Apogen Fluconazole Capsule

Adult dosage

The route of administration is 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 150 mg of fluconazole orally as a single dose. Oropharyngeal candidiasis: The usual dose is 50 mg of this medication 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 is 50 mg of this medication once daily for 14 days, and local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this medication 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 is 400 mg of this medication as a single dose on the first day, followed by 200 mg once daily starting the next day. The dose may be increased to up 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 of this medication as a single dose 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 usually continue for at least 6 ~ 8 weeks. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed the full course of primary treatment, administer 200 mg of this medication once daily indefinitely. 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 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 infection, such as those undergoing bone marrow transplantation, or patients expected to have severe or prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before neutropenia is expected to begin, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. Onychomycosis: Administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected fingernails or toenails have grown). New fingernails usually take 3-6 months to grow, and toenails take 6-12 months; the rate of growth may vary by individual and age. In some cases, the fingernails or toenails may remain damaged even 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 is 50 mg of this medication once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks, depending on the clinical course. 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 medication is excreted mainly in the urine in unchanged form. No dose adjustment is necessary when administering a single dose; however, when multiple doses are required, administer the usual dose only on the first day, then adjust the dose as follows starting the next day. 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 Pediatric doses based on adult doses are generally determined according to the following criteria and should not exceed 400 mg. Safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of this medication on the first day, followed by 3 mg/kg once daily starting the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medication on the first day, followed by 3 mg/kg once daily starting the next day. The dose may be increased to up to 12 mg/kg 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.): Administer 6-12 mg/kg once daily. The duration of treatment is determined according to the clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medication on the first day, followed by 6 mg/kg once daily starting the next day. The dose may be increased to 12 mg/kg 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: After the patient has completed the full course of primary treatment, administer 6 mg/kg once daily. Pediatric patients with renal impairment: Depending on the degree of renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering a dose of less than 10 mg, administer the oral syrup or inject the injectable formulation intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be administered to certain patients. For instance, individuals who are allergic to this medication or similar drugs, pregnant women, or nursing mothers should not take it. Additionally, it should be avoided when taken with certain medications as serious side effects can occur. For example, taking it with heart-affecting medications or certain antibiotics and antihistamines can be dangerous. Since this medication contains lactose, patients with lactose intolerance or related genetic diseases should not take it. Caution is needed for patients with kidney or liver function problems. Regular monitoring is required as liver function may worsen. Patients with heart diseases or electrolyte imbalances should also exercise caution as arrhythmias or other heart abnormalities may develop. It is safe to administer this medication under regular monitoring of liver and kidney function, and blood status. This medication is generally well tolerated, but in rare cases, severe allergic reactions, liver damage, and blood abnormalities can occur. During pregnancy, especially in early stages, taking this medication can harm the fetus, so it should be avoided, and effective contraception should be used during treatment. Nursing mothers should also avoid taking this medication as it can be passed through breast milk. It has not been established as safe in young children, especially in infants under 6 months old, and should only be used cautiously when necessary. Caution is needed when driving or operating machinery due to possible dizziness or seizures during treatment. In case of overdose, hallucinations or unusual behavior may occur, and immediate medical assistance should be sought, which may include gastric lavage or dialysis. Lastly, this medication interacts with many other drugs, so it is essential to inform healthcare providers about any other medications being taken and to monitor for interactions.

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, elevated 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 reactions with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

A hard capsule with a blue upper part and a white lower part containing a white to off-white powder.

Package unit

30, 100 capsules/bottle