DIFLUZOL Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. As oral formulations are absorbed rapidly and almost completely, 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 of this medicine is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral discomfort due to dentures): The usual dose of this medicine is 50 mg once daily for 14 days; local disinfection of the dentures should also be performed. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this medicine 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 of this medicine 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 administration should be determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine 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 of this medicine once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, according to the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg beginning 5-6 days before neutropenia is expected to develop, 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 until the fingernails or toenails have regrown (until uninfected new nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rate may vary by individual and age. In some cases, the nails may remain damaged after successful treatment with long-term administration. For cutaneous fungal infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose of this medicine 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 clinical course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. In patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary when administered as a single dose. 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 > 50 mL/min: 100% of the usual dose Creatinine clearance ≤50 mL/min (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. The safety and efficacy of this medicine have not been established in infants younger than 6 months (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine 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. Administer 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.): Administer 6-12 mg/kg body weight once daily. The duration of administration should be determined according to clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine 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. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg body weight once daily after the patient has completed primary treatment. Pediatric patients with renal impairment should have the dosing interval extended and the dose reduced according to the same criteria as for adults with renal impairment, depending on the degree of renal impairment. When administering a dose of less than 10 mg, administer 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. Patients allergic to this medication or similar drugs, as well as pregnant or breastfeeding women, should not take this medication. Additionally, patients with specific heart diseases or those taking other medications that interact severely with this drug should avoid its use. This medication contains lactose and is unsuitable for patients with genetic issues such as lactose intolerance. Caution is advised when using this medication in patients with renal or liver dysfunction, heart diseases, or those at risk for arrhythmias. Regular liver function tests are necessary as this medication can affect liver function. Moreover, it inhibits certain enzymes, which can raise the concentrations of other medications, so consult a doctor or pharmacist about other medicines being taken. Patients may experience gastrointestinal symptoms such as headaches, abdominal pain, diarrhea, and vomiting during treatment, and rarely may suffer from severe side effects such as liver damage or cardiac arrhythmias. Skin rashes or allergic reactions should be immediately reported to healthcare professionals. Women who are pregnant or could become pregnant should use effective contraception while taking this medication, especially during the first three months of pregnancy, as its use can be particularly risky. Breastfeeding women should avoid taking this medication as it can be passed into breast milk. For children under 6 months of age, safety has not been established, and it should be used cautiously only if necessary. This medication can sometimes cause dizziness or seizures, so careful attention is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors may occur, and appropriate medical treatment should be sought immediately. This medication is primarily excreted in urine, hence increasing fluid intake is advised, and it can be removed via hemodialysis if necessary.

Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia, Anaphylaxis, Angioedema, Hypertriglyceridemia, Hypercholesterolemia, Hypokalemia, Insomnia, Drowsiness, Headache, Seizure, Dizziness, Paresthesia, Dysgeusia, Tremor, Vertigo, Torsades de Pointes, QT Prolongation, Abdominal Pain, Diarrhea, Nausea, Vomiting, Dyspepsia, Bloating, Dry Mouth, Increased ALT, Increased AST, Increased Blood Alkaline Phosphatase, Cholestasis, Jaundice, Increased Bilirubin, Hepatotoxicity, Liver Failure, Hepatocyte 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, Paranoid Behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to keep the medication at room temperature, ideally between 1 to 30 degrees Celsius, avoiding extreme temperatures.

Appearance

Hard capsule with blue upper part and white lower part containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle