Medication info

In Phican Capsule 150 mg (Fluconazole)

Prescription medicationOralExpired
Ingredient · strength
Fluconazole›150mg / 1 capsule
Manufacturer / importer
TaeGeuk Pharmaceutical Co., Ltd.
Appearance
A capsule with a dark blue upper part and a light blue lower part containing a white powder.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 201905831 · Approved 2019.08.19

This product's status changed to Expired on 2024.08.19. 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 fungal skin infections; prevention of fungal infections and recurrence
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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug 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 based on 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 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 drug once daily indefinitely after completion of primary 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 drug 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these 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 fingernail or toenail has regrown (until an uninfected new nail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary between individuals and with age. In some cases, the nails may remain damaged 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 of this drug 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 clinical course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, administer the usual adult dose. If renal impairment is present (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. Dose adjustment is not necessary for a single dose, but when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as shown below. 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
TaeGeuk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medicine is used for the treatment of acute or recurrent vaginal candidiasis. It is also effective in treating invasive Candida infections such as candidemia and systemic candidiasis. It is used for treating cryptococcal meningitis and other cryptococcosis in patients with impaired immune function, including AIDS patients and organ transplant recipients. Additionally, it serves as a maintenance therapy to prevent the recurrence of cryptococcosis in AIDS patients. Furthermore, it helps prevent fungal infections in patients with neutropenia due to cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation. Finally, it is used to treat various dermatophytosis, including onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis.

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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug 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 based on 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 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 drug once daily indefinitely after completion of primary 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 drug 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 bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these 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 fingernail or toenail has regrown (until an uninfected new nail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary between individuals and with age. In some cases, the nails may remain damaged 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 of this drug 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 clinical course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, administer the usual adult dose. If renal impairment is present (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. Dose adjustment is not necessary for a single dose, but when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as shown below. 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 medicine should not be administered to certain patients. For example, pregnant or breastfeeding women or those allergic to this drug or similar medications should not take it. Additionally, patients with certain heart conditions or arrhythmias, as well as those taking other drugs that have severe interactions with this medicine, should exercise caution. This medicine should be used carefully in patients with impaired kidney or liver function, especially since liver function may worsen; monitoring liver enzyme levels is important. Patients with heart disease or electrolyte imbalances are also at risk of arrhythmias while taking this medication, so caution is advised. In general, this medicine is well tolerated, but rare side effects can include blood abnormalities, allergic reactions, liver function abnormalities, skin rashes, headaches, gastrointestinal disturbances, bloating, dry mouth, itching, increased sweating, drug rashes, muscle pain, fatigue, malaise, and weakness, fever. Pregnant women or those who may become pregnant should avoid pregnancy during and for a period after taking this medication, and it is not recommended for use in pregnant women. Breastfeeding women should also avoid taking this drug. This medication may interact with various drugs; therefore, if you are taking other medications, inform your doctor or pharmacist. Caution is especially necessary when taking this medication with drugs that may affect the heart, anticoagulants, antiepileptics, immunosuppressants, etc. Children, especially infants under 6 months of age, have not established safety and efficacy, so it should only be used when necessary. During the usage of this medicine, caution is required as dizziness and seizures may occur while driving or operating machinery. In the event of an overdose, hallucinations or unusual behavior may occur, necessitating immediate medical attention. This drug is primarily excreted in urine and may be partially removed by dialysis.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, 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, 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, weakness, fever, adrenal insufficiency, hallucinations, oppositional 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 should be stored in a tightly sealed container. Also, it is safe to store the medication at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

A capsule with a dark blue upper part and a light blue lower part containing a white powder.

Package unit

30 capsules/bottle, 100 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.

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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.