Acnozol Capsule (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single 150 mg oral dose of fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dosage of this medicine is 400 mg once on the first day, followed by 200 mg once daily from the next day; the dose may be increased to 400 mg once daily depending on the patient's response. The duration of treatment should be determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dosage of this medicine is 400 mg 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 usually continue for at least 6 ~ 8 weeks. 4. 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 initial therapy. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on 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 with severe neutropenia or an expected prolonged period of neutropenia, as in bone marrow transplantation. In these patients, 400 mg should be administered starting 5-6 days before neutropenia is expected to begin, and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 6. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the nails have regrown (until new, uninfected nails have grown). Regrowth of a new fingernail usually takes 3-6 months, and a toenail usually takes 6-12 months; the growth rate may vary by individual and 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 dosage of this medicine is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment of athlete's foot may need to continue 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 dosage may 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 medicine is excreted mainly in the urine unchanged. Dose adjustment is not necessary when administering a single dose. If 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) / Recommended dose > 50 / 100 % of the usual dose ≤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 days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

This medication should not be used in certain patients. For example, individuals who have had allergic reactions to this medication or similar drugs may be at risk if administered. Additionally, women who are pregnant or potentially pregnant, and those who are breastfeeding should not take this medication, as it may harm the fetus or neonate. There may also be risks when taken in conjunction with specific medications, so if you are currently taking other medications, you should definitely consult your doctor or pharmacist. In particular, coadministration with drugs that affect the heart, specific antibiotics, or medications that affect heart rhythm should be avoided. This medication contains lactose, so it should not be administered to patients with lactose intolerance or hereditary lactose metabolic disorders. Patients with kidney or liver function issues should use this medication cautiously, as there is a risk of worsening liver function, which may require regular testing. Patients with heart disease or arrhythmia risk due to electrolyte disturbances should also exercise caution. This medication can affect heart rhythm, so cardiac monitoring may be necessary. This medication may interact with multiple drugs, so if you are taking other medications, dosage adjustments or monitoring may be needed. Generally, this medication has good tolerability, but rarely systemic reactions related to blood, liver, and kidney, as well as skin rashes, headaches, and gastrointestinal symptoms may occur. Pregnant women must use effective contraception during and for a period after taking this medication; it is safest not to use it during pregnancy. Breastfeeding women should also avoid this medication as it can be transmitted through breast milk. The safety of this medication for infants under 6 months has not been established, so it should be administered cautiously only when absolutely necessary. Caution should be exercised when driving or operating machinery, as dizziness or seizures may occur. In case of overdose, hallucinations or abnormal behaviors may occur, and immediate help from medical personnel should be sought. Gastric lavage or supportive care may be required if necessary. This medication is primarily excreted via urine, so increasing urine output aids excretion. In severe cases, hemodialysis may be helpful.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsades de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, 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, asthenia, fever, hallucinations, paranoid behavior

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it should be kept at room temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the medication will be maintained and it can be securely used.

Appearance

Capsules with the upper part filled with white powder and colored dark blue, and the lower part light blue

Package unit

In-house packaging unit