Conizole Capsule 50 mg (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 150 mg of fluconazole as a single oral 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 due to dentures): The usual dose is 50 mg of this drug 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 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, urinary tract, 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; the dose may be increased to 400 mg once daily depending on the patient's response. 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 given 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 primary 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 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 beginning 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 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 approximately 6-12 months; growth rates may vary from person to person and with age. In some cases, the nails may remain damaged even after successful treatment with long-term administration. For cutaneous fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (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, 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. ○ Older adults 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 should be extended. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. 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 of treatment, 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 on 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

○ Children 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, safety and efficacy have not been established in infants younger than 6 months (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer this drug at 6 mg/kg body weight on the first day, then 3 mg/kg body weight once daily from the following day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer this drug at 6 mg/kg body weight on the first day, then 3 mg/kg body weight once daily from the following day. Depending on the patient's response, the dose may be increased to 12 mg/kg 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 (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg body weight once daily. The duration of administration should be determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer this drug at 12 mg/kg body weight on the first day, then 6 mg/kg body weight once daily from the following day. Depending on the patient's response, the dose may be increased to 12 mg/kg 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 body weight once daily after the patient has completed all initial treatment. 6. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the degree of renal impairment, using the same criteria as 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 an accurate dose.

This drug should not be used in certain patients. First, people who are allergic to this drug or have had hypersensitivity reactions to similar components should not take it. Furthermore, pregnant women, women who might become pregnant, and nursing mothers should not use this drug. Serious side effects may occur when taken with certain medications, so patients on such medications should avoid using this drug. This drug contains lactose and is not administered to patients with genetic metabolic disorders like lactose intolerance. Caution is required when using this drug in patients with poor kidney or liver function, heart diseases, or at high risk of arrhythmias. Patients with a history of drug allergies also need to be careful. This drug inhibits the action of several enzymes metabolizing in the liver, so when taken with other medications, monitoring by a physician is necessary as drug concentrations may change. Generally, this drug is considered safe, but rarely, it can cause adverse reactions related to blood, liver, kidney, skin rashes, digestive disorders, headache, dizziness, etc. Especially, liver function may worsen, so regular liver function tests should be conducted during treatment. Taking this drug during pregnancy, especially in early pregnancy, may harm the fetus; therefore, women who are pregnant or planning to become pregnant must consult a doctor. During breastfeeding, as this drug is secreted into breast milk, it is best to avoid nursing. Many drugs should not be taken with this drug, so it is crucial to inform healthcare providers of any current medications. Particular attention should be paid to interactions with drugs affecting the heart, anticoagulants, certain antibiotics, anticonvulsants, and immunosuppressants. Dizziness or seizures may occur during driving or machine operation, so caution is required. In case of overdose, hallucinations or unusual behavior may occur, and medical attention should be sought immediately, with treatment provided as per the symptoms. This drug is primarily excreted through urine, so increasing fluid intake to promote excretion is helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, lightheadedness, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocyte 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, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This drug should be stored in a sealed container that is airtight, and the recommended storage temperature is between 1°C and 30°C at room temperature. Proper storage helps maintain the drug's effectiveness and prevents degradation.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle