Cefuroxime Axetil 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. Its activity against Gram-positive cocci is similar to or slightly worse than that of the first-generation cephalosporins, but it is quite stable against the b-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, and 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, and 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.

The main ingredient of this product is 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, (1RS)-1-acetoxyethyl ester.

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

For the following infections caused by sensitive bacteria: Lower respiratory tract infections: such as acute and chronic bronchitis and pneumonia. Upper respiratory tract infections: sinusitis, paranasal sinusitis, tonsillitis and pharyngitis. Skin and soft tissue infections: such as furuncle and impetigo. Gonorrhea: acute gonococcal urethritis and cervicitis.

Oral. 1 Adults: generally 0.5g per day; patients with lower respiratory tract infection: 1g per day; patients with simple lower urinary tract infection: 0.25g per day. Take it in 2 divided doses. The single-dose therapy dose for simple gonococcal urethritis is 1g. Children aged 25 to 12 years: Acute pharyngitis or acute tonsillitis: 20mg/kg per day according to body weight, taken in 2 divided doses, not exceeding 0.5g per day; Acute otitis media, impetigo: 30mg/kg per day according to body weight, taken in 2 divided doses, not exceeding 1g per day.

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.

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: Children under 5 years old are prohibited from using this product. Precautions for pregnancy and lactation: 1. No evidence of harm to the fetus was found in animal experiments, but there is a lack of sufficient data in human studies. Therefore, pregnant women should use this product with caution only when there is a clear indication. 2. This product can be excreted through breast milk, so lactating women should use it with caution or stop breastfeeding. This product is prohibited for children under 5 years old, and cefuroxime axetil suspension is recommended. Precautions for the elderly: The blood elimination half-life (t1/2β) of elderly patients (average age 84 years old) can be extended to about 3.5 hours, so the dosage or medication interval should be adjusted according to the renal function under the guidance of a doctor.

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.

Keep away from light, tightly sealed, and stored in a cool place (not exceeding 20°C).

0.125g (calculated as C16H16N4O8S)

24 months.

Suzhou Chung- HWA Chemical & Pharmaceutical Industrial Co., Ltd.

• Founded in:

  1993-04-27

• Address:

  No. 66, Yong'an Road, Suzhou High-tech Zone

• Tax NO.:

  913205056081966464

• Registered Funds:

  $25.5 million

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