Osconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because absorption of oral formulations is rapid and nearly complete, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: Administer a single oral dose of fluconazole 150 mg. Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine 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 is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose is 50 mg of this medicine 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 is 400 mg of this medicine 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 clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine 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 all primary treatment. Prevention of fungal infections in immunocompromised patients at risk 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 those undergoing bone marrow transplantation who are expected to have severe or prolonged neutropenia. 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 more. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the nails regrow (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails 6-12 months; growth rate may vary by age and between individuals. In some cases, the nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris, and cutaneous candidiasis: The usual dose is 50 mg of this medicine once daily or 150 mg once weekly for 2-4 weeks. However, tinea pedis may require treatment for 6 weeks, depending on the course of the infection. 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 unchanged in the urine. No dosage adjustment is necessary for 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 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 undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On nondialysis days, administer a reduced dose according to creatinine clearance.

Children's dosage

Adult dose 100 mg: pediatric dose 3 mg/kg, not to exceed a maximum of 400 mg. Adult dose 200 mg: pediatric dose 6 mg/kg, not to exceed a maximum of 400 mg. Adult dose 400 mg: pediatric dose 12 mg/kg, not to exceed a maximum of 400 mg. The safety and efficacy have not been established in infants younger than 6 months. Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. 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 have resolved. 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 should be determined according to clinical response and medical judgment. 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. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all primary treatment. 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. For doses of less than 10 mg, administer the oral syrup or intravenous injection, according to the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, individuals who are allergic to this drug or similar medications, pregnant or breastfeeding women, and patients taking certain heart medications should avoid taking this medication. Additionally, those with genetic issues such as lactose intolerance should not use this drug. Patients with impaired kidney or liver function and those with heart diseases should exercise caution when using this medication. This medication can affect liver and kidney function, so it is advisable to conduct blood tests and liver and kidney function tests before administration. Furthermore, it may affect heart rhythms, so individuals with heart disease require close monitoring by a physician. This drug can interact with various other medications, so if you are currently taking any other medications, it is essential to inform your doctor or pharmacist. Caution is particularly needed when used in conjunction with heart medications, anticoagulants, antidepressants, immunosuppressants, and analgesics. Pregnant women or those who may become pregnant should avoid taking this medication, as it may harm the fetus, so effective contraception should be used or the drug should be avoided. Breastfeeding women are also advised not to take this medication. The safety of this medication has not been established for young children, particularly infants under 6 months of age, and it should only be used if necessary. Caution should be exercised when driving or operating machinery while taking this medication, as dizziness or seizures may occur. If this medication is overdosed, hallucinations or abnormal behaviors may develop, so immediate medical attention is necessary. This drug is primarily excreted in urine; therefore, adequate hydration and, if necessary, hemodialysis can be used to remove it.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsades 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, liver failure, hepatocyte necrosis, hepatitis, hepatic 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, psychotic behavior

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

Hard capsule with blue upper part and white lower part containing white to light yellow powder

Package unit

30 capsules/bottle, 100 capsules/bottle