Ampicillin Sodium and Sulbactam Sodium for Injection

Ampicillin sodium is a penicillin antibiotic. Sulbactam sodium is a semi-synthetic β-lactamase inhibitor, which has strong antibacterial activity against Neisseria gonorrhoeae, Neisseria meningitidis and Acinetobacter calcoaceticus, and has very poor effects on other bacteria, but has a strong irreversible competitive inhibition of β-lactamase produced by Staphylococcus aureus and most Gram-negative bacteria. The combination of the two drugs not only protects ampicillin from enzymatic hydrolysis, but also expands its antibacterial spectrum, and has good antibacterial activity against enzyme-producing strains of Staphylococci, Acinetobacter and Bacteroides fragilis. This product is effective against Staphylococci, Streptococci, Pneumococci, Enterococci, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, including enzyme-producing strains.

This product is a compound preparation, its components are ampicillin sodium and sulbactam sodium.

This product is white or off-white powder or crystalline powder.

This product is suitable for respiratory tract, hepatobiliary system, urinary system, skin and soft tissue infections caused by β-lactamase-producing Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Staphylococcus, Escherichia coli, Klebsiella, Proteus mirabilis, Bacteroides fragilis, Acinetobacter, Enterococcus, etc. It is particularly suitable for mixed infections of aerobic and anaerobic bacteria, especially abdominal and pelvic infections. It is also effective for the above infections caused by ampicillin-sensitive bacteria. This product should not be used for infections caused by Pseudomonas aeruginosa, Citrobacter, Providencia, Enterobacter, Morganella and Serratia.

Deep intramuscular injection, intravenous injection or intravenous drip. Intravenous drip: Dissolve each dose in 50-100 ml of saline, Ringer's sodium lactate solution or other diluents and drip intravenously within 15-30 minutes. The diluent is sterile water for injection or other appropriate solutions (such as saline, Ringer's sodium lactate solution, etc.). This product decomposes quickly in weak acid glucose injection, and neutral liquid should be used as a solvent. Adults take 1.5-3g at a time (including ampicillin and sulbactam), once every 6 hours. The daily dose for intramuscular injection shall not exceed 6g, and the daily dose for intravenous administration shall not exceed 12g (the maximum daily dose of sulbactam shall not exceed 4g). Children should take 100-200mg/kg per day according to their body weight, divided into several doses.

According to data from 11,764 cases in the United States and Europe, less than 10% of patients had adverse reactions, of which only 0.7% stopped treatment due to serious adverse reactions. About 3.6% had pain at the injection site, diarrhea, nausea and other reactions occasionally occurred, and the incidence of rash was 1% to 6%. Occasionally, serum aminotransferase increased transiently. In very rare cases, exfoliative dermatitis and anaphylactic shock occurred. In addition, granulocytopenia and thrombocytopenia also occurred occasionally.

1. Patients who are allergic to penicillin antibiotics are prohibited from using this product. 2. Patients with infectious mononucleosis, cytomegalovirus infection, lymphocytic leukemia, lymphoma, etc. are prone to skin rashes when using this product, so it is not suitable for use.

1 When used in combination with chloramphenicol, the in vitro antibacterial effect on Haemophilus influenzae is different. Chloramphenicol has no antagonistic effect on this product at high concentrations (5-10 mg/L), and can weaken the bactericidal effect of ampicillin at low concentrations (1-2 mg/L). The antibacterial effect of ampicillin on Staphylococcus aureus in vitro can be inhibited by lincomycin. The in vitro antibacterial effect on Escherichia coli, Proteus and Enterobacter can be enhanced by kanamycin. Gentamicin can accelerate the in vitro bactericidal effect of ampicillin on group B streptococci. 2 This product is incompatible with the following drugs: amikacin sulfate, kanamycin sulfate, gentamicin sulfate, streptomycin, clindamycin phosphate, lincomycin hydrochloride, colistin sodium methanesulfonate, polymyxin

Sealed, stored in a cool, dark and dry place, validity period: 2 years

1.5 g

Shandong Erye Pharmaceutical Co., Ltd.

• Founded in:

  2017-07-18

• Address:

  East side of East Outer Ring Road, Dingtao District, Heze City (north of Runxin Fine Chemical Co., Ltd.)

• Tax NO.:

  91371727MA3F8JY08Q

• Registered Funds:

  112 million yuan

• Email:

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