Medication info
Fluconazole 150 mg Tablets (Fluconazole)

Fluconazole 150 mg Tablets (Fluconazole)

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

MFDS item code 201306383 · Approved 2013.03.22 · Insurance code 653402770

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment and prevention of recurrence of cryptococcosis; prevention of fungal infections
Who takes it
Adults
Adult dose
The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, 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 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 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 usually continue 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 primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection 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 infection, such as those with severe neutropenia or an expected prolonged period of 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 until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for new fingernails to grow and 6-12 months for toenails; growth rate may vary among individuals according to age. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous 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, treatment of athlete's foot may need to continue for 6 weeks, depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, administer the usual adult dose. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. Dose adjustment is not necessary when administering 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) > 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 For patients receiving hemodialysis, administer 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
Dongguk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of acute or recurrent vaginal candidiasis. It is also effective in treating systemic candidiasis including candidemia and disseminated candidiasis. It is used for the treatment of cryptococcal meningitis and other cryptococcal infections in immunocompromised patients. It is also utilized as maintenance therapy to prevent recurrence of cryptococcal infections in AIDS patients. It helps in the prevention of infections in patients at risk of fungal infections due to reduced immune function. It is also used for the treatment of various dermatophyte infections such as onychomycosis, tinea pedis, tinea corporis, and tinea cruris. In summary, this medicine is effectively used for the treatment and prevention of various fungal infections.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, 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 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 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 usually continue 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 primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection 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 infection, such as those with severe neutropenia or an expected prolonged period of 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 until the fingernails or toenails have regrown (until new, uninfected nails have grown). It usually takes 3-6 months for new fingernails to grow and 6-12 months for toenails; growth rate may vary among individuals according to age. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term administration. For cutaneous 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, treatment of athlete's foot may need to continue for 6 weeks, depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, administer the usual adult dose. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. Dose adjustment is not necessary when administering 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) > 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 For patients receiving hemodialysis, administer 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 agent and should not be administered to certain patients. Patients allergic to this drug or similar drugs, as well as pregnant or possibly pregnant women, and breastfeeding women should not use this drug. Additionally, it should be avoided in combination with certain medications due to the risk of severe side effects. This drug contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. This drug should be administered cautiously in patients with impaired renal or liver function, heart disease, or at risk of arrhythmia. Patients with a history of drug hypersensitivity should also be cautious. This drug may affect liver function, so regular liver function tests should be conducted to monitor the condition. Generally, this drug is well tolerated, but various side effects such as blood abnormalities, allergic reactions, neurological symptoms, gastrointestinal disturbances, liver damage, and skin rashes may occur rarely. Particularly, due to the risk of liver toxicity or cardiac arrhythmia, you should consult medical professionals immediately if any abnormal symptoms occur. This drug has many drug interactions, requiring dose adjustments or monitoring when used in combination. Special caution is needed when used with medications affecting the heart, anticoagulants, certain antibiotics, anticonvulsants, immunosuppressants, and calcium channel blockers. You should inform your doctor or pharmacist about all medications you are currently taking to check for interactions. During pregnancy, the use of this medication should be avoided, especially in the early stages of pregnancy, as the risk of miscarriage or congenital malformations may increase. Women of childbearing age should ensure effective contraception during and after the use of this drug for a certain period. Breastfeeding is also discouraged as this drug is excreted into breast milk. Safety in infants under 6 months of age has not been established, thus it should only be used cautiously when absolutely necessary. Caution is required when driving or operating machinery, as this medication may cause dizziness or seizures. In case of overdose, hallucinations or abnormal behaviors may occur, and immediate medical attention should be sought. This drug is primarily excreted in urine, so adequate hydration and, if necessary, hemodialysis may be helpful.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, tremors, vertigo, Torsade 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, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, aggressive behavior

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

Storage

This drug may be sensitive to air or moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius (room temperature). This will help preserve the drug's effectiveness safely.

Appearance and packaging

Appearance

Pink rectangular tablet

Package unit

30 tablets/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.