Pronan Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Absorption of the oral formulation is rapid and nearly complete; therefore, the doses of the oral formulations (capsules, dry syrup) and injectable formulation are the same. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. Oropharyngeal candidiasis: The usual dose of this drug is 50 mg once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose of this drug is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose of this drug 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 drug is 400 mg as a single dose 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 is determined according to clinical response and medical judgment. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg as a single dose 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 usually continue for at least 6 ~ 8 weeks. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: After the patient has completed all initial treatment, administer 200 mg of this drug once daily indefinitely. 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 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 infections, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in bone marrow transplantation. 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, 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 about 6-12 months; growth rates may vary by individual and age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For dermatophyte infections of the skin, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this drug 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 the course. Tinea versicolor: Administer 50 mg once daily for 2-4 weeks. Older adults: If renal function is normal, administer the usual adult dose. If renal impairment is present (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. Patients with renal impairment: No dose adjustment is needed when a single dose is administered; however, when 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 > 50 mL/min: 100 % of the usual dose Creatinine clearance ≤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 non-dialysis days, 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. Infants younger than 6 months: Safety and efficacy have not been established. Oropharyngeal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. Treatment should be continued for at least 2 weeks to prevent recurrence. Esophageal candidiasis: 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/kg of 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.): 6-12 mg/kg of body weight once daily. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis: 12 mg/kg of body weight on the first day, then 6 mg/kg of body weight once daily from the following day. The dose may be increased to 12 mg/kg of body weight once daily according to the patient's response. Treatment should be continued for 10-12 weeks after cerebrospinal fluid cultures become negative. Prevention of recurrence of cryptococcal meningitis in patients with AIDS: 6 mg/kg of body weight once daily after the patient has completed all initial treatment. Pediatric patients with renal impairment: Depending on the degree of renal impairment, extend the dosing interval and reduce the dose according to the same criteria used for adults with renal impairment. When administering doses below 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 administered to specific patients. For example, patients allergic to this medication or other azole drugs, pregnant women, women who may become pregnant, and breastfeeding women should not use this medication. Additionally, patients taking certain medications that can cause severe side effects should avoid using this medication. For example, concurrent use with terfenadine, cisapride, astemizole, or erythromycin can cause heart problems. Patients with lactose intolerance or those who cannot metabolize lactose genetically should also refrain from taking this medication. There are also patients who require caution during administration. Individuals with a history of drug allergies, patients with kidney or liver problems, and those at risk of arrhythmia due to heart disease or electrolyte imbalances should be careful when using this medication. This medication can affect liver and kidney function, so blood tests and liver and kidney function tests are recommended before administration. It can also affect cardiac electrical activity; thus, patients with heart disease should closely monitor their heart condition while taking this medication. This medication can interact with various drugs, so patients taking other medications should definitely consult with healthcare professionals. Taking it with some other medications may increase blood drug concentrations or the risk of side effects. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should practice effective contraception for one month during and after the course of this medication. The safety of this medication has not been established in children, especially infants under 6 months of age, and it should only be used when necessary. Dizziness or seizures may occur while taking this medication, so caution is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors may occur, so immediate medical attention should be sought, and detoxification and supportive care may be necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizure, dizziness, paresthesia, taste disturbance, tremor, 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, hepatocyte 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, malaise, asthenia, fever, adrenal insufficiency, hallucinations, psychotic behavior

This medication should be stored in a sealed container that prevents air exposure and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance

Hard capsules with a blue top and white bottom containing white powder

Package unit

30 capsules/bottle