Fluconazole Capsules

1. Pharmacology This product belongs to the azole antifungal drugs. It has a wide antifungal spectrum. Oral and intravenous injection 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 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. 2. Toxicology This product is highly selective for the cytochrome P-450 enzyme that fungi depend on. Taking 0.5g of this product per day for 28 consecutive days has been shown to have no effect on the plasma testosterone concentration in men or the steroid hormone concentration in women of childbearing age.

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

The content of this product is white or off-white powder.

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 the occurrence of 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. 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.

Oral. Adults (1) Disseminated candidiasis: 0.4g for the first dose, 0.2g for each dose thereafter, once a day for at least 4 weeks, and for at least 2 weeks after symptom relief. (2) Esophageal candidiasis: 0.2g for the first dose, 0.1g for each dose thereafter, once a day for at least 3 weeks, and for at least 2 weeks after symptom relief. Depending on the response to treatment, the dose may be increased to 0.4g once a day. (3) Oropharyngeal candidiasis: 0.2g for the first dose, 0.1g for each dose thereafter, once a day for 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; if 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 plans have not yet been established. There are data reporting that the starting dose is 3-6 mg/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, 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 imidazole 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 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, which increases 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 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 warfarin and other dicoumarin anticoagulants, it can enhance the anticoagulant effect of dicoumarin anticoagulants and prolong the prothrombin time, so 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, dry place.

50mg

24 months

Qilu Pharmaceutical Co., Ltd.

• Founded in:

  1992-08-21

• Address:

  No. 317, Xinluo Street, High-tech Zone, Jinan City, Shandong Province

• Tax NO.:

  91370000614073351Q

• Registered Funds:

  600 million yuan

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