Norfloxacin Capsules

This product is a fluoroquinolone antibacterial drug with a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic Gram-negative bacteria. It has good antibacterial activity against the following bacteria in vitro: most bacteria of the Enterobacteriaceae family, including Citrobacter, Enterobacter cloacae, Enterobacter aerogenes and other Enterobacter species, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. Norfloxacin also has antibacterial activity against multi-drug resistant bacteria in vitro. It also has good antibacterial effects on penicillin-resistant Neisseria gonorrhoeae, Haemophilus influenzae and Moraxella catarrhalis. Norfloxacin is a bactericide that acts on the A subunit of bacterial DNA helicase, inhibiting DNA synthesis and replication, leading to bacterial death. [Pharmacokinetics] Oral absorption is rapid but incomplete when fasting, about 30% to 40% of the dose; widely distributed in various tissues and body fluids, such as liver, kidney, lung, prostate, testicle, uterus, bile, sputum, blister fluid, blood, urine, etc., but not found in the central nervous system. The serum protein binding rate is 10% to 15%, and the blood elimination period (t1/2?) is 3 to 4 hours, which can be extended to 6 to 9 hours when renal function is impaired. After a single oral administration of 400mg and 800mg of this product, the blood drug concentration reaches the peak value after 1 to 2 hours, and the blood drug peak concentration (Cmax) is 1.4 to 1.6mg/L and 2.5mg/L respectively. The kidney (glomerular filtration and tubular secretion) and hepatobiliary system are the main excretion routes, 26% to 32% is excreted in the urine in the original form and less than 10% is excreted in the form of metabolites, and excretion from bile and (or) feces accounts for 28% to 30%. The pH of urine affects the solubility of this product. The solubility is the lowest at a urine pH of 7.5, and increases at other pH values.

The main ingredient of this product is norfloxacin

This product is a capsule, and the contents are white to light yellow powder.

It is suitable for urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid fever and other Salmonella infections caused by sensitive bacteria.

Oral 1. Acute simple lower urinary tract infection caused by Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis: 400 mg once, twice a day, for a course of 3 days. 2. The dosage for simple urinary tract infection caused by other pathogens is the same as above, and the course of treatment is 7 to 10 days. 3. The dosage for complicated urinary tract infection is the same as above, and the course of treatment is 10 to 21 days. 4. Simple gonococcal urethritis: 800 to 1200 mg once. 5. Acute and chronic prostatitis: 400 mg once, twice a day, for a course of treatment of 28 days. 6. Intestinal infection: 300 to 400 mg once, twice a day, for a course of treatment of 5 to 7 days. 7. Typhoid Salmonella infection: 800 to 1200 mg a day, divided into 2 to 3 times, for a course of treatment of 14 to 21 days.

1. Gastrointestinal reactions are common and may manifest as abdominal discomfort or pain, diarrhea, nausea or vomiting. 2. Central nervous system reactions may include dizziness, headache, drowsiness or insomnia. 3. Allergic reactions include rash and itchy skin. Occasionally, exudative erythema multiforme and angioneurotic edema may occur. A small number of patients have photosensitivity reactions. 4. Occasionally, the following may occur: (1) epileptic seizures, mental abnormalities, irritability, impaired consciousness, hallucinations, and tremors. (2) interstitial nephritis manifestations such as hematuria, fever, and rash. (3) phlebitis. (4) crystalluria, which is more common when high doses are used. (5) joint pain. 5. A small number of patients may experience elevated serum aminotransferases, elevated blood urea nitrogen, and decreased peripheral white blood cells, which are usually mild and transient.

Patients who are allergic to this product and fluoroquinolones are contraindicated.

Precautions for children: The safety of this product in infants and adolescents under 18 years of age has not been established. However, this product can cause joint lesions when used in several young animals. This product should not be used in children and adolescents under 18 years of age. Precautions for pregnancy and lactation: Reproduction studies have been conducted with monkeys, with doses as high as 10 times the human dose, and it was found that this product can cause abortion. The peak plasma concentration (Cmax) of this dose in monkeys is about twice that of humans. This product has not been proven to be teratogenic in animals. However, no appropriate and well-controlled studies have been conducted in pregnant women, so this product should not be used in pregnant women. There is still a lack of information on whether this product is secreted through breast milk. When a lactating woman uses 200 mg of this product, the drug cannot be detected in breast milk. However, due to the small study dose, and the fact that other varieties of this class of drugs are secreted through breast milk, coupled with the potential serious adverse reactions to newborns and infants, lactating women should avoid using this product or stop breastfeeding when using it. Precautions for the elderly: Elderly patients often have impaired renal function, and because this product is partially excreted through the kidneys, it needs to be used in a reduced dose.

1. Urine alkalinizing agents can reduce the solubility of this product in urine, leading to crystalluria and nephrotoxicity. 2. When this product is used in combination with theophylline, competitive inhibition of the cytochrome P450 binding site may lead to a significant reduction in the hepatic clearance of theophylline, a prolonged blood elimination half-life (t1/2?), an increase in blood drug concentration, and the appearance of symptoms of theophylline poisoning, such as nausea, vomiting, tremor, restlessness, excitement, convulsions, palpitations, etc. Therefore, theophylline blood drug concentration should be measured and the dose adjusted when used in combination. 3. Cyclosporine combined with this product can increase the blood drug concentration of the former. The blood concentration of cyclosporine must be monitored and the dose adjusted. 4. This product can enhance the anticoagulant effect of the latter when used with the anticoagulant warfarin. The patient's prothrombin time should be closely monitored when used in combination. 5. Probenecid can reduce the secretion of this product from the renal tubules by about 50%. When used in combination, it may cause toxicity due to the increased blood concentration of this product. 6. This product has an antagonistic effect with nitrofurantoin and is not recommended for combined use. 7. Multivitamins, or other preparations containing iron or zinc ions, and antacids containing aluminum or magnesium can reduce the absorption of this product. It is recommended to avoid co-administration. If it cannot be avoided, take it 2 hours before or 6 hours after taking this product. 8. Didanosine (DDI) can reduce the oral absorption of this product. Because its preparation contains aluminum and magnesium, it can chelate with fluoroquinolones, so it is not suitable for co-administration. 9. This product interferes with the metabolism of caffeine, resulting in reduced caffeine clearance, prolonged blood elimination half-life (t1/2?), and possible central nervous system toxicity.

Keep in a sealed container

0.1g

12 months

Beijing Great Wall Pharmaceutical Co., Ltd.

• Founded in:

  1984-03-15

• Address:

  No. 63, West Fourth Ring Road South, Fengtai District, Beijing

• Tax NO.:

  911101061021983293

• Registered Funds:

  15.15 million yuan

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