythmias and those taking specific medications. This medication contains lactose and should not be used in patients with lactose intolerance or related genetic disorders. When using this medication, it should be administered with caution in patients with renal or liver function issues, cardiac diseases, and a history of drug allergies. Special caution is necessary for patients with liver dysfunction, as it can worsen liver function. This drug inhibits various enzymes that metabolize in the liver, leading to numerous drug interactions, thus caution is needed when used in combination with other medications, especially those that may affect the heart. If combined use is inevitable, thorough management and monitoring by the healthcare provider are required. This medication generally has good tolerability; however, it can rarely affect blood, liver, and kidney functions, and can cause skin rashes, liver damage, and cardiac arrhythmias. If abnormal symptoms occur, inform the healthcare provider immediately. Pregnant women should avoid this medication as it may increase the risk of congenital malformations or miscarriage in the fetus. Women of childbearing age should ensure effective contraception during and for about one month after treatment. Nursing mothers should avoid administration as this drug can be secreted in breast milk. The safety for children, especially infants under 6 months, has not been established, thus it should only be administered with caution if absolutely necessary. During treatment, dizziness or seizures may occur, hence caution should be taken while driving or operating machinery. In cases of overdose, hallucinations or abnormal behaviors may occur, and symptomatic treatment like gastric lavage may be necessary. As this drug is primarily excreted via urine, adequate hydration and hemodialysis may be beneficial.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, face edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

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 it from air and moisture and kept at room temperature between 1°C and 30°C. This will help to maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

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