Tinazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vaginal candidiasis: Administer a single 150 mg oral dose of fluconazole. Oropharyngeal candidiasis: The usual dose 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 is 50 mg once daily for 14 days; 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 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 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 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 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 once daily indefinitely after the patient has completed all primary treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50–400 mg once daily according to the patient's risk of fungal infection. 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, 400 mg once daily is recommended. In these patients, administer 400 mg beginning 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. Continue treatment 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; growth rate may vary by age and individual. In some cases, fingernails or toenails may remain damaged after successful long-term treatment. For cutaneous fungal infections, including tinea pedis, tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2–4 weeks. However, tinea pedis may require treatment for 6 weeks, depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2–4 weeks. When 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 increased. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose; however, if multiple doses are required, administer the usual dose on the first day only 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, 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 a maximum of 400 mg. 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. 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. Treat 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 is 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 primary treatment. In pediatric patients with renal impairment, increase the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, it should not be administered to individuals who are allergic to this drug or similar components, or to pregnant or breastfeeding women. Furthermore, patients taking certain drugs that have severe interactions with this medication should also avoid its use. For instance, taking this medication with drugs that may affect the heart can be dangerous. Patients with lactose intolerance or specific genetic metabolic disorders should not take this drug. When using this medication, it should be administered cautiously to patients with impaired kidney or liver function, patients with heart diseases or patients who are at risk of arrhythmias due to electrolyte abnormalities. This drug can affect liver and kidney functions, so it is advisable to conduct blood tests and tests for liver and kidney function before treatment. In addition, because this drug can affect cardiac electrical signals, caution is warranted for patients with heart diseases or those who are taking certain medications. During the use of this drug, side effects such as headaches, abdominal pain, diarrhea, liver function abnormalities, skin rashes, etc. may occur, and any abnormal symptoms should be reported to a healthcare professional. Pregnant women or women who could become pregnant should take precautions to avoid potential harm to the fetus while using this medication, and it should be avoided during pregnancy. Breastfeeding women should also avoid taking this medication as it can be excreted in breast milk and affect the baby. The safety of this medication in children, especially infants under 6 months old, has not yet been established, so it should only be used cautiously when absolutely necessary. This drug may occasionally cause dizziness or seizures, so caution is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors may occur, requiring immediate visit to a healthcare institution for appropriate treatment. Finally, this medication can interact with various other drugs, so if you are taking other medications, be sure to inform your healthcare professional, and dose adjustments or monitoring may be required if necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, 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, hepatic failure, hepatocyte necrosis, hepatitis, hepatocellular damage, rash, pruritus, 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, lassitude, weakness, fever, adrenal insufficiency, hallucinations, agitated behavior

This medication should be stored in a tightly closed container that prevents air from entering and at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its effectiveness and safety.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle