Pavis Fluconazole Capsule 50mg (Fluconazole)

Adult dosage

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 (capsules, dry syrup) and injectable formulations are the same. 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, and urinary tract infections, etc.): The usual dose 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, after the patient has completed primary treatment, administer 200 mg once daily indefinitely. 6. 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 once daily according to the patient's degree of 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 beginning 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 above. 7. 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 6-12 months; the rate of growth 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 is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, in the case of athlete's foot, treatment for 6 weeks may be required depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. When 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. This medicine is excreted primarily unchanged in the urine. No dose adjustment is necessary 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 next day as follows. Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session In patients receiving hemodialysis, 100% of the usual dose should be administered after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

Adult dose 100 mg: pediatric dose 3 mg/kg Adult dose 200 mg: pediatric dose 6 mg/kg Adult dose 400 mg: pediatric dose 12 mg/kg Do not exceed 400 mg. Safety and efficacy have not been established in infants under 6 months of age (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer this medicine at 6 mg per kg of body weight on the first day, followed by 3 mg per kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer this medicine at 6 mg per kg of body weight on the first day, followed by 3 mg per kg of body weight once daily from the next day. The dose may be increased to 12 mg per kg of body weight once daily depending on the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg per kg of body weight once daily. Determine the treatment duration according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer this medicine at 12 mg per kg of body weight on the first day, followed by 6 mg per kg of body weight once daily from the next day. The dose may be increased to 12 mg per kg of body weight once daily depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg per kg of body weight once daily after the patient has completed all initial treatment. 6. For children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment, depending on the degree of renal impairment. When administering doses below 10 mg, give the oral syrup or intravenous injection according to the child's clinical condition to ensure accurate dosing.

This medication should not be used in certain patients. For instance, individuals allergic to this drug or similar medications, pregnant or potentially pregnant women, and nursing mothers should not take this drug. Moreover, patients taking certain medications should not take this drug concurrently. There are medications that can pose risks to the heart when taken with this drug, and in such cases, consultation with a healthcare professional is mandatory. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with kidney or liver problems, heart disease, or electrolyte abnormalities should be cautious when using this drug. Such patients should undergo regular check-ups to monitor their condition. Although this medication is generally well tolerated, it can rarely affect the blood, liver, kidneys, and may cause skin rashes or allergic reactions. If any unusual symptoms occur, immediately inform a healthcare professional. Especially patients with severe diseases should have regular blood tests and liver function tests while taking this medication, and if liver enzyme levels rise, the need for reevaluation of its usage should be considered. In pregnant or nursing women, this medication may harm the fetus or baby, hence it should be avoided, and women planning pregnancy should use effective contraception during and for at least one month after the period of taking this drug. Safety has not been established in infants under 6 months of age; thus, it should be used cautiously only when absolutely necessary. Dizziness or seizures may occur after taking this medication, so caution is necessary while driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, necessitating immediate medical attention to receive appropriate treatment, and if needed, hemodialysis may be performed to reduce drug concentration. This medication can interact with various other drugs, so it is essential to inform healthcare professionals of any other medications being taken for meticulous monitoring when combining medications.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte 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 reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, behavior disturbance

This drug is sensitive to air and humidity, so it should be stored in a tightly closed container. Additionally, it is best to store the drug at room temperature between 1 and 30 degrees Celsius.

Appearance

Hard capsule with the upper part filled with white powder that is blue in color and the lower part white.

Package unit

30 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle