Dinazol 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. ○ Adults 1. Vaginal candidiasis: Administer fluconazole 150 mg orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg of this drug once daily for 14 days, together with local disinfection of the dentures. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this drug 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, genitourinary, etc.): The usual dose is 400 mg of this drug once 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 should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug 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 be continued for at least 6 ~ 8 weeks. 5. To prevent relapse 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 risk of developing a fungal infection. 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 onset of neutropenia is expected and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; the rate of growth may vary between individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Skin fungal infections, including tinea pedis, tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg of this drug once daily or 150 mg once weekly for 2-4 weeks. However, treatment of tinea pedis 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. ○ Older adults If renal function is normal, the usual adult dose may 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 for a single dose; however, when multiple doses are required, administer the usual dose on the first day only 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 a maximum of 400 mg. Safety and efficacy have not been established in infants younger than 6 months (see Precautions). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, then 3 mg/kg once daily from the following day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of this medicine on the first day, then 3 mg/kg once daily from the following day. The dose may be increased 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. 3. 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 clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of this medicine on the first day, then 6 mg/kg once daily from the following 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. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all initial treatment. 6. In children 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, according to the child's clinical condition, to ensure an accurate dose.

This medication should not be administered to certain patients. For example, it should not be used in individuals who are allergic to this drug or similar medications, pregnant or breastfeeding women, and patients with specific heart conditions or those taking certain medications. Additionally, patients with genetic problems such as lactose intolerance should not take this medication. Patients with kidney or liver dysfunction or heart disease should exercise caution when using this drug, and it should be administered carefully in cases of drug hypersensitivity. This medication may worsen liver function, making it essential to undergo regular liver function tests. Since it may cause arrhythmias, patients should undergo cardiac assessments while on treatment. This drug can interact with various medications, so it is crucial to inform the doctor or pharmacist of any concurrent medications being taken. Pregnant or potentially pregnant women should ensure effective contraception during and for a period after taking this drug, and it should be avoided during early pregnancy. Breastfeeding women are advised to avoid using this medication as it may be transmitted through breast milk. Safety in infants less than 6 months old has not been sufficiently established; therefore, it should be used only if necessary. This medication can cause dizziness or seizures, so caution is needed when driving or operating machinery. In the event of an overdose, hallucinations or abnormal behavior may occur, necessitating immediate contact with a medical facility and possible gastric lavage or supportive therapy. This drug is primarily excreted through urine, and overdose may be managed by lowering drug concentration through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disorder, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, increased ALT, increased AST, increased blood 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, asthenia, fever, adrenal insufficiency, hallucinations, paranoid behavior

Store this medication in a tightly sealed container to prevent air and moisture exposure, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the medication's efficacy.

Appearance

Capsules with a light blue upper part and a white lower part containing a white to off-white powder

Package unit

Bottle - 100 capsules/bottle, Bottle - 30 capsules/bottle