Fluconazole Sodium Chloride Injection

Fluconazole is a triazole broad-spectrum antifungal drug. It inhibits the reproduction and growth of fungi by highly selectively inhibiting the C-14-alpha;-demethylation of fungal cytochrome P-450 sterols, causing the accumulation of 14-alpha;-methyl sterols in fungi. In vitro tests show that this product has antibacterial activity against Cryptococcus neoformans and Candida species. Oral and intravenous injection of fluconazole in animals is effective in the following animal fungal infection models: Candida infection (including systemic candidiasis in immunodeficient animals); Cryptococcus neoformans infection (including intracranial infection); Microsporum and Trichophyton infection, etc. Fluconazole is also effective against Blastomyces dermatitidis infection and Coccidioides immitis infection (including intracranial infection); and is also effective against infections caused by Histoplasma capsulatum in normal animals and immunosuppressed animals. Genetic toxicity: The results of the Ames test, the mouse lymphoma L5178Y cell line test, the animal bone marrow micronucleus test, and the human lymphocyte chromosome test were all negative. Reproductive toxicity: Oral administration of fluconazole 20 mg/kg to rats can slightly delay the delivery process, but does not affect their fertility. Perinatal results in rats show that when female rats received 20 mg/kg and 40 mg/kg, some animals experienced dystocia and delayed delivery. The main manifestations were a slight increase in the number of stillbirths and a decrease in the number of surviving newborns. The effect of high-dose fluconazole on rat delivery may be related to its ability to specifically reduce the estrogen level of animals of this species. Such changes in hormone levels have not been observed in women treated with fluconazole. Carcinogenicity: The experiment was conducted on mice and rats. Mice and rats were orally administered fluconazole at a dose of 2.5, 5 or 10 mg/kg body weight/day (about 2-7 times the recommended human dose) for 24 months, indicating that fluconazole has no carcinogenic effect. However, male rats received this product at a dose of 5 mg/kg and 10 mg/kg for 24 consecutive months, and the incidence of hepatocellular adenoma in animals was increased.

The main ingredient of this product is 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 Candida vulvovaginitis such as peritonitis, pneumonia, and urinary tract infections. It can also be used to prevent the occurrence of Candida infections in bone marrow transplant patients receiving cytotoxic drugs or radiotherapy. 2. Cryptococcal disease: used to treat new cryptococci other than meninges; when treating cryptococcal meningitis, this product can be used as a maintenance treatment 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. The drip rate should not exceed 5 mg/min.

1 Common gastrointestinal reactions, manifested as 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 may occur. 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 Headache and dizziness may be seen. 5 Some patients, especially those with serious underlying diseases (such as AIDS and cancer), may have abnormal renal function. 6 Changes in hematological examination indicators such as transient neutropenia and thrombocytopenia in peripheral blood may occasionally occur, especially in patients with serious underlying diseases (such as AIDS and cancer).

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 suspend 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 can 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 can be increased, which may lead to hypoglycemia. Therefore, blood sugar needs to be monitored and the dose of sulfonylurea hypoglycemic drugs needs to be reduced. 3. When high doses of this product are used in combination with cyclosporine, the blood concentration of cyclosporine can be increased, leading to an increased 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 tissue thiazide, the blood concentration of this product can be increased. 5. When this product is used in combination with theophylline, the blood concentration of theophylline can be increased by about 13%, which can lead to toxic reactions. Therefore, the blood concentration of theophylline needs to be monitored. 6 When this product is used in combination with dicoumarin anticoagulants such as warfarin, it can enhance the anticoagulant effect of dicoumarin anticoagulants and prolong the prothrombin time. Therefore, the prothrombin time should be monitored and used with caution. 7 When this product is used in combination with phenytoin sodium, the blood concentration of phenytoin sodium can be increased, so the blood concentration of phenytoin sodium needs to be monitored. 8 When this product is used in combination with short-acting benzodiazepines such as midazolam, it can cause a significant increase in the blood concentration of midazolam and psychomotor effects. This effect is more obvious when taken orally than when injected intravenously. If the patient needs to receive fluconazole and benzodiazepines at the same time, the dosage of benzodiazepines should be reduced and the patient should be properly monitored. 9 Taking this product at the same time with cisapride may cause adverse cardiac reactions, including torsades de pointes. Patients receiving fluconazole treatment are prohibited from taking cisapride at the same time. 10 When this product is taken with tacrolimus, it may increase the blood concentration of tacrolimus, which may lead to renal toxicity. Patients who take fluconazole and tacrolimus at the same time should be closely monitored. 11 When this product is taken with terfenadine at a daily dose of 400 mg or more, it can significantly increase the plasma concentration of terfenadine. It is prohibited to take fluconazole 400 mg or more with terfenadine at the same time. When fluconazole is taken with terfenadine at a dose of less than 400 mg per person, the blood concentration of terfenadine should be closely monitored. 12 When this product is taken with zidovudine, it can increase the blood concentration of the latter, and the occurrence of adverse reactions related to zidovudine should be monitored. 13 When this product is taken with astemizole or other drugs metabolized by the cytochrome P-450 system, it can lead to an increase in the serum concentration of these drugs. In the absence of clear data, these drugs should be used with caution and patients should be closely monitored when taken with fluconazole. Physicians should be aware of other drug interactions that have not been studied but may occur.

Keep away from light and store in a sealed container.

100ml: Fluconazole 0.2g and sodium chloride 0.9g

24 months

Cisen Pharmaceutical Co., Ltd.

• Founded in:

  1998-11-06

• Address:

  Tongji Science and Technology Industrial Park, Jining High-tech Zone

• Tax NO.:

  91370800706117999P

• Registered Funds:

  452,754,129 yuan

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