Ronal Capsule 50 Milligrams (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. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 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 soreness caused by 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 infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal 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; the dose may be increased to up to 400 mg once daily according to the patient's response. The duration of treatment should be determined based on 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 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, depending on the patient's risk of developing a 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 starting 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 more. For onychomycosis of the fingernails or toenails, administer 150 mg once a week until the nails have regrown (until new, uninfected nails have grown). It generally takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; the growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine once daily or 150 mg once a week 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 extended. Patients with renal impairment: This medicine is excreted mainly in the urine unchanged. No dose adjustment is required for a single dose, but when multiple doses are required, administer the usual dose only on the first day and adjust the dose from the following day as described below. 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

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 of this medicine in infants younger than 6 months have not been established (see Precautions for Use). 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. The dose may be increased to up to 12 mg/kg once daily according to the patient's response. Treatment should continue 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 once daily. The duration of treatment should be determined based on 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. The dose may be increased to 12 mg/kg once daily according to the patient's response. 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 primary treatment. In pediatric patients 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. When administering a dose of less than 10 mg, administer the syrup orally or inject the injectable formulation intravenously according to the child's clinical condition to ensure accurate dosing.

This drug should not be used in certain patients. For example, patients with allergies to this drug or similar medications, women who are pregnant or lactating, and patients taking certain specific medications should not be administered this drug. Moreover, caution should be exercised when prescribing this drug to patients with poor kidney or liver function, those with heart disease or at risk for arrhythmias, and patients with a history of drug allergies. Generally, this drug has few side effects, but in rare cases, adverse reactions such as blood disorders, liver dysfunction, skin rashes, gastrointestinal issues, and cardiac arrhythmias may occur. Therefore, if unusual symptoms arise during treatment, it is essential to consult healthcare professionals immediately. This drug can interact with various medications; hence, if you are taking other medicines, it is crucial to inform your doctor or pharmacist. Special care is needed when combined with drugs that can affect the heart, anticoagulants, antidepressants, and immunosuppressants. Women who are pregnant or planning to become pregnant should consult healthcare providers before taking this drug and ensure effective contraception during the treatment period and for a certain duration after treatment. Lactating women should consider stopping breastfeeding or discussing alternative treatments, as this drug may be transferred into breast milk. The safety of this drug has not been established for children, especially infants under 6 months of age; it should only be administered cautiously when absolutely necessary. Caution should be exercised when driving or operating machinery, as dizziness or seizures may occur while taking this medicine. In case of overdose, hallucinations or abnormal behavior may occur, and immediate assistance from healthcare professionals is required, including possible gastric lavage or supportive therapy. The dose and administration frequency of this medication need to be adjusted according to kidney function, and it is important to undergo regular blood tests and liver and kidney function tests before and during treatment.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbances, 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, liver failure, hepatocyte necrosis, hepatitis, hepatocellular 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 reactions accompanied by 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, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for a longer period.

Appearance

Hard capsule with a blue upper part and a white lower part

Package unit

30 capsules/bottle, 50 capsules/bottle