Sincornazole Capsule (Fluconazole)

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. 1. Vulvovaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose 2. Mucosal candidiasis 1) 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. 2) Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose of this drug is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., 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. 3. 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 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 according to the patient's response. The duration of treatment should be determined based on clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed by 200-400 mg once daily starting the next day. The duration of treatment is determined by clinical and mycological response, but treatment should generally be continued for at least 6 ~ 8 weeks. 5. 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. 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 drug once daily, depending on the patient's level of risk for fungal infections. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those undergoing bone marrow transplantation, who have severe neutropenia or are expected to have prolonged neutropenia. In these 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 fingernail or toenail has regrown (until an uninfected new fingernail or toenail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary among individuals and by 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 of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks depending on its course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. Elderly patients: If renal function is normal, the usual adult dose should be 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 drug is excreted primarily unchanged in the urine. No dose adjustment is necessary when administering a single dose. If multiple doses are required, administer the usual dose on the first day only, then 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

Pediatric doses based on adult doses are generally determined according to the following guidelines 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, the safety and efficacy of this medicine in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of body weight of this medicine on the first day, followed by 3 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of 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 (e.g., peritoneal, endocardial, pulmonary, and urinary tract infections): Administer 6-12 mg/kg of body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of body weight of this medicine on the first day, followed by 6 mg/kg of body weight once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg of 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 of body weight once daily after the patient has completed primary treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the degree of renal impairment, using the same criteria as for adults with renal impairment. When administering a dose below 10 mg, give the syrup orally or the injection intravenously, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, it is not safe for women who are pregnant or breastfeeding, or for patients with allergies to this drug or similar drugs. Patients taking certain medications should exercise caution when using this drug. Moreover, patients with poor kidney or liver function, or those with heart disease or a history of drug allergies should be particularly careful when using this drug. In such cases, it is important to consult a doctor for appropriate dose adjustments or monitoring. This drug can affect liver and kidney functions, so it is recommended to have blood tests and tests for liver and kidney functions carried out before treatment. Regular monitoring of these tests is also necessary during treatment. While taking this drug, rare side effects such as skin rash, liver dysfunction, blood abnormalities, or cardiac arrhythmias may occur, so if any abnormal symptoms arise, you should immediately inform your healthcare provider. This drug has many interactions with other medications, so you must inform your healthcare provider if you are currently taking other medications and observe carefully. Special caution is required when combined with drugs that affect the heart or are metabolized in the liver. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication and should use effective contraceptive methods during and for a certain time period after taking this medication. It is not recommended for nursing mothers to take this medication. If it must be taken, it should be done under the guidance of a healthcare professional. The safety and efficacy of this medication in children, especially infants under 6 months of age, have not been established, so it should only be used when necessary and under professional judgment. Caution is required when driving or operating machinery, as this medication may cause dizziness or seizures. Finally, in case of overdose, hallucinations or unusual behavior might occur, so it is crucial to adhere to the prescribed dosage, and in the case of overdose, you should promptly visit a medical institution for appropriate treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, ALT increase, AST increase, blood alkaline phosphatase increase, cholestasis, jaundice, bilirubin increase, hepatotoxicity, hepatic 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, adrenal insufficiency, hallucinations, psychotic behavior

Store this medication in a tightly closed container that is air-tight, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the efficacy of the drug for a longer time.

Appearance

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

Package unit

30 capsules/bottle