Amoxicillin Sodium and Sulbactam Sodium for Injection

Pharmacological action: This compound is composed of amoxicillin sodium and sulbactam sodium. Amoxicillin is a bactericidal broad-spectrum antibiotic, and sulbactam sodium is an irreversible broad-spectrum beta-lactamase inhibitor, which can effectively inhibit beta-lactamase produced by drug-resistant bacteria. Clinically, many Gram-positive and Gram-negative bacteria produce beta-lactamase, which can make amoxicillin lose its antibacterial activity. Due to the presence of sulbactam sodium, amoxicillin can be protected from the destruction of beta-lactamase, so that bacteria that are resistant to amoxicillin and produce beta-lactamase are still sensitive to amoxicillin. This product is a bactericidal antibiotic. It can kill a variety of Gram-positive and Gram-negative bacteria in clinical practice, especially against drug-resistant bacteria that produce beta-lactamase. These bacteria include: Gram-positive bacteria: Aerobic bacteria: Staphylococcus aureus, Streptococcus faecalis, Staphylococcus epidermidis, Listeria monocytogenes, Streptococcus pyogenes, Corynebacterium, Streptococcus viridans, and Pneumococcus. Anaerobic bacteria: Clostridium, Peptostreptococcus, and Peptococcus. Gram-negative bacteria: Aerobic bacteria: Escherichia coli, Brucella, Proteus mirabilis, Haemophilus influenzae, Common Proteobacterium, Meningococcus, Klebsiella, Neisseria gonorrhoeae, Salmonella, Haemophilus ducreyi, Shigella, Branhamella, Pertussis, and Pasteurella multocida. Anaerobic bacteria: Bacteroides, including Bacteroides fragilis. Toxicological studies: There is currently no research data on the genetic toxicity, reproductive toxicity, and carcinogenicity of this compound. Animal reproductive toxicity tests showed that amoxicillin at 10 times the human dose did not impair the fertility or fetuses of rats and mice; sulbactam at 10 times the human dose did not impair the fertility or fetuses of rats, mice and rabbits.

This product is a compound preparation, and its components are amoxicillin sodium and sulbactam sodium. Chemical name: Amoxicillin sodium: (2S, 5R, 6R)-3,3-dimethyl-6-(R)-(-)-2-amino-2-(4-hydroxyphenyl)-acetylamino 7-oxo-4-thia-1-azabicyclo 3.2.0 heptane-2-carboxylate sodium. Sulbactam sodium: (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo 3.2.0 heptane-2-carboxylate sodium-4,4-dioxide.

This product is white or off-white powder. The solution after dissolution is colorless or light yellow.

This product contains the β-lactamase inhibitor - sulbactam, which is suitable for the following infectious diseases caused by enzyme-producing resistant bacteria, including: 1. Upper respiratory tract infections: such as ear, nose and throat infections, namely otitis media, sinusitis, tonsillitis and pharyngitis; 2. Lower respiratory tract infections: such as pneumonia, acute bronchitis and acute exacerbation of chronic bronchitis, bronchiectasis, empyema, lung abscess; 3. Urinary and reproductive system infections: such as pyelonephritis, cystitis and urethritis; 4. Skin and soft tissue infections: such as cellulitis, wound infection, furunculosis, purulent dermatitis and impetigo; sexually transmitted diseases: gonorrhea; 5. Pelvic infections: gynecological infections, postpartum infections, etc.; 6. Oral abscesses: such as surgical medications; 7. Severe systemic infections: such as meningitis, bacterial endocarditis, peritonitis, osteomyelitis, typhoid and paratyphoid, prevention of endocarditis, etc.

Intravenous drip: Dissolve with appropriate amount of injection water or sodium chloride injection before use, then add 100ml of 0.9% sodium chloride injection and drip intravenously. Each drip time should be no less than 30 to 40 minutes. Adult dose: 0.75g (amoxicillin 0.5g, sulbactam 0.25g) to 1.5g (amoxicillin 1.0g, sulbactam 0.5g) each time, 3 to 4 times a day

This product is usually well tolerated, and common adverse reactions are: 1. Gastrointestinal reactions: such as diarrhea, nausea, vomiting, etc.; 2. Skin reactions: erythematous maculopapular lesions, urticaria, etc.; 3. Allergic reactions: such as rash, lip swelling and oral mucosal ulceration, etc.; 4. Others: transient SGPT increase, etc. The above gastrointestinal reactions and skin reactions are more common in hypersensitive patients, which are generally mild and short-lived, and will disappear automatically or after stopping the drug. People who are allergic to penicillin may have severe allergic reactions.

It is contraindicated for patients who are allergic to penicillins.

Sulfonamide, aspirin, indomethacin, sulfonamides, etc. can reduce the secretion of amoxicillin by the renal tubules, reduce the excretion of amoxicillin, and increase the blood concentration of amoxicillin. Chloramphenicol, erythromycin, tetracycline, and sulfonamide antibiotics can affect the bactericidal effect of penicillin drugs and should not be used in combination with this product. This product is incompatible with heavy metals, especially copper, zinc, and mercury.

Keep in a light-proof and airtight container.

3.0g (C16H19N3O5S2.0g and C8H11NO5S1.0g)

North China Pharmaceutical Company.Ltd

• Founded in:

  1992-12-20

• Address:

  No. 388, Heping East Road, Shijiazhuang City

• Tax NO.:

  91130100104397700P

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  1,715,730,370 yuan

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