Pulconazole Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient’s clinical condition. Oral formulations are rapidly and almost completely absorbed; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg once daily for 7-14 days; treatment may be extended at the physician’s discretion. 2) Chronic atrophic oral candidiasis (oral soreness caused by dentures): The usual dose is 50 mg once daily for 14 days, and local disinfection of the dentures should be performed concurrently. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg once on the first day, followed by 200 mg once daily starting 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. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg once on the first day, followed by 200-400 mg once daily starting 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. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg once daily, depending on the patient’s level of 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, or those expected to have severe neutropenia or prolonged neutropenia. In such patients, 400 mg should be administered starting 5-6 days before the onset of neutropenia is expected and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). Regrowth of a new fingernail usually takes 3-6 months and of a toenail 6-12 months; growth rates may vary between individuals and with age. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. For cutaneous fungal infections, including athlete’s foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose 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 of the infection. For pityriasis versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose should be 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 mainly in the urine unchanged. No dose 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 following day as follows: Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not receiving 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, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on the adult dose 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, safety and efficacy have not been established in infants under 6 months of age (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer this medicine at 6 mg/kg of body weight on the first day, then 3 mg/kg of body weight once daily from the following day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer this medicine at 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 depending on the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg of body weight once daily. The treatment period is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer this medicine at 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 depending on the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg of body weight once daily after the patient has completed all initial treatment. 6. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the same criteria used for adults with renal impairment, based on the degree of renal impairment. When administering doses under 10 mg, oral syrup or intravenous injection should be used, depending on the child's clinical condition, to ensure accurate dosing.

This medication should not be used in certain patients. For example, it should not be administered to individuals who have had an allergic reaction to this drug or similar drugs, pregnant or breastfeeding women, and patients with certain heart conditions or who are taking specific medications. Furthermore, patients with genetic metabolic disorders such as lactose intolerance should also avoid taking this medication. Caution is necessary when using this medication. Individuals with a history of drug allergies, those with kidney or liver function issues, and patients with heart disease or electrolyte imbalances should use this medication carefully. Since this medication can affect liver function, it is essential to have regular liver function tests. Additionally, it can affect heart electrical activity, posing a risk of arrhythmias, so patients with heart disease should exercise particular caution. This medication can interact with several other medications, so if there are other medications being taken, it is important to consult with a healthcare provider. Serious side effects can occur with concomitant use of some drugs, so co-administration should be avoided, or dosage adjustments may be necessary. During pregnancy, this medication may harm the fetus, so it is best to avoid its use, and women of childbearing age should use effective birth control during and for some time after taking this medication. Breastfeeding women should also avoid this medication, as it can be transmitted through breast milk and may affect the baby. The safety of this medication in young children, especially infants under 6 months of age, has not been established, so it should only be administered cautiously when necessary. During treatment, caution should be taken while driving or operating hazardous machinery, as dizziness or seizures may occur. Finally, overdose of this medication may result in hallucinations or abnormal behavior, and immediate medical assistance should be sought. Treatment for overdose may include symptomatic treatment, and if necessary, assistance in removing the drug via dialysis.

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, hepatic failure, hepatocellular 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 with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, aggressive behavior

This medication can be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage can help maintain the medication's effectiveness for a longer period.

Appearance

A hard capsule with a sky blue upper part and a white lower part filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle