Diconazole Capsule 50mg (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 orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral discomfort due to dentures): The usual dose is 50 mg 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 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 once on the first day, followed by 200 mg once daily from the next day; based on the patient's response, the dose may be increased to 400 mg once daily. The duration of treatment should be determined according to clinical response and medical judgment. 4. 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 the 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, after the patient has completed initial therapy, administer 200 mg once daily indefinitely. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg once daily, depending on the patient's risk of fungal infection. 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, 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 higher. 7. 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 6-12 months; the rate of growth may vary between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. 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 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 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 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, and adjust the dose from the next day as follows. Creatinine clearance (mL/min) > 50: 100 % of the usual dose ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session For patients receiving hemodialysis, 100% of the usual dose should be administered after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced 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, the safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg 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 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, followed by 6 mg/kg once daily from the next day. Depending on the patient's response, the dose may be increased to 12 mg/kg 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 once daily after the patient has completed initial treatment. 6. For children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering a dose below 10 mg, administer the appropriate amount orally as syrup according to the child's clinical condition, or administer it intravenously by injection.

This drug should not be used in certain patients. Firstly, patients who have had allergic reactions to this drug or similar medications should not take it. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication. Additionally, serious side effects may occur if taken with certain drugs, thus co-administration is prohibited. This drug contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. Patients with kidney or liver dysfunction, heart diseases, or electrolyte imbalances who are at risk of arrhythmias should use this drug cautiously. Furthermore, patients with a history of drug allergies should also exercise caution. This drug may affect liver and kidney function, hence, patients with impaired function should be carefully evaluated before administration. While this drug is generally safe, rare side effects such as blood disorders, allergic reactions, liver dysfunction, cardiac rhythm abnormalities, gastrointestinal disturbances, and skin rashes may occur. Particularly, liver dysfunction may worsen, so it is important to undergo regular liver function tests during treatment. This drug has numerous interactions with other medications, so caution is advised when co-administered with drugs that affect cardiac rhythm or specific antibiotics, anticoagulants, antidepressants, and immunosuppressants. Additionally, this drug may increase the blood concentration of some medications, elevating the risk of side effects; therefore, it is crucial to inform the healthcare provider about other medications being taken. During pregnancy, this medication may harm the fetus, hence, women of childbearing age should employ contraception during the treatment period and for a certain period after. Breastfeeding women should avoid this medication as it is secreted into breast milk. There is limited safety data for infants and children, so it should only be administered cautiously when necessary. During the intake of this medication, dizziness or seizures may occasionally occur, hence caution is advised while driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, thus immediate medical attention should be sought, and appropriate treatment such as gastric lavage may be required. This medication is primarily excreted unchanged in the urine, so increasing fluid intake may enhance clearance, and some can be removed through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, tremors, vertigo, Torsades de Pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocyte necrosis, hepatitis, hepatocellular injury, rash, pruritus, urticaria, increased sweating, drug eruption, 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, paranoid behavior

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1°C and 30°C. This way, the efficacy of the medication can be maintained for a longer period.

Appearance

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

Package unit

30 capsules/bottle