FluRan Capsule (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. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. Oropharyngeal candidiasis: The usual dose of this medication is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose of this medication is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this medication is 50 mg once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this medication 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medication 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medication once daily indefinitely after the patient has completed all initial treatment. 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 medication once daily, depending on the patient's risk of developing a 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, who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg beginning 5-6 days before neutropenia is expected to occur, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 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 a new fingernail to grow and approximately 6-12 months for a toenail; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medication 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 infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. Patients with normal renal function generally receive the usual adult dose. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medication is excreted mainly in the urine unchanged. No dose adjustment is necessary when it is administered as a single dose. 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 > 50 mL/min: 100% of the usual dose Creatinine clearance ≤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.

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. The safety and efficacy have not been established in infants younger than 6 months. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): 6-12 mg/kg body weight once daily. The duration of treatment should be determined according to clinical response and medical judgment. Cryptococcal meningitis: 12 mg/kg body weight on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg body weight once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg body weight once daily after the patient has completed all initial treatment. Children with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, oral syrup or intravenous injection should be used, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. For instance, patients who have had allergic reactions to this medication or other azole drugs, women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. Moreover, some medications should not be taken together with this drug. For example, patients taking this medication in high doses who are also taking terfenadine may cause heart rhythm disturbances, and hence co-administration should be avoided. It should also not be taken with other drugs that prolong the QT interval, and patients with genetic conditions such as lactose intolerance should avoid using this medication. Caution should be taken in administering this medication to patients with kidney or liver issues, cardiac diseases, or electrolyte imbalances. Patients with a history of drug hypersensitivity should also use it with care. It is advisable to monitor the patient's condition regularly through liver and kidney function tests and blood tests while administering this medication. There have been reports of adrenal insufficiency, so caution should be taken in this regard. During the use of this medication, side effects such as headache, abdominal pain, diarrhea, vomiting, and rash may occur, and in rare cases, serious side effects such as liver dysfunction or cardiac arrhythmias may arise, so it is crucial to consult healthcare professionals if any unusual symptoms occur. This medication can interact with several other drugs, so if you are taking other medications, make sure to inform your healthcare provider, as some combinations may be prohibited or require dose adjustments. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age need to use effective contraception during and after a certain period post-therapy. For infants under 6 months of age, the safety of this medication has not been established, and it should only be administered cautiously when absolutely necessary. Precautions should be taken as dizziness or seizures may occur while driving or operating machinery. In cases of overdose, hallucinations or unusual behavior may be observed, and immediate medical attention should be sought. This medication is primarily excreted through urine, so in cases of overdose, blood dialysis may be used to reduce drug concentration.

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, 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, asthenia, fever, adrenal insufficiency, hallucinations, confusional behavior

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1°C to 30°C at room temperature. This will help to maintain the effectiveness and safety of the medication for a long time.

Appearance

Capsule filled with white powder, with a blue upper part and a white lower part.

Package unit

30 capsules/bottle, 100 capsules/bottle