Medication info
Fluconazole Capsule 150mg (Fluconazole)

Fluconazole Capsule 150mg (Fluconazole)

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

MFDS item code 201601131 · Approved 2016.02.29

Summary

Main use
Treatment of fungal infections (Candida, Cryptococcus, and cutaneous); treatment and prevention of recurrence of fungal infections
Who takes it
Adults
Adult dose
The route of administration should be determined according to the patient's clinical condition. Absorption of the oral formulation is rapid and nearly complete; therefore, the doses of the oral formulations (tablets, capsules, dry syrup) and the injectable formulation are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg as a single dose on the first day, followed by 200 mg once daily starting 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 is 400 mg as a single dose on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment should be determined by clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed initial treatment. 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 once daily according to the patient's degree of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those with severe or prolonged neutropenia, as may occur with bone marrow transplantation. In these 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 higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails generally take 3-6 months to grow, while toenails take approximately 6-12 months; growth rates may vary by individual and age. In some cases, the nails may remain damaged even 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. ○ Elderly patients If renal function is normal, the usual adult dose may be 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 medication is excreted primarily in the urine unchanged. Dose adjustment is not necessary for a single dose. For multiple-dose treatment, administer the usual dose only on the first day and adjust the dose from the following 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Hugens Co., Ltd.

Efficacy & effects

Treatment of fungal infections (Candida, Cryptococcus, and cutaneous); treatment and prevention of recurrence of fungal infections

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

This medication is used for gynecological fungal infections such as acute or recurrent vulvovaginal candidiasis. It is also effective for treating systemic candidiasis, including candidemia, disseminated candidiasis, and infections penetrating various sites such as the peritoneum, endocardium, lungs, and urinary tract. It is used for the treatment of cryptococcal meningitis and cryptococcosis in patients with weakened immune function, such as those with AIDS or organ transplant recipients. It also helps to prevent the recurrence of cryptococcosis in patients with AIDS. Additionally, this drug is used for the prevention of fungal infections in patients with neutropenia caused by cytotoxic chemotherapy, radiation therapy, and bone marrow transplantation. It is effectively used for treating various skin fungal infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. In summary, this medication is used for the prevention and treatment of fungal infections in various parts of the body.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Absorption of the oral formulation is rapid and nearly complete; therefore, the doses of the oral formulations (tablets, capsules, dry syrup) and the injectable formulation are the same. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg as a single dose on the first day, followed by 200 mg once daily starting 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 is 400 mg as a single dose on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment should be determined by clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent relapse of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed initial treatment. 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 once daily according to the patient's degree of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those with severe or prolonged neutropenia, as may occur with bone marrow transplantation. In these 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 higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails generally take 3-6 months to grow, while toenails take approximately 6-12 months; growth rates may vary by individual and age. In some cases, the nails may remain damaged even 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. ○ Elderly patients If renal function is normal, the usual adult dose may be 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 medication is excreted primarily in the urine unchanged. Dose adjustment is not necessary for a single dose. For multiple-dose treatment, administer the usual dose only on the first day and adjust the dose from the following 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 nondialysis days, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be administered to certain patients. First, individuals who have a history of allergies to this medication or similar drugs should not use it. It is also advisable that pregnant women or women who may become pregnant, as well as breastfeeding women, do not take this medication. Serious side effects may occur when taken with certain drugs, and it should not be combined without consulting a doctor. This medication contains lactose; therefore, individuals with genetic issues such as lactose intolerance should avoid taking it. Patients with kidney or liver dysfunction, and those with heart disease or at risk of arrhythmia should be particularly careful when using this medication. Also, since this medication inhibits enzymes that break down drugs in the liver, there are many drug interactions, so caution is needed when combining it with other medications during treatment. This drug is generally well tolerated, but gastrointestinal symptoms such as headaches, abdominal pain, diarrhea, nausea, and vomiting, as well as skin reactions such as rashes may occur. Rarely, serious side effects, including blood disorders, liver dysfunction, or cardiac arrhythmias, may occur, so if any unusual symptoms arise, you should consult a doctor immediately. Use of this medication should be avoided during pregnancy, especially in early pregnancy, as the risk of miscarriage or congenital malformations may increase. Nursing mothers should also refrain from taking this medication as it may pass into breast milk. This medication's safety for young children, especially infants under six months, has not been adequately confirmed, and must only be used cautiously when absolutely necessary. Caution is needed when driving or operating machinery as this medication may cause dizziness or seizures.

Side effects

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

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

Storage

Store this medication in a tightly closed container to protect it from air or moisture. It is recommended to maintain a room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Capsule with an upper part filled with white powder in dark blue and a lower part in light blue.

Package unit

30 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.

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.