Ingredient: The main component of this product is Norfloxacin. Its chemical name is 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-1,8-naphthyridine-3-carboxylic acid sesquihydrate.

Chemical structure:

Molecular formula: C5H17FN4O3·3/2H2O Molecular weight: 347.35

Description: This product is a colorless or slightly yellow clear liquid.

Indications: Suitable for infections caused by susceptible bacteria, including:

1. Urinary and reproductive system infections, including uncomplicated and complicated urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis or cervicitis (including strains producing beta-lactamase).

2. Respiratory tract infections, including acute exacerbations of bronchial infections caused by susceptible Gram-negative rods and lung infections.

3. Gastrointestinal infections caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, hydrophilic Pseudomonas aeruginosa, Vibrio parahaemolyticus, and other pathogens.

4. Typhoid fever.

5. Bone and joint infections.

6. Skin and soft tissue infections.

7. Systemic infections such as sepsis.

Specification: 2ml: 0.1g

【Dosage and Administration】 Dissolve 0.2g in 100ml of 5% glucose injection and administer intravenously while avoiding light. Adults: 0.2g per dose, twice daily. The maximum daily dose for critically ill patients should not exceed 0.6g. The treatment duration is 7-10 days, and oral formulations can be used once the condition significantly improves.

【Adverse Reactions】

1. Gastrointestinal reactions: abdominal discomfort or pain, diarrhea, nausea, or vomiting.

2. Central nervous system reactions: dizziness, headache, drowsiness, or insomnia.

3. Allergic reactions: rash, itching, rarely exudative erythema multiforme and angioedema. Some patients may experience photosensitivity reactions.

4. Rarely occurring reactions include seizures, mental abnormalities, restlessness, confusion, hallucinations, and tremors. Interstitial nephritis, manifested as hematuria, fever, rash, etc. Vein inflammation. Crystalluria, which is more common with high-dose use. Joint pain. Facial flushing, palpitations, and chest tightness.

5. A small number of patients may experience elevated serum transaminases, increased blood urea nitrogen, and a temporary decrease in white blood cell count in peripheral blood, usually mild.

【Contraindications】 Contraindications include hypersensitivity to the drug or fluoroquinolones, tendinitis, tendon rupture, and deficiency of glucose-6-phosphate dehydrogenase.

【Precautions】

1. Currently, there is a high prevalence of resistance to fluoroquinolones in Escherichia coli. A urine culture should be obtained before administration to adjust the medication based on bacterial susceptibility results.

2. High-dose administration or urine pH above 7 may result in crystalluria. To prevent crystalluria, it is advisable to drink plenty of water and maintain a urine output of more than 1200ml in 24 hours.

3. Patients with impaired renal function should adjust the dosage based on their renal function.

4. The use of fluoroquinolones can cause moderate to severe photosensitivity reactions. Avoid excessive exposure to sunlight while using this medication, and discontinue use if photosensitivity reactions occur.

5. In cases of severe hepatic impairment, such as liver cirrhosis with ascites, drug clearance may be reduced, resulting in increased blood drug concentration. In patients with impaired liver and renal function, this effect is particularly evident, and the benefits and risks should be carefully considered before use, with dosage adjustments if necessary.

6. Patients with pre-existing central nervous system disorders, such as epilepsy or a history of seizures, should avoid using the drug. If indicated, careful consideration of the benefits and risks should be made before use.

【Use in Pregnancy and Lactation】 Animal studies have not demonstrated teratogenic effects of quinolone class drugs, but there is no definitive conclusion on the use of this drug in pregnant women. Considering the potential for joint lesions in immature animals, it is contraindicated in pregnant women, and lactating women should suspend breastfeeding when using this drug.

【Use in Children】 The safety of this drug in infants, young children, and adolescents under 18 years old has not been established. However, when used in several young animals, it can cause joint lesions. Therefore, it is not suitable for children and adolescents under 18 years old.

【Use in the Elderly】 Elderly patients often have impaired renal function, and as this drug is partially excreted by the kidneys, dosage reduction is necessary.

【Drug Interactions】

1. Urine alkalinizers can decrease the solubility of this drug in urine, leading to crystalluria and renal toxicity.

2. Concurrent use of this drug with theophylline may result in competitive inhibition at the cytochrome P450 binding site, leading to a significant decrease in the hepatic elimination of theophylline. This prolongs the blood elimination half-life (t1/2β), increases blood drug concentration, and may cause theophylline toxicity symptoms such as nausea, vomiting, tremors, restlessness, agitation, seizures, and palpitations. Co-administration should be avoided, but if unavoidable, the blood drug concentration of theophylline should be monitored and the dosage adjusted accordingly.

3. When used together with cyclosporine, the blood drug concentration of cyclosporine increases, necessitating monitoring of cyclosporine blood levels and dosage adjustment.

4. Concurrent use of this drug with the anticoagulant warfarin can enhance its anticoagulant effect. Therefore, their combination should be avoided. If unavoidable, the patient's prothrombin time should be closely monitored, and the dosage adjusted accordingly.

5. Probenecid can reduce the renal tubular secretion of this drug by approximately 50%. Co-administration can increase the blood concentration of this drug and cause toxicity.

6. This drug interferes with the metabolism of caffeine, leading to reduced caffeine elimination and prolongation of the blood elimination half-life (t1/2β). This may result in central nervous system toxicity. Therefore, the combination of this drug with caffeine should be avoided. If unavoidable, the patient's blood drug concentration of caffeine should be closely monitored, and the dosage adjusted accordingly.

7. Rare cases of seizures have occurred when this drug is used in combination with the nonsteroidal anti-inflammatory drug fenbufen. Therefore, co-administration with fenbufen is not recommended.

【Pharmacology and Toxicology】

This drug has a broad-spectrum antibacterial effect, especially against aerobic Gram-negative bacilli. In vitro, it exhibits good antibacterial activity against the following bacteria: most members of the Enterobacteriaceae family, including Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus species, Salmonella species, Shigella species, Vibrio species, Yersinia species, etc. It also has antibacterial activity against multidrug-resistant bacteria. It has a high level of antibacterial activity against penicillin-resistant Neisseria gonorrhoeae, beta-lactamase-producing Haemophilus influenzae, and Moraxella species. It has antibacterial activity against most strains of Pseudomonas species, including Pseudomonas aeruginosa. It exhibits antibacterial activity against methicillin-sensitive Staphylococcus aureus and moderate antibacterial activity against Streptococcus pneumoniae, Streptococcus pyogenes, and Enterococcus species. It has good antimicrobial activity against Chlamydia trachomatis, Mycoplasma species, Legionella species, and also exhibits antibacterial activity against Mycobacterium tuberculosis and non-tuberculous mycobacteria. It has poor activity against anaerobic bacteria. Enrofloxacin acts as a bactericidal agent by inhibiting the A subunit of bacterial DNA gyrase, thereby inhibiting DNA synthesis and replication, leading to bacterial death.

【Pharmacokinetics】

After intravenous administration of 0.2g and 0.4g, the peak blood concentration (Cmax) of the drug is reached at approximately 1 hour. The blood elimination half-life (t1/2β) is approximately 3-6 hours. The protein binding rate ranges from 18% to 57%. After absorption, the drug is widely distributed to various tissues and body fluids, with concentrations in tissues often exceeding blood drug concentrations and reaching effective levels. The drug is mainly eliminated through renal excretion, with 52%-60% of the administered dose excreted unchanged in urine within 48 hours, and a portion (20%) metabolized in the body. Approximately 18% is excreted in bile.

【Storage】 Store in a light-resistant, closed container at 10-30°C.

【Packaging】 Ampoules, 8 supports per box.

【Shelf Life】 24 months

【Standard】 YBH00702012

【Approval Number】 National Medical Products Administration (NMPA) Approval Number: H20050530