Fluconazole Capsules

Fluconazole is a new triazole antifungal drug with a broad-spectrum antifungal effect and can selectively inhibit fungal sterol synthesis. Oral and intravenous injections are 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 sacchari, Microsporum, Trichophyton, Epidermophyton, Blastomyces dermatitidis, Coccidioides immitis (including intracranial infections), Histoplasma capsulatum, Peyer's Chromatiaceae, and Cladosporium carinii. Fluconazole is highly selective in its inhibitory effect on fungal cytochrome p-450-dependent enzymes. Studies have shown that fluconazole 50 mg once a day for 28 consecutive days has no effect on male plasma testosterone concentrations or plasma steroid concentrations in women of childbearing age; fluconazole 0.2-0.4 g once a day has no significant effect on endogenous steroid levels or adrenocorticotropic hormone effects in healthy male volunteers. Drug interaction studies have shown that single or multiple doses of fluconazole 50 mg have no effect on the metabolism of antipyrine.

The main ingredient of this product is fluconazole

White or off-white crystalline powder, slightly soluble in water.

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 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.

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.

Patients generally tolerate this product well. Common adverse reactions include nausea, abdominal pain, diarrhea, flatulence, rash, and occasional elevated alanine aminotransferase. Contraindications Patients with a history of allergy to this product or other triazole drugs should not use it.

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.

Store below 30°C.

50mg

24 months

Chongqing KERUI Pharmaceutical (GROUP) Co., Ltd.

• Founded in:

  1999-03-03

• Address:

  No. 2 Dashizhi Road, Nan'an Economic and Technological Development Zone, Chongqing

• Tax NO.:

  915001082031636780

• Registered Funds:

  110.6375 million yuan

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