Pughazol Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injections are the same. 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single 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 due to 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 infection, 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 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 should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 the clinical and mycological response, but treatment should usually be continued for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infection 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 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 bone marrow transplant recipients with severe neutropenia or in whom a prolonged period of neutropenia is expected. In these patients, administer 400 mg starting 5-6 days before the onset of neutropenia is expected and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7. For onychomycosis, administer 150 mg once weekly; continue treatment 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 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. Dermal 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 condition. 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 mainly in the urine in unchanged form. Dose adjustment is not required for a single dose; however, 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 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 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

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 The safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg body weight of this medicine on the first day, followed by 3 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg 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 body weight once daily. The duration of treatment is determined according to clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg body weight of this medicine on the first day, followed by 6 mg/kg body weight once daily from the next day. The dose may be increased to 12 mg/kg 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 body weight once daily after the patient has completed the full course of initial treatment. 6. In pediatric patients with renal impairment, extend the dosing interval and reduce the dose according to the same guidelines used for adults with renal impairment, based on the degree of renal impairment. When administering doses of less than 10 mg, give the syrup orally according to the child's clinical condition or administer the injection intravenously to ensure accurate dosing.

This medication should not be administered to certain patients. For example, it should not be used in individuals with allergies to this medication or similar drugs, pregnant or breastfeeding women, and patients taking certain medications. Moreover, it should not be administered to patients with genetically determined lactose intolerance. When using this medication, it should be used with caution in patients with a history of allergy or those with impaired kidney or liver function, as well as in patients with heart diseases or electrolyte imbalances. This drug can cause side effects related to heart rhythm, so patients with heart conditions should be especially cautious. This medication can interact with other drugs, so patients taking other medications should definitely consult with their doctor or pharmacist. This medication can affect liver and kidney functions, thus it is advisable to undergo relevant tests before and during treatment. Pregnant women or women with a possibility of pregnancy should use effective contraception while taking this medication, and breastfeeding women should not take this medication. The safety of this medication in infants has not been fully established; it should only be used when absolutely necessary. Care is needed when taking this medication as dizziness or seizures may occur while driving or operating machinery. In case of overdose, hallucinations or abnormal behavior may occur, so immediate medical attention is required, and gastric lavage or supportive therapy may be administered if necessary. This medication is primarily excreted in urine, so in the case of overdose, increasing urine output may help, and it can be partially removed by hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbances, taste disturbances, 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, hepatic toxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication must be stored in a tightly sealed container to protect it from air or moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius.

Appearance

Hard capsules with green-blue upper part and white lower part containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle