Diflucan Injection 100mg (Fluconazole)

Adult dosage

The route of administration is determined according to the patient's clinical condition. Because the oral formulation is rapidly and almost completely absorbed, the doses of the oral formulations (capsules, dry syrup) and injection are the same. Administer this medicine intravenously at a rate of approximately 5 - 10 mL/min. 1. Adults 1) Mucosal candidiasis (1) 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. (2) Chronic atrophic oral candidiasis (oral soreness due to dentures) The usual dose is 50 mg of this medicine once daily for 14 days. The dentures should also be disinfected locally. (3) Other mucosal candidiasis (esophageal candidiasis, excluding vaginal candidiasis; noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc.) 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. 2) 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 depending on the patient's response. The duration of treatment is determined by the clinical response and medical judgment. 3) 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 is usually at least 6 - 8 weeks. 4) To prevent recurrence of cryptococcal meningitis in patients with AIDS, after completion of primary therapy, administer 200 mg of this medicine once daily indefinitely. 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 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 infection, such as bone marrow transplant patients with severe neutropenia or an expected prolonged period of neutropenia. In these patients, administer 400 mg beginning 5 - 6 days before the anticipated onset of neutropenia, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 3. Older adults Use the usual adult dose only if renal function is normal. In patients with renal impairment (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. 4. Patients with renal impairment This medicine is excreted mainly in the urine in unchanged form. No dosage adjustment is necessary for 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) >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 without dialysis, administer a reduced dose according to creatinine clearance.

Children's dosage

2. Children Pediatric doses based on adult doses are generally determined according to the following guidelines and must 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 under 6 months of age have not been established (see Precautions). 1) Oropharyngeal candidiasis 6 mg/kg 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. 2) Esophageal candidiasis 6 mg/kg on the first day, followed by 3 mg/kg once daily from the next day; depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treat 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 once daily. The duration of treatment is determined by the clinical response and medical judgment. 4) Cryptococcal meningitis 12 mg/kg on the first day, followed by 6 mg/kg once daily from the next day; depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue 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 once daily after completion of primary therapy. 6) In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

This drug should not be administered to certain patients. Patients who have had allergic reactions to this drug or other azole medications, pregnant women or women who may become pregnant, and nursing mothers should not use this medication. Moreover, it may be risky to take in combination with certain medications affecting the heart, so consultation with a doctor is necessary. There are also situations where careful use of this drug is required. Patients with a history of allergies, impaired kidney or liver function, heart disease, or arrhythmia risk should exercise caution when using this drug. In particular, liver function may deteriorate, so liver status should be monitored regularly. Although this drug generally has fewer side effects, rare side effects such as blood abnormalities, allergic reactions, liver function abnormalities, and skin rashes may occur. Abnormal heart rhythms or gastrointestinal disturbances have also been reported, so if any unusual symptoms occur, immediate consultation with medical staff is necessary. Regular checks such as liver, kidney, and blood tests may be required during treatment with this drug. Pregnant women should avoid this medication as it may pose risks of adverse effects on the fetus, and it is also not recommended for nursing mothers. This drug can interact with several other medications, so if you are taking other medications, you must inform your healthcare professionals. Caution is especially needed when used with drugs that may affect the heart or those metabolized in the liver. Precautions should be taken while driving or operating machinery, as dizziness or seizures may occur. In case of overdose, hallucinations or abnormal behavior may arise, and immediate medical treatment is required. This drug should be administered mixed with the prescribed solution, and mixing with other medications or intravenous solutions is not recommended.

Eosinophilia, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia, Anaphylaxis, Angioedema, Hypertriglyceridemia, Hypercholesterolemia, Hypokalemia, Insomnia, Drowsiness, Headache, Seizures, Dizziness, Sensory Disturbances, Altered Taste, Tremors, Vertigo, Torsades de Pointes, QT Prolongation, Abdominal Pain, Diarrhea, Nausea, Vomiting, Dyspepsia, Bloating, Dry Mouth, Increased ALT, Increased AST, Elevated Blood Alkaline Phosphatase, Cholestasis, Jaundice, Increased Bilirubin, Hepatotoxicity, Liver 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, Myalgia, Fatigue, Lethargy, Weakness, Fever, Adrenal Insufficiency, Hallucinations, Paranoid Behavior

This medication should be stored in a sealed container to prevent air or moisture from entering, and the storage temperature should be kept between 1 and 30 degrees Celsius. Therefore, it is important to avoid extremely hot or cold places and to store safely at an appropriate temperature.

Appearance

A colorless, transparent liquid contained in a colorless, transparent vial

Package unit

50ml/vial X 1 vial