Fluconazole Tablets

This product belongs to the azole antifungal drugs. It has a wide antifungal spectrum. Oral and intravenous injection of this product is effective for 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 in vitro effects. 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 α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazol-1-ylethanol. Its chemical structure is: Molecular formula: C13H12F2N6O Molecular weight: 306.28

This product is white or off-white tablets.

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 therapy after initial treatment with amphotericin B combined with flucytosine. 3. Coccidioidomycosis. 4. Used for preventive treatment of patients receiving chemotherapy, radiotherapy and immunosuppressive therapy. 5. This product can also replace itraconazole for the treatment of blastomycosis and histoplasmosis.

1 Disseminated candidiasis: The first dose is 0.4g, followed by 0.2g once a day for at least 4 weeks, and lasts for at least 2 weeks after the symptoms are relieved. 2 Esophageal candidiasis: The first dose is 0.2g, followed by 0.1g once a day for at least 3 weeks, and lasts for 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, followed by 0.1g once a day, and the course of treatment is at least 2 weeks. 4 Candidal vulvovaginitis: Single dose, 0.15g. 5 Prevention of candidiasis: 0.2-0.4g once a day for those with indications for preventive medication. If patients with renal insufficiency only need to be given once, there is no need to adjust the dose; multiple doses are required.

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. 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 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).

Elderly patients with no renal function impairment do not need to adjust the dose. Elderly patients with renal function impairment need to adjust the dose according to creatinine clearance. 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 were treated with a daily dose of 3-6 mg/kg (by body weight) without adverse reactions, it is still not suitable for children. In animal experiments, when this product is given to animals at high doses, changes such as miscarriage, increased stillbirths, rib deformities in young animals, and cleft palate may occur. Although such conditions have not been found in humans, pregnant women should still not use it. 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. It is contraindicated for those with a history of allergy to this product or other azole drugs.

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, cleft palate and other changes in young animals 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 normal renal function do not need to adjust the dose. Elderly patients with impaired renal function must adjust the dose according to creatinine clearance.

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 may increase, which may lead to hypoglycemia. Therefore, blood sugar should be monitored and the dose of sulfonylurea hypoglycemic drugs should be reduced. 3. When a high dose of this product is 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 when the blood concentration of cyclosporine is monitored and the dose is adjusted. Application 4 When this product is used in combination with hydrochlorothiazide, 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 cause toxic reactions, so 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.

Sealed, store in a cool and dry place

0.15g

24 months.

Shijiazhuang No.4 Pharmaceutical Co., Ltd.

• Founded in:

  1994-06-28

• Address:

  No. 518, Huaian East Road, Shijiazhuang High-tech Industrial Development Zone

• Tax NO.:

  911301001044060055

• Registered Funds:

  950 million yuan

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