Alphafluconazole Capsule

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since absorption of the oral formulations is rapid and nearly complete, the doses of the oral formulations (capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose of this drug is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose of this drug is 50 mg once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, and mucocutaneous candidiasis, excluding vulvovaginal candidiasis): The usual dose of this drug 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 drug is 400 mg as a single dose on the first day, followed by 200 mg once daily from the next day; depending on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg as a single dose 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 generally continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug 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 drug once daily, depending on 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, or those expected to have severe or prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia, and continue 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). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; the growth rate may vary among individuals according to age. After successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte skin infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue for 6 weeks depending on the course of the infection. For tinea 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 drug is excreted primarily unchanged in the urine. No dosage adjustment is required for a single dose. If multiple doses are required, administer the usual dose only on the first day 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 receiving 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

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 a maximum of 400 mg. However, the safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg per kg of body weight of this drug on the first day, followed by 3 mg per kg of body weight once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg per kg of body weight of this drug on the first day, followed by 3 mg per kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg per kg of body weight once daily. Treatment should continue 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 per kg of body weight once daily. The duration of treatment is determined by clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg per kg of body weight of this drug on the first day, followed by 6 mg per kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg per kg of body weight once daily. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. 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. In 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 of less than 10 mg, administer the syrup orally or inject the injectable formulation intravenously, according to the child's clinical condition, to ensure an accurate dose.

This drug should not be used in certain patients. It should not be taken by individuals allergic to this drug or other azole drugs, or by women who are pregnant or breastfeeding. Additionally, it should be avoided in combination with certain medications that may pose risks to the heart. This drug contains lactose, and individuals with genetic issues such as lactase deficiency or galactose intolerance should not take it. Patients with renal or liver function problems or heart disease should use this drug cautiously. Special attention is needed for patients at risk of arrhythmias. This drug should be used with regular checks of liver and kidney function, and blood tests, as adrenal insufficiency may occur during treatment. Some patients may experience side effects such as headache, abdominal pain, diarrhea, or rash, and serious liver damage or cardiac arrhythmias may occur rarely. This drug has many interactions with other medications, so if you are taking other drugs, you must consult your doctor or pharmacist, and dosage adjustments or monitoring may be necessary when used concurrently. Pregnant women should avoid using this drug due to the potential risk to the fetus, and women of childbearing age should use effective contraception during and for some time after taking the drug. Breastfeeding women are also advised against taking this drug as it can pass into breast milk. Safety has not been established for infants under 6 months, so it should be used cautiously only when necessary. Dizziness or seizures may occur while taking this drug, so caution is required when driving or operating machinery. In case of overdose, hallucinations or unusual behaviors may occur, so immediate consultation with medical personnel and appropriate treatment is necessary.

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, serum alkaline phosphatase increase, cholestasis, jaundice, bilirubin increase, 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

This drug may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the effectiveness of the drug for a long time.

Appearance

A hard capsule with a blue upper part and a white lower part containing white powder

Package unit

30 Capsules/Bottle, 100 Capsules/Bottle