Joafluconazole Capsule 50mg

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. Vulvovaginal candidiasis: Administer a single oral dose of 150 mg fluconazole. Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral pain due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal 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. 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 is determined according to the clinical response and medical judgment. 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 the clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 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. 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 medicine 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 those undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the onset of neutropenia is expected and continue 400 mg for 1 week after the neutrophil count increases to 1,000 cells/mm3 or higher. For onychomycosis, administer 150 mg once weekly until the fingernail or toenail has regrown (until an uninfected new nail has grown). Regrowth of a new fingernail usually takes 3-6 months and a toenail 6-12 months; the growth rate may vary by individual and age. Even after successful treatment with long-term administration, nails 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 pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, the usual adult dose is generally 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 mainly in the urine unchanged. 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 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 of this medicine in infants younger than 6 months have not been established. Oropharyngeal candidiasis: 6 mg/kg body weight on the first day, followed by 3 mg/kg body weight once daily from the next day. Treatment should continue 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, and urinary tract infections, etc.): 6-12 mg/kg body weight once daily. The duration of treatment is determined according to the 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. Treatment should continue 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 primary treatment. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses of less than 10 mg, give the syrup orally or administer the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This drug should not be administered to certain patients. For example, patients who have had allergic reactions to this drug or similar components, pregnant women or those with the possibility of pregnancy, and nursing mothers should not take this medication. Additionally, patients who are taking certain other medications should not take this drug concurrently. Serious side effects may occur when combined with drugs that affect heart rhythm or certain antibiotics and antihistamines. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid it. Patients with a history of drug hypersensitivity, impaired kidney or liver function, heart disease, or electrolyte imbalances should be particularly cautious when taking this medication. This medication can inhibit certain enzymes, leading to increased blood concentrations of other drugs, so patients taking multiple medications will require careful monitoring and dosage adjustments by healthcare professionals. Reported side effects of this medication include headache, dyspepsia, abnormal liver function, skin rashes, and hematological abnormalities, with rare cases of severe liver damage or cardiac arrhythmias. It is advisable not to use this drug during pregnancy, especially in the early stages, due to an increased risk of miscarriage or congenital malformations, and contraception is recommended. Nursing mothers should also avoid this medication, as it is excreted in breast milk. The safety and efficacy in children, particularly infants under 6 months of age, have not been adequately established, so caution is advised. During treatment with this drug, dizziness or seizures may occur when driving or operating machinery, so caution is advised. In case of overdose, hallucinations or unusual behavior may occur, and immediate medical attention should be sought for appropriate treatment. This drug is primarily excreted through urine, so in cases of overdose, drug removal through hemodialysis is possible but requires management by healthcare professionals.

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, ALT increase, AST increase, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular 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, hallucinations, paranoid behavior

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture, and it is important to maintain a storage temperature between 1 to 30 degrees Celsius. Therefore, store it in a cool and dry place away from direct sunlight and high temperatures until it is used.

Appearance

A hard capsule with a blue top and white bottom, containing a white to yellowish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle