Medication info
Funazol M Tablet 150 mg (Fluconazole)

Funazol M Tablet 150 mg (Fluconazole)

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

MFDS item code 201906580 · Approved 2019.09.19 · Insurance code 622804110

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections, treatment of cryptococcosis and prevention 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 rapidly and almost completely absorbed; 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400 mg once on the first day, followed from the next day by 200 mg once daily. 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 the 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 from the next day by 200-400 mg once daily. The duration of treatment is determined by the clinical and mycological response, but treatment should generally 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 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, depending on 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 undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In such patients, administer 400 mg starting 5-6 days before the anticipated 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 uninfected new nails have grown). New fingernails generally take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary from person to person and with age. In some cases, the fingernails or toenails may remain damaged even 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: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks depending on the course of the condition. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults 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 mainly in the urine unchanged. No dosage adjustment is necessary when administering a single dose; however, when multiple doses are required, administer the usual dose only on the first day 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
Mother's Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous fungal infections, treatment of cryptococcosis and prevention 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 for acute or recurrent vulvovaginal candidiasis, systemic candidiasis (in various locations such as blood, peritoneum, endocardium, lungs, urinary tract, etc.), and cryptococcal meningitis and other infections caused by cryptococcus in patients with normal immune function and those with immunocompromised conditions. It is also effective for prophylactic maintenance therapy to prevent the recurrence of cryptococcosis in AIDS patients. It helps prevent fungal infections in patients with immunosuppressed conditions due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. Lastly, it is used for the treatment of skin fungal infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and skin candidiasis. It effectively acts on various fungal infections, improving patients' symptoms.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Oral formulations are rapidly and almost completely absorbed; 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400 mg once on the first day, followed from the next day by 200 mg once daily. 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 the 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 from the next day by 200-400 mg once daily. The duration of treatment is determined by the clinical and mycological response, but treatment should generally 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 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, depending on 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 undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In such patients, administer 400 mg starting 5-6 days before the anticipated 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 uninfected new nails have grown). New fingernails generally take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary from person to person and with age. In some cases, the fingernails or toenails may remain damaged even 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: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks depending on the course of the condition. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults 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 mainly in the urine unchanged. No dosage adjustment is necessary when administering a single dose; however, when multiple doses are required, administer the usual dose only on the first day 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 medication is an azole antifungal agent used for the treatment of fungal infections. Firstly, patients who have hypersensitivity or allergies to azole medications should not use this medication. Pregnant women or women who may become pregnant, as well as nursing mothers, should avoid this medication. In addition, severe side effects may occur when taken with specific medications, so it should not be used in combination with terfenadine, cisapride, astemizole, erythromycin, and others. Patients with lactose intolerance or hereditary lactose degradation enzyme deficiency should also refrain from using this medication. Patients with kidney or liver function issues need to be cautious when taking this medication, as liver function may worsen, requiring regular check-ups. Patients with heart disease or electrolyte imbalances should exercise caution due to the risk of heart rhythm disturbances caused by this medication. This medication can interact with several other drugs, so if any other medications are currently being taken, it is essential to inform the doctor or pharmacist, and dosage adjustments or monitoring may be necessary. This medication is generally well tolerated; however, rare side effects such as blood abnormalities, liver damage, skin rash, and cardiac arrhythmias may occur, so if any unusual symptoms arise, immediate consultation with medical personnel is recommended. During pregnancy, there may be an increased risk of miscarriage or congenital abnormalities, so it should be avoided if planning a pregnancy or during pregnancy. Effective contraception should be used for one month after the last dose. Nursing mothers are also advised to avoid breastfeeding while taking this medication. Safety in children, particularly in infants under 6 months of age, has not been established, so it should be administered cautiously and only when necessary. Dizziness or seizures may occur while driving or operating machinery, requiring careful attention. In cases of overdose, hallucinations or abnormal behavior may occur, requiring immediate medical treatment, and supportive care, gastric lavage, and dialysis may be necessary to remove the drug.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade 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, hepatic toxicity, 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, facial swelling, hair loss, drug reaction with eosinophilia and systemic symptoms (DRESS), myalgia, fatigue, malaise, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. The storage temperature should be kept between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink oblong tablets

Package unit

30 tablets/bottle - 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.