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.

Fluconazole

Fluconazole is a white or off-white crystalline powder, slightly soluble in water.

It is suitable for the following fungal diseases: 1. Systemic candidiasis: including candidemia, disseminated candidiasis and other forms of invasive candidal infections, such as peritoneal, endocardial, lung and urinary tract infections. It can also be used for patients with malignant tumors, special care patients, patients receiving radiotherapy, chemotherapy or immunosuppressive therapy or other factors that are susceptible to candidal infections. 2. Cryptococcosis:

The plasma elimination half-life is long, so only a single dose is needed to treat vaginal candidiasis; when treating other fungal infections, only one dose is needed per day, and the administration time should be continued until clinical symptoms and signs disappear or laboratory tests indicate that the fungal infection has disappeared. Insufficient medication time may lead to recurrence of infection. Patients with AIDS, cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance treatment to prevent recurrence. Adults: 1. For cryptococcal meningitis and cryptococcal infections in other parts, the usual dose is 0.4g on the first day and 0.2-0.4g per day thereafter. The course of treatment depends on the clinical and mycological response after taking the medicine, but for cryptococcal meningitis, the treatment period is generally 6-8 weeks after the cerebrospinal fluid bacterial test turns negative. To prevent the recurrence of cryptococcal meningitis in patients with AIDS, after the patient completes a course of basic treatment, fluconazole can be continued as maintenance treatment, with a daily dose of 0.2g for 10-12 weeks. 2. Candidemia, disseminated candidiasis and other invasive candidal infections: The usual dose is 0.4g on the first day and 0.2g on the next day. Depending on the clinical response, the daily dose can be increased to 0.4g. The course of treatment also depends on the clinical response. 3. Oropharyngeal candidiasis: The usual dose is 50mg once a day for 7 to 14 consecutive days. For patients with severe immunocompromise, the course of treatment can be extended as needed. For atrophic oral candidiasis associated with dentures, the usual dose is 50mg once a day for 14 consecutive days, and local anti-infection treatment is given at the denture site at the same time. For other mucosal candidal infections, such as esophagitis, non-invasive bronchial infections, lung infections, candiduria, chronic mucosal and cutaneous candidiasis, etc., the usual dose is 50mg once a day for 14 to 30 consecutive days. For extremely refractory cases of the above mucosal candidal infections, the dose can be increased to 0.1g once a day. 4. Vaginal candidiasis: 0.15g single dose orally. 5. To prevent fungal infection in patients with malignant tumors, patients can take 50mg of Diflucan orally once a day when receiving chemotherapy or radiotherapy. 6. Dermatophyte infection: For tinea manuum, tinea pedis, tinea corporis, tinea cruris, tinea capitis and candidal infection of the skin, the recommended dose is 0.15g once a week or 50mg once a day, and the course of treatment is generally 2 to 4 weeks; but the course of treatment for tinea pedis can be extended to 6 weeks; for tinea versicolor, the recommended dose is 50mg once a day, and the course of treatment is 2 to 4 weeks, and the course of treatment for tinea capitis is 6 to 8 weeks. 7. Onychomycosis of fingers and toes: 0.15g once a week, and the course of treatment is 2 to 4 months. The course of treatment can be appropriately extended depending on the condition. 8. Chromomycosis: 0.4 to 0.6g a day, and the course of treatment is 4 to 6 months. The course of treatment can be appropriately extended depending on the condition. Research data reports that the maximum daily dose can be increased to 0.8mg. Elderly: For those without renal impairment, the normal adult dose can be used; for those with renal impairment (creatinine clearance <40 ml/min), the dosing regimen should be adjusted accordingly according to the degree of impairment. See below for details. Patients with impaired renal function: Most of the drug is excreted unchanged in the urine. Therefore, there is no need to adjust the dose for treatments that require only one dose. If multiple doses are required, a regular dose should be given, and then the dosing interval or daily dose should be adjusted according to the creatinine elimination rate. The detailed method is as follows: Creatinine clearance (ml/min) Dosing interval/daily dose >4024 hours (regular dose) 21 to 4048 hours or half of the regular dose 10 to 2072 hours or 1/3 of the regular dose Patients undergoing regular dialysis each dialysis Post-administration 1 time Pediatric use: Recent research data from abroad reported that through pharmacokinetic studies on 70 children with tumor chemotherapy, bone marrow transplantation, immunodeficiency, and 12 premature infants and low-weight newborns, the half-life of fluconazole in the blood and heart of children under 16 years old is different from that of adults, namely: 73.7 hours for 1 day old; 53.2 hours for 1 week old; 46.6 hours for 2 weeks old; 21.7 hours for 3 months to 2 years old; 20.9 hours for 2 years old to 12 years old; 23.5 hours for 12 years old to 16 years old. Other pharmacokinetic parameters (such as bioavailability, distribution volume, etc.) are similar to those of adults, so the recommended doses for children of different ages are as follows: Children aged ＞4 weeks: mucosal fungal infection: 3 mg/kg body weight/day, once a day; deep systemic fungal infection: 6 mg/kg body weight/day, once a day; severe life-threatening infection: 12 mg/kg body weight/day, once a day. Children aged 2 to 4 weeks: kg body weight dose as above, once every 2 days. Children aged < 2 weeks: kg body weight dose as above, once every 3 days. Fluconazole can be administered orally or intravenously (speed not exceeding 10 ml/min). The route of administration should be determined based on the patient's clinical condition. No dose change is required when switching from intravenous drip to oral administration, or vice versa. Fluconazole intravenous drip solution is prepared with 0.9% sodium chloride solution. Each 0.2g (100ml bottle) contains 15mmol each of Na? ? and Cl? ?. Therefore, the infusion rate should be considered for patients with sodium or fluid restriction. Fluconazole intravenous drip solution can be mixed with the following solutions: a) 20% glucose solution b) 5% glucose solution c) 10% glucose solution d) Ringer's solution e) Potassium chloride glucose solution f) Normal saline Although no incompatibility has been observed, it is not recommended to mix fluconazole with other drugs for drip infusion except for the above solutions.

Patients generally tolerate this product well. The most common side effects are gastrointestinal symptoms, including nausea, abdominal pain, diarrhea, and flatulence; followed by rash. Some patients, especially those with serious underlying diseases (such as AIDS and cancer), may experience changes in renal function and hematological parameters and abnormal liver function during treatment with fluconazole and other triazole antifungal drugs (see Warnings).

It is contraindicated in patients who are allergic to fluconazole or other triazole 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 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

Shandong FANGMING Pharmaceutical Group Co., Ltd.

• Founded in:

  2000-07-07

• Address:

  Fangming Section, Huanghe Road, Dongming County, Shandong Province

• Tax NO.:

  91371700724268643E

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