Cefuroxime Axetil Dispersible Tablets

This product is a second-generation cephalosporin antibiotic. After oral absorption through the gastrointestinal tract, it is rapidly hydrolyzed into cefuroxime under the action of esterase to exert its antibacterial effect. The activity against Gram-positive cocci is similar to or slightly worse than that of the first-generation cephalosporins, but it is quite stable against beta-lactamase produced by Staphylococci and Gram-negative bacilli. Except for methicillin-resistant Staphylococci, Enterococci and Listeria, other positive cocci (including anaerobic cocci) are sensitive to this product. The antibacterial activity of this product against Staphylococcus aureus is worse than that of cefazolin. 1-2 mg/L of this product can inhibit all Staphylococcus aureus that are sensitive and resistant to penicillin, respectively. It has strong antibacterial activity against Haemophilus influenzae, Escherichia coli, Proteus mirabilis, etc. are sensitive to this product; indole-positive Proteus, Citrobacter and Acinetobacter are poorly sensitive to this product, most Serratia are resistant, Pseudomonas aeruginosa, Campylobacter and Bacteroides fragilis are resistant to this product. The mechanism of action of this product is to inhibit the synthesis of bacterial cell walls.

Cefuroxime axetil. Chemical name: 6R, 7R)-7-[2-furanyl(methoxyimino)acetylamino]-3-carbamoyloxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 1-acetoxyethyl ester.

This product is a film-coated tablet, which appears off-white after removing the coating.

This product is suitable for acute pharyngitis or tonsillitis in adults, acute otitis media, maxillary sinusitis, acute exacerbation of chronic bronchitis, acute bronchitis, simple urinary tract infection, skin and soft tissue infection, and uncomplicated gonorrhea Neisseria urethritis and cervicitis caused by sensitive strains of Enterobacteriaceae such as hemolytic streptococci, Staphylococcus aureus (except methicillin-resistant strains), Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. It is also suitable for pharyngitis or tonsillitis, acute otitis media, and impetigo in children.

Oral administration: 0.5g per day for adults; 1g per day for patients with lower respiratory tract infection; 0.25g per day for patients with simple lower urinary tract infection. Take it in two divided doses. The single-dose therapy dose for simple gonococcal urethritis is 1g. Children aged 5 to 12 years with acute pharyngitis or acute tonsillitis: 20mg/kg per day, divided into two doses, not exceeding 0.5g per day; acute otitis media, impetigo: 30mg/kg per day, divided into two doses, not exceeding 1g per day.

1. Common gastrointestinal reactions include diarrhea, nausea and vomiting. 2. Rare allergic reactions include rash and drug fever. 3. Occasionally, pseudomembranous colitis, eosinophilia, increased blood bilirubin, decreased hemoglobin, changes in renal function, positive Coombs test and transient increase in liver enzymes are seen.

1. Patients who are allergic to this product or other cephalosporins, those with a history of anaphylactic shock or immediate reaction to penicillin, and those with gastrointestinal absorption disorders are prohibited from using this product. Children under 25 years old are prohibited from using this product.

Precautions for children: Not for use in children under 5 years old. Precautions for pregnancy and lactation: Use with caution in pregnant women. Since cefuroxime is excreted in human milk, use with caution in lactating women. If use is necessary, breastfeeding should be temporarily stopped. Precautions for the elderly: Elderly patients do not need to adjust the dose based on age.

1. Furosemide, ethacrynic acid, bumetanide and other strong diuretics, carmustine, streptozocin and other anti-tumor drugs and aminoglycoside antibiotics and other nephrotoxic drugs combined with this product may increase nephrotoxicity. 2. Clavulanic acid can enhance the antibacterial activity of this product against certain Gram-negative bacteria that are resistant to this product due to the production of beta-lactamase. 3. This product combined with probenecid can increase the area under the drug-time curve (AUC value) of this product by about 50%. 4. This product combined with antacids can reduce the absorption of this product.

Protect from light, seal tightly and store in a cool place.

0.125g (calculated as C16H16N4O8S)

Tentative 24 months

Guangzhou Nucien Pharmaceutical Co., Ltd.

• Founded in:

  1993-09-17

• Address:

  Building 1-2, No. 196, Kaiyuan Avenue, Luogang District, Guangzhou

• Tax NO.:

  91440101618440809W

• Registered Funds:

  65.25 million yuan

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