Medication info

Aju Fluconazole Capsule 150 mg

Prescription medicationExpired
Ingredient · strength
Fluconazole›Strength being verified
Manufacturer / importer
Aju Pharmaceuticals Co., Ltd.
Appearance
A capsule filled with white powder, the upper part is dark blue and the lower part is light blue.
Packaging
Company packaging unit
Approval status
Expired

MFDS item code 200706780 · Notified 2007.06.12

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 prevention 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) / Recommended dose > 50 / 100 % of the usual dose ≤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
Aju Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication is effective for the treatment of acute and recurrent vulvovaginal candidiasis. It is also used to treat candidemia, disseminated candidiasis, and invasive candidal infections occurring in various sites such as the peritoneum, endocardium, lungs, and urinary tract. It is effective for treating cryptococcal meningitis and other infections in immunocompromised individuals, including those with HIV/AIDS and organ transplant recipients. It is especially used as maintenance therapy for preventing the recurrence of cryptococcosis in AIDS patients. Additionally, it helps prevent fungal infections in patients with neutropenia following chemotherapy or radiation therapy. It is also utilized for the treatment of various dermatophyte infections such as onychomycosis, tinea pedis, tinea corporis, tinea cruris, pityriasis, and cutaneous candidiasis. In summary, this medication is used for the treatment and prevention of various forms of candidiasis and cryptococcosis, as well as for improving various dermatophyte 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) / Recommended dose > 50 / 100 % of the usual dose ≤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 drug is an azole antifungal used to treat fungal infections. This medication should not be used in certain patients. For example, patients who are allergic to this drug, its excipients, or other azole drugs, pregnant women or women who may become pregnant, and breastfeeding women should not take this drug. Also, it should be avoided by patients taking certain medications as it may be dangerous, including terfenadine, cisapride, astemizole, erythromycin, pimobendan, quinidine, and ergots. This drug contains lactose, so it should not be administered to patients with lactose intolerance or related genetic diseases. Patients with a history of drug hypersensitivity, impaired renal or liver function, or those with heart disease or electrolyte disorders should use this drug cautiously. Special caution is required if there is a risk of cardiac arrhythmia. This medication may affect liver and kidney function, so blood tests, liver function tests, kidney function tests, and electrolyte tests are recommended before and during administration. This drug can interact with various medications, so if other medications are being taken, it is essential to inform a doctor or pharmacist, and dosage adjustments or monitoring may be necessary depending on the medications taken. Pregnant women should avoid taking this medication as it may harm the fetus, and women of childbearing potential should use contraception during the treatment period and for about one month after the last dose. Breastfeeding women should also avoid taking this medication, as it may be transmitted through breast milk. Safety has not been established for infants under 6 months, so it should be used cautiously only if absolutely necessary. Caution should be taken when driving or operating machinery after taking this medication, as dizziness or seizures may occur. In case of overdose, symptoms may include hallucinations or unusual behavior, and immediate consultation with medical personnel is advised for appropriate treatment. This drug is primarily excreted in urine, so in cases of overdose, blood dialysis may be used to reduce drug concentration.

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, elevated ALT, elevated AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial swelling, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, agitated behavior

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

Storage

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1°C and 30°C. This will help keep the medication effective and safe for a long time.

Appearance and packaging

Appearance

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

Package unit

Company packaging unit

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.