Diflucol Capsule 150 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 (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg as fluconazole. 2. 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 from 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 according to clinical response and medical judgment. 3. 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 from the next day. The duration of treatment depends on the clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this drug 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 starting 5-6 days before the anticipated onset of neutropenia, and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 6. 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; growth rates may vary by individual and age. Occasionally, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris (jock itch), and cutaneous candidiasis: The usual dose of this drug 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 course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients 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 extended. ○ Patients with renal impairment This drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose. If 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 ≤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.

This medication may not be suitable for certain patients. First, patients who have had allergic reactions to this drug or similar drugs, women who are pregnant or may become pregnant, and women who are breastfeeding should not use this medication. Moreover, patients taking certain medications concurrently are advised to avoid this drug, as serious adverse effects may occur. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. There are also patients who must use this medication cautiously, such as those with a history of drug allergy or those with kidney or liver dysfunction, or those at risk of arrhythmias due to heart disease or electrolyte imbalances. Furthermore, this drug inhibits enzymes involved in drug metabolism in the liver, which may lead to interactions with various medications, necessitating careful monitoring by a physician when used in combination. Generally, this drug has good tolerability; however, rare instances of blood or liver function abnormalities, skin rash, gastrointestinal symptoms, and neurological symptoms may occur. Particularly, liver function may deteriorate; therefore, regular liver function tests during treatment are important. Use of this medication during pregnancy may be harmful to the fetus; thus, women planning to conceive should use effective contraception for the duration of treatment and for one month after the last dose. Women who are breastfeeding should avoid breastfeeding, as this medication is excreted in breast milk. The safety data for infants and young children is limited, so it should only be used cautiously when absolutely necessary. Neurological symptoms such as dizziness or seizures may occur with this medication, so caution is advised when driving or operating machinery. If this medication is overdosed, symptoms such as hallucinations or unusual behavior may occur, requiring immediate contact with a medical institution for appropriate treatment. This medication is excreted through the kidneys; thus, treatment may be necessary to ensure rapid excretion in case of overdose.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic 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, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication should be stored in a tightly sealed container to prevent air or moisture infiltration. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Following these guidelines will ensure the medication's effectiveness is preserved safely.

Appearance

A capsule filled with white powder; the upper part is dark blue and the lower part is light blue.

Package unit

Company packaging unit