Medication info

Pavis Fluconazole Capsules 150 mg

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

MFDS item code 201906110 · Approved 2019.08.28

This product's status changed to Expired on 2024.08.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of candidiasis, cryptococcosis, and dermatophytosis; 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 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 fluconazole 150 mg orally as a single dose. 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 400mg once on the first day, followed by 200mg once daily from the next day; the dose may be increased to 400mg once daily according to the patient's response. The duration of treatment is determined by clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400mg once on the first day, followed by 200 ~ 400mg 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 200mg of this medicine once daily indefinitely after the patient has completed initial therapy. 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~ 400mg of this medicine once daily, depending on the patient's risk of fungal infection. A dose of 400mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400mg beginning 5-6 days before the expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000cells/mm3 or more. 6. For onychomycosis, administer 150 mg once weekly; continue treatment until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; the growth rate may vary by individual and age. In some cases, fingernails or toenails 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 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 of the disease. For tinea versicolor, administer 50mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. 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. No dose adjustment is necessary for a single dose; however, if multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the following 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 regular dialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session; on nondialysis days, the dose should be reduced according to creatinine clearance.

Ingredients

Manufacturer
Pavis Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of candidiasis, cryptococcosis, and dermatophytosis; prevention of fungal infections and recurrence

  • Acute vaginal candidiasis
  • recurrent vaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • fungal infections
  • neutropenia
  • onychomycosis
  • athlete's foot
  • body ringworm
View approved original text

This medication is used for the treatment of acute or recurrent vaginal candidiasis, systemic candidiasis (including candidemia and disseminated candidiasis), as well as cryptococcal meningitis and other infections occurring in patients with normal immune function and those with compromised immunity. It also aids in preventing recurrence of cryptococcal disease in AIDS patients, and in preventing fungal infections in immunosuppressed patients. It is effective for the treatment of various skin fungal infections, including dermatophyte infections, tinea, body ringworm, athlete's foot, tinea versicolor, and skin candidiasis. It is broadly used for a variety of fungal infections, improving fungal infection conditions.

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 fluconazole 150 mg orally as a single dose. 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 400mg once on the first day, followed by 200mg once daily from the next day; the dose may be increased to 400mg once daily according to the patient's response. The duration of treatment is determined by clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400mg once on the first day, followed by 200 ~ 400mg 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 200mg of this medicine once daily indefinitely after the patient has completed initial therapy. 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~ 400mg of this medicine once daily, depending on the patient's risk of fungal infection. A dose of 400mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. In these patients, administer 400mg beginning 5-6 days before the expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000cells/mm3 or more. 6. For onychomycosis, administer 150 mg once weekly; continue treatment until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; the growth rate may vary by individual and age. In some cases, fingernails or toenails 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 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 of the disease. For tinea versicolor, administer 50mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. 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. No dose adjustment is necessary for a single dose; however, if multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the following 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 regular dialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session; on nondialysis days, the dose should be reduced according to creatinine clearance.

Precautions

This medication should not be used in certain patients. For example, people who are allergic to this medication or similar drugs, pregnant women or those who may become pregnant, and breastfeeding individuals should not take this medication. Additionally, patients taking certain medications should not take this medication simultaneously. In particular, medications that may affect the heart, certain antibiotics, and drugs that could influence heart rhythm should not be combined with this medication. Individuals with genetic issues like lactose intolerance should also avoid this medication. Patients with kidney or liver function issues need to exercise caution when using this medication, as well as individuals with heart diseases or electrolyte abnormalities should be careful. This medication can interact with various drugs; therefore, it is crucial to consult a doctor or pharmacist if taking other medications. It is important to regularly monitor liver function, kidney function, and conduct blood tests during the course of taking this medication to check for any abnormalities. Furthermore, this medication can occasionally cause severe side effects, so if symptoms such as rash, difficulty breathing, heart palpitations, severe abdominal pain, or jaundice occur, immediate medical attention should be sought. It is safest for pregnant or breastfeeding women not to take this medication and women of child-bearing potential should use effective contraception during the treatment period and for some time after. The safety of this medication has not been established in children, particularly infants under 6 months old, so it should only be used when strictly necessary. When driving or operating machinery, caution should be observed as dizziness or seizures may occur after taking this medication. Lastly, in case of overdose, hallucinations or unusual behavior may occur, so it is essential to adhere to the prescribed dosage and to contact a medical facility immediately if an overdose happens.

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 distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocyte 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 reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, behavioral disturbances

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 closed container. Additionally, the medication should be kept at room temperature, avoiding extremes of heat or cold, preferably between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

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

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.