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 and irreversible competitive inhibitory effect on 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 Staphylococcus, Acinetobacter and Bacteroides fragilis. This product has antibacterial activity against Staphylococci, Streptococci, Pneumococci, Enterococci, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Fusobacterium, Peptococcus, Peptostreptococcus and Bacteroides including Bacteroides fragilis.

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

This product is suitable for respiratory tract, hepatobiliary system, urinary system, skin and soft tissue infections caused by (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-mentioned 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. Dissolve each dose in 50-100 ml of appropriate diluent and drip intravenously within 15-30 minutes. Adults take 1.5-3 g (including ampicillin and sulbactam) once every 6 hours. The daily dose for intramuscular injection shall not exceed 6 g, and the daily dose for intravenous administration shall not exceed 12 g (the maximum daily dose for sulbactam shall not exceed 4 g). Children take 100-200 mg/kg per day according to 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.

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 antibacterial effect on Haemophilus influenzae in vitro varies. 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. Gentamycin 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 B, succinic chloramphenicol, erythromycin ethylsuccinate and erythromycin lactobionate, tetracycline injection, neomycin, epinephrine, metaraminol, dopamine, atropine, hydralazine hydrochloride, hydrolyzed protein, calcium chloride, calcium gluconate, vitamin B group, vitamin C, nutrient injection containing amino acids, polysaccharides (such as dextran 40) and hydrocortisone sodium succinate. These drugs can reduce the activity of ampicillin. 3 This product is incompatible with heavy metals, especially copper, zinc and mercury, because the latter can destroy its oxidized thiazole ring. Rubber tubes or bottle stoppers made of zinc compounds can also affect its activity. It can also be inactivated by oxidants, reducing agents or hydroxyl compounds. 4 This product decomposes quickly in weakly acidic glucose injection, so neutral liquid should be used as solvent. 5 This product can enhance the effect of warfarin. 6 When allopurinol is used in combination with this product, the incidence of rash increases significantly, especially in hyperuricemia, so it should be avoided in combination with allopurinol. 7 When chloramphenicol is used in combination with this product for bacterial meningitis, the incidence of long-term sequelae is higher than when either is used alone. 8 Probenecid, aspirin, indomethacin, phenylbutazone, and sulfonamides can reduce the excretion of this product from the kidneys, so when used in combination with this product, its blood drug concentration increases, the excretion time is prolonged, and the toxicity may also increase. 9 This product should not be used in combination with disulfiram (acetaldehyde dehydrogenase inhibitor). 10 This product can stimulate estrogen metabolism or reduce its enterohepatic circulation, thereby reducing the effectiveness of oral contraceptives.

Keep away from light and store in a cool, dark and dry place.

3.0g

Hainan Meimei Xilin Biopharmaceutical Co., Ltd.

• Founded in:

  2007-12-24

• Address:

  Factory Building No. 26, Guilinyang Development Zone, Meilan District, Haikou City

• Tax NO.:

  91460000798744593P

• Registered Funds:

  10 million yuan

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