Fluconazole Capsule 50 mg

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. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days, and treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this medicine 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, urinary tract, etc.): The usual dose is 400 mg of this medicine once on the first day, followed by 200 mg once daily starting the next day; the dose may be increased to 400 mg once daily depending on 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 of this medicine once on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 5. 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. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine 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 with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. In such patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 7. For onychomycosis, administer 150 mg once weekly 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 approximately 6-12 months; the growth rate may vary from person to person and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine 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. ○ 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), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary when it is administered only once. However, when 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) > 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 Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on adult doses generally follow the criteria below and should not exceed 400 mg. 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 However, safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine 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. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. 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/kg body weight once daily. The treatment duration is determined based on clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine on the first day, followed by 6 mg/kg body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg body weight once daily. 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/kg body weight once daily after the patient has completed all initial treatment. 6. Children with renal impairment: Depending on the degree of renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment. When administering a dose below 10 mg, to ensure accurate dosing, administer the syrup orally or the injection intravenously according to the child's clinical condition.

This medication should not be administered to certain patients. For example, patients who have had an allergic reaction to this medication or similar drugs, pregnant women or women who may become pregnant, and breastfeeding women should not use this medication. Additionally, since serious side effects may occur when taken with certain drugs, it is essential to consult with a doctor. This medication contains lactose and should not be given to patients with lactose intolerance or related genetic disorders. This medication must be used with caution in patients with kidney or liver issues, heart conditions, or electrolyte imbalances. Furthermore, this medication can interact with other drugs by inhibiting certain enzymes, thus patients taking multiple medications require close monitoring by healthcare personnel. Generally, this medication has fewer side effects, but rarely may cause blood abnormalities, allergic reactions, liver dysfunction, cardiac arrhythmias, and gastrointestinal disorders. Regular liver function tests during treatment are important, as liver function may deteriorate. During pregnancy, this medication may be harmful to the fetus, therefore usage should be avoided, and women of childbearing age should practice effective contraception during and for a period after taking the medication. Breastfeeding women should also refrain from taking this medication. In children under 6 months of age, safety and efficacy have not been established, so it should be administered cautiously only when absolutely necessary. When taking this medication, it is important to be cautious of dizziness or seizures while driving or operating machinery. In case of overdose, hallucinations or unusual behaviors may occur, prompting immediate medical attention. This medication is primarily excreted in urine, so increasing urine output or hemodialysis may help in case of overdose.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesteremia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste distortion, tremors, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, elevated ALT, elevated AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular injury, 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly closed container to protect it from air or moisture. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

It is a hard capsule with a sky blue upper part and a white lower part containing a white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle