Fluconazole Sodium Chloride Injection

This product belongs to the azole antifungal drugs. 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 mechanism of action of this product is mainly to highly selectively interfere with the activity of fungal cytochrome P-450, thereby inhibiting the biosynthesis of ergosterol on the fungal cell membrane.

The main ingredient of this product is fluconazole, and its chemical name is alpha-(2,4-difluorophenyl)-alpha-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazol-1-ylethanol.

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 maximum drip rate is about 200 mg/hour. Adults (1) Disseminated candidiasis: The first dose is 0.4g, then 0.2g once a day, for 4 weeks, and at least 2 weeks after the symptoms are relieved. (2) Esophageal candidiasis: The first dose is 0.2g, 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: The first dose is 0.2g, 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. For patients with renal insufficiency, if only one dose is needed, no dose adjustment is required; when multiple doses are required, regular doses should be given on the first and second days, and the dose should be adjusted according to creatinine clearance thereafter. Pediatric treatment has not yet been established. There are data reporting that the starting dose is 3-6mg/kg per day, once a day, for a small number of pediatric patients aged 2 weeks to 14 years, and the results are safe. Or follow the doctor's advice.

1. Common digestive tract reactions, manifested as nausea, vomiting, abdominal pain or diarrhea. 2. Allergic reactions: may manifest as rash, 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 hepatotoxic symptoms 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 neutropenia and thrombocytopenia in peripheral blood and other changes in hematological examination indicators 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 at a daily dose of 3-6 mg/kg (by body weight), it is still not suitable for children. Or follow the doctor's advice. Precautions for pregnancy and lactation: 1. In animal experiments, high doses of this product may cause miscarriage, increased stillbirths, rib deformities in young animals, cleft palate and other changes. 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.

1. When this product is used in combination with isoniazid or rifampicin, it may affect the blood concentration of this product. 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, 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 may increase, which may increase the risk of toxic reactions. Therefore, it must be used with caution when the blood concentration of cyclosporine is monitored and the dose is adjusted. 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, 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. Therefore, 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, the blood concentration of midazolam can be significantly increased, and psychomotor effects may occur. 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 observed. 9. The combination of this product and cisapride may cause adverse cardiac reactions, including torsades de pointes. Patients receiving fluconazole treatment are prohibited from taking cisapride in combination. 10. When this product is used in combination with tacrolimus, it may increase the blood concentration of tacrolimus, which may lead to renal toxicity. Patients who are taking fluconazole and tacrolimus together should be closely observed. 11. When this product is used in combination with terfenadine at a daily dose of 400 mg or higher, the plasma concentration of terfenadine can be significantly increased. Fluconazole 400 mg or higher doses are prohibited to be used in combination with terfenadine. When fluconazole is administered at a daily dose of less than 400 mg and is used in combination with terfenadine, the blood concentration of terfenadine should be closely monitored. 12. When this product is used in combination with zidovudine, the blood concentration of the latter can be increased, and the occurrence of adverse reactions related to zidovudine should be observed. 13. When this product is used in combination with astemizole or other drugs metabolized by the cytochrome P-450 system, the serum concentration of these drugs can be increased. In the absence of clear data, these drugs should be used with caution and patients should be closely observed when used in combination with fluconazole. Doctors should pay attention to 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

Sichuan Kelun Pharmaceutical Co., Ltd.

• Founded in:

  2002-05-29

• Address:

  South 2nd Road, Xindu Satellite City Industrial Development Zone, Chengdu

• Tax NO.:

  9151010020260067X4

• Registered Funds:

  1,601,497,373 yuan

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