Medication info

Diflucan 150 mg (Fluconazole)

Prescription medicationExpired
Ingredient · strength
Fluconazole›Strength being verified
Manufacturer / importer
Pharmaking Co., Ltd.
Appearance
Pink rectangular tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 200611095 · Notified 2006.08.03

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 cryptococcosis; treatment of cutaneous fungal infections; prevention of fungal infections and recurrence
Who uses it
Adults
Adult dosage
The route of administration should be determined according to the patient's clinical condition. Because oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single 150 mg oral dose 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 medicine is 400 mg once on the first day, followed from the next day by 200 mg once daily; depending on the patient's response, the dose may be increased to 400 mg once daily. 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 medicine 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 be given for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after the patient has completed primary treatment, administer 200 mg of this medicine once daily indefinitely. 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, depending on 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 undergoing bone marrow transplantation with severe neutropenia or an expected prolonged period of 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 increases to 1,000 cells/mm3 or higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails regrow (until new, uninfected nails grow). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary by individual and age. In some cases, even after successful treatment with long-term administration, the fingernails or toenails may remain damaged. For skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine 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. 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 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose; however, when multiple doses are required, 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 ≤50 (not on dialysis) Patients on hemodialysis 100% of the usual dose 50% of the usual dose 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 without dialysis, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Pharmaking Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat acute or recurrent vulvovaginal candidiasis. It is also effective against systemic candidal infections, including candidemia and disseminated candidiasis. It is utilized in the treatment of cryptococcal meningitis and cryptoccoccosis in immunocompetent patients as well as in those with immunocompromised conditions. In AIDS patients, it serves as maintenance therapy to prevent the recurrence of cryptococcosis. Additionally, it helps to prevent fungal infections in immunocompromised patients. Lastly, it is used to treat skin fungal infections such as onychomycosis, tinea pedis, tinea corporis, and cutaneous candidiasis.

Dosage and Administration

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single 150 mg oral dose 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 medicine is 400 mg once on the first day, followed from the next day by 200 mg once daily; depending on the patient's response, the dose may be increased to 400 mg once daily. 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 medicine 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 be given for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after the patient has completed primary treatment, administer 200 mg of this medicine once daily indefinitely. 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, depending on 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 undergoing bone marrow transplantation with severe neutropenia or an expected prolonged period of 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 increases to 1,000 cells/mm3 or higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails regrow (until new, uninfected nails grow). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary by individual and age. In some cases, even after successful treatment with long-term administration, the fingernails or toenails may remain damaged. For skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine 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. 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 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 medicine is excreted mainly in the urine unchanged. No dose adjustment is needed for a single dose; however, when multiple doses are required, 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 ≤50 (not on dialysis) Patients on hemodialysis 100% of the usual dose 50% of the usual dose 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 without dialysis, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be administered to certain patients. For example, it should not be used by patients who have had hypersensitivity reactions to this medication or other azole medications, women who are pregnant or may become pregnant, and nursing mothers. Moreover, serious side effects may occur when taken with certain medications, so patients on these medications should also avoid this drug. This medication contains lactose; therefore, it should not be administered to patients with lactose intolerance or related genetic disorders. It should be used cautiously in patients with impaired kidney or liver function, a history of drug hypersensitivity, heart disease, or electrolyte disturbances that may pose a risk for arrhythmias. In addition, since this medication strongly inhibits certain enzymes, caution is required when used with other medications metabolized by these enzymes, and the patient's condition should be closely monitored. Generally, this drug is well tolerated, but in rare cases, abnormalities in blood, liver, or kidney functions may occur, and skin rashes or serious skin reactions may develop. Also, side effects such as headache, dizziness, dyspepsia, abdominal pain, diarrhea, and vomiting may occur, so if symptoms are severe, consult a physician. During pregnancy, the use of this medication might be harmful to the fetus; thus, women planning to become pregnant or who are pregnant should avoid its use and effective contraception should be practiced during treatment. In the case of nursing, since this medication is excreted in breast milk, it is advisable not to use it. Safety regarding infants, particularly those under 6 months of age, has not been established, and it should be used cautiously only if necessary. Dizziness or seizures may occur while taking this medication, so caution is advised when driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may manifest, so immediate medical attention should be sought, and if necessary, hemodialysis can be used to lower the serum concentration of this medication.

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, abdominal bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular 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, 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 and should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1°C and 30°C to safely preserve the efficacy of the medication.

Appearance and packaging

Appearance

Pink rectangular 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.