Fluconazole Injection

1. Pharmacology This product belongs to the azole antifungal drug. It has a wide antifungal spectrum. Oral and intravenous administration of this product is effective against fungal infections in humans and various animals, such as Candida infections (including systemic candidiasis in humans and animals with normal or impaired immunity), Cryptococcus neoformans infections (including intracranial infections), Malassezia furfur, Microsporum, Trichophyton, Epidermophyton, Blastomyces dermatitidis, Coccidioides immitis (including intracranial infections), Histoplasma capsulatum, F. fischeri, and Cladosporium carinii. The in vitro antibacterial activity of this product is significantly lower than that of ketoconazole, but the in vivo antibacterial activity of this product is significantly higher than that of the in vitro effect. The mechanism of action of this product is mainly to highly selectively interfere with the activity of fungal cytochrome P-450, thereby inhibiting the formation of ergosterol on the fungal cell membrane.

Chemical composition: Fluconazole.

This product is a colorless clear liquid.

This product is mainly used for patients with more severe conditions in the following indications: 1. Candidiasis: used to treat oropharyngeal and esophageal Candida infections; disseminated Candidiasis, including peritonitis, pneumonia, urinary tract infections, etc.; Candida vulvovaginitis. It can also be used to prevent Candida infections in bone marrow transplant patients receiving cytotoxic drugs or radiotherapy. 2. Cryptococcosis: used to treat new cryptococcosis other than meninges; when treating cryptococcal meningitis, this product can be used as a maintenance treatment drug after initial treatment with amphotericin B combined with flucytosine. 3. Coccidioidomycosis. 4. This product can also replace itraconazole for the treatment of blastomycosis and histoplasmosis.

Intravenous drip. Adults (1) Disseminated candidiasis: 0.4g for the first dose, then 0.2g once a day for 4 weeks, and at least 2 weeks after the symptoms are relieved. (2) Esophageal candidiasis: 0.2g for the first dose, then 0.1g once a day for at least 3 weeks, and at least 2 weeks after the symptoms are relieved. Depending on the treatment response, the dose can also be increased to 0.4g once a day. (3) Oropharyngeal candidiasis: 0.2g for the first dose, then 0.1g once a day for at least 2 weeks. (4) Candidal vulvovaginitis: single dose, 0.15g. (5) Cryptococcal meningitis: 0.4g once a day until the condition improves significantly, then 0.2-0.4g once a day for at least 10-12 weeks after the cerebrospinal fluid virus culture turns negative. Or: 0.4g once, twice a day, for 2 days, then 0.4g once a day, the course of treatment is the same as above. If the patient with renal insufficiency only needs to be given once, there is no need to adjust the dose; when multiple doses are required, the regular dose should be given on the first and second days, and the dose should be adjusted according to the creatinine clearance rate thereafter, as described in the following table: Creatinine clearance (ml/min) Dose>50 Regular dose 11-50 Half of the regular dose Patients undergoing regular dialysis Administer once after each dialysis Pediatric treatment has not yet been established. There are data reporting that the starting dose is 3-6mg/kg per day based on body weight, once a day, and the results are safe for treating a small number of pediatric patients aged 2 weeks to 14 years old.

1. Common gastrointestinal reactions include nausea, vomiting, abdominal pain or diarrhea. 2. Allergic reactions: may manifest as rash, and occasionally severe exfoliative dermatitis (often accompanied by liver damage) and exudative erythema multiforme. 3. Hepatotoxicity: Mild transient elevation of serum aminotransferase may occur during treatment, and symptoms of hepatotoxicity may occasionally occur, especially in patients with serious underlying diseases (such as AIDS and cancer). 4. Dizziness and headache may be seen. 5. Some patients, especially those with serious underlying diseases (such as AIDS and cancer), may have abnormal renal function. 6. Transient changes in peripheral blood test indicators such as neutropenia and thrombocytopenia may occasionally occur, especially in patients with serious underlying diseases (such as

Patients with a history of allergy to this product or other azole drugs are contraindicated.

Precautions for children: There is a lack of sufficient research data on the effects of this product on children. Although a small number of pediatric patients aged 2 weeks to 14 years old have not experienced adverse reactions when treated with a daily dose of 3-6 mg/kg (by body weight), it is still not suitable for children. Precautions for pregnancy and lactation: 1. In animal experiments, when this product is given to animals at high doses, miscarriage, increased stillbirths, rib deformities in young animals, cleft palate and other changes may occur. Although such conditions have not been found in humans, pregnant women should still not use it. 2. There is no data on the concentration of this product in breast milk, so lactating women should use it with caution or stop breastfeeding when taking this product. Precautions for the elderly: Elderly patients with no renal function impairment do not need to adjust the dose. Elderly patients with renal impairment should adjust the dose according to creatinine clearance (see [Usage and Dosage] for details).

1. When this product is used in combination with isoniazid or rifampicin, the concentration of this product may be reduced. 2. When this product is used in combination with sulfonylurea hypoglycemic drugs such as tolbutamide, chlorbutamide and glipizide, the blood concentration of these drugs may increase, which may lead to hypoglycemia. Therefore, it is necessary to monitor blood sugar and reduce the dose of sulfonylurea hypoglycemic drugs. 3. When high doses of this product are used in combination with cyclosporine, the blood concentration of cyclosporine may increase, increasing the risk of toxic reactions. Therefore, it must be used with caution while monitoring the blood concentration of cyclosporine and adjusting the dose. 4. When this product is used in combination with hydrochlorothiazide, the blood concentration of this product may increase. 5. When this product is used in combination with theophylline, the blood concentration of theophylline may increase by about 13%, which may lead to toxic reactions. Therefore, theophylline needs to be monitored.

Keep away from light and store in a sealed container.

100 ml: 200 mg