Medication info
Flex Capsule 150 mg (Fluconazole)

Flex Capsule 150 mg (Fluconazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
Capsule filled with white powder, the upper part is dark blue, and the lower part is light blue.
Packaging
For domestic use - 30 capsules per bottle.
Approval status
Active

MFDS item code 201500754 · Approved 2015.02.16 · Insurance code 648602970

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment of cryptococcosis and suppression 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 (peritoneum, endocardium, lungs, 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 according to the patient's response. The duration of treatment is 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 is determined by 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 medicine once daily indefinitely after the patient has completed all 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 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 expected to have severe or prolonged neutropenia, as in bone marrow transplantation. 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 and continue treatment until the fingernails or toenails have regrown (until new, uninfected nails have grown). Fingernails generally take 3-6 months to regrow and toenails 6-12 months; growth rate may vary by age and individual. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. For dermatophyte infections of the skin, 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 disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose is administered. In the presence of 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 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 on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, reduce the dose according to creatinine clearance.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous fungal infections; 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
  • neutropenia
  • fungal infections
  • onychomycosis
  • athlete's foot
  • tinea corporis
View approved original text

This medication is used to treat acute or recurrent vulvovaginal candidiasis. It is also effective against systemic Candida infections such as candidemia and disseminated candidiasis. It treats cryptococcal meningitis in patients with normal immune function as well as in immunocompromised patients, and is used to prevent the recurrence of cryptococcosis in patients with AIDS. Additionally, it is effective in preventing fungal infections in patients with neutropenia due to cytotoxic chemotherapy, radiation therapy, and bone marrow transplantation. It is also used for dermatophyte infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. This drug is used effectively to 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. 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 (peritoneum, endocardium, lungs, 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 according to the patient's response. The duration of treatment is 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 is determined by 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 medicine once daily indefinitely after the patient has completed all 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 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 expected to have severe or prolonged neutropenia, as in bone marrow transplantation. 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 and continue treatment until the fingernails or toenails have regrown (until new, uninfected nails have grown). Fingernails generally take 3-6 months to regrow and toenails 6-12 months; growth rate may vary by age and individual. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. For dermatophyte infections of the skin, 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 disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose is administered. In the presence of 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 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 on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, reduce the dose according to creatinine clearance.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to this medication or similar compounds, pregnant or nursing women, and individuals taking specific medications should avoid this drug. This medication contains lactose, so it should not be administered to patients with lactose intolerance. Patients with kidney or liver function impairment, those at risk for heart disease or arrhythmias, need to use this medication with caution. This drug can interact with other medications, so if you are taking any other drugs, you must consult with your doctor or pharmacist. In rare cases, some patients may experience serious allergic reactions, liver damage, or blood abnormalities, so if any abnormal symptoms occur, you should immediately inform medical personnel. Pregnant women should not take this drug, and women of childbearing age should ensure effective contraception during and for a period after taking this drug. Lactating women are also advised to avoid taking this medication. Its safety has not been fully established in children, particularly infants under 6 months of age, so it should be used only when absolutely necessary. This drug may occasionally cause dizziness or seizures, so caution should be exercised while driving or operating machinery. In the event of an overdose, you should immediately visit a medical facility for appropriate treatment, and if necessary, blood dialysis may help remove the drug.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, 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, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute widespread pustular dermatitis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic 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 must be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. This helps maintain the medication's efficacy for an extended period.

Appearance and packaging

Appearance

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

Package unit

For domestic use - 30 capsules per 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.