Medication info
Dikaol 150 mg tablet (Fluconazole)

Dikaol 150 mg tablet (Fluconazole)

Prescription medicationTabletOral
Ingredient · strength
Fluconazole›150mg / 1 tablet
Manufacturer / importer
NEXPAM KOREA Co., Ltd.
Appearance
Pink oblong tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201903405 · Approved 2019.05.24 · Insurance code 662504230

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections, treatment and prevention of recurrence of cryptococcosis, prevention of fungal infections
Who takes it
Adults
Adult dose
The route of administration should be determined according to the patient's clinical condition. Since absorption of the oral formulations is rapid and almost complete, the doses of oral formulations (tablets, capsules, dry syrup) and the injectable formulation 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.): Usually administer 400 mg of this drug as a single dose on the first day, followed from the next day by 200 mg once daily. The dose may be increased to up to 400 mg once daily depending on the patient's response. The duration of administration should be determined according to the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: Usually administer 400 mg of this drug as a single dose on the first day, followed from the next day by 200-400 mg once daily. The duration of treatment should be determined by the clinical and mycological response, but treatment should generally be continued 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 all initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to the patient's degree of risk of developing a 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 have severe neutropenia or are expected to have 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 more. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: Usually administer 50 mg of this drug once daily or 150 mg once weekly for 2-4 weeks. However, in cases of athlete's foot, treatment for 6 weeks may be necessary 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 generally administered. If renal impairment is present (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 mainly in the urine unchanged. No dose adjustment is necessary for a single dose, but if multiple doses are required, administer the usual dose only on the first day of treatment 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 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
NEXPAM KOREA Co., Ltd.

Efficacy & effects

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

  • Acute vulvovaginal candidiasis
  • recurrent vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • neutropenia
  • fungal infections
  • onychomycosis
  • tinea
  • tinea corporis
View approved original text

This medication is used to treat various fungal infections. It is effective in treating various forms of candidiasis, including acute or recurrent vulvovaginal candidiasis. It is also used for the treatment of severe fungal infections such as systemic candidiasis. It is suitable for maintenance therapy to prevent recurrence of cryptococcosis in patients with weakened immune systems and those with AIDS. It also helps in preventing fungal infections in patients whose immunity is reduced due to cytotoxic chemotherapy or radiation therapy. Additionally, it is used to treat skin fungal infections such as onychomycosis and tinea corporis. Overall, this drug is used to effectively treat and prevent various fungal infections.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Since absorption of the oral formulations is rapid and almost complete, the doses of oral formulations (tablets, capsules, dry syrup) and the injectable formulation 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.): Usually administer 400 mg of this drug as a single dose on the first day, followed from the next day by 200 mg once daily. The dose may be increased to up to 400 mg once daily depending on the patient's response. The duration of administration should be determined according to the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: Usually administer 400 mg of this drug as a single dose on the first day, followed from the next day by 200-400 mg once daily. The duration of treatment should be determined by the clinical and mycological response, but treatment should generally be continued 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 all initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to the patient's degree of risk of developing a 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 have severe neutropenia or are expected to have 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 more. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: Usually administer 50 mg of this drug once daily or 150 mg once weekly for 2-4 weeks. However, in cases of athlete's foot, treatment for 6 weeks may be necessary 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 generally administered. If renal impairment is present (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 mainly in the urine unchanged. No dose adjustment is necessary for a single dose, but if multiple doses are required, administer the usual dose only on the first day of treatment 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 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 given to certain patients. For example, patients who have had an allergic reaction to this drug or other similar medications, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Additionally, patients who are taking certain medications, such as terfenadine, cisapride, astemizole, or erythromycin, may experience severe side effects when using this drug, so they should not use it. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. There are also patients who need to be cautious when using this drug. For instance, patients with a history of drug allergies or with renal or liver function issues, as well as those at risk for heart disease or arrhythmias should use this drug carefully. Moreover, since this drug inhibits several enzymes that are metabolized in the liver, there is a potential for drug interactions, and careful observation of concomitant medications is necessary. While taking this medication, various adverse reactions may occur. Headaches, dizziness, indigestion, rash, and liver function abnormalities have been reported, with rare cases of severe blood abnormalities, cardiac arrhythmias, or severe skin reactions possibly occurring. Therefore, if these symptoms appear, immediate consultation with a healthcare professional is necessary. This medication can particularly affect liver and kidney function, so blood tests and liver and kidney function tests are recommended before and during administration. Additionally, patients with heart-related conditions or electrolyte imbalances should be cautious and confirm QT interval prolongation by performing an ECG. This drug has the potential to interact with various other medications, so if other medications are being taken, it is essential to inform healthcare professionals, as some drugs may have contraindications or require dosage adjustments. Women who are pregnant or planning to become pregnant should not take this medication, and they should use effective contraception during the treatment period and for some time afterward. It is also safer for breastfeeding women to avoid this medication. The safety of this medication for infants under 6 months old has not been established, so it should not be administered unless under special circumstances. This medication can sometimes cause dizziness or seizures, so caution is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors may occur, so immediate medical attention should be sought for appropriate treatment. Supportive care and, if necessary, gastric lavage or hemodialysis may be beneficial in cases of overdose.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, xerostomia, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, elevated bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular injury, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reactions accompanied by 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. It is advisable to maintain storage temperatures between 1 degree to 30 degrees Celsius at room temperature. Proper storage will ensure the safety and efficacy of the medication.

Appearance and packaging

Appearance

Pink oblong tablet

Package unit

30 tablets/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.