Sulbactam Sodium for Injection

This product is a semi-synthetic beta-lactamase inhibitor with strong antibacterial activity against Neisseria gonorrhoeae, Neisseria meningitidis and Acinetobacter calcoaceticus, and poor effects on other bacteria, but it has a strong and irreversible competitive inhibitory effect on β-lactamase produced by Staphylococcus aureus and most Gram-negative bacteria. A concentration of 2 mg/L has a strong inhibitory effect on Richmond classification type II, III, IV and V β-lactamases, but has a poor effect on type I β-lactamases. When used in combination with penicillins and cephalosporins, the MIC of Staphylococcus aureus, Haemophilus influenzae, Escherichia coli, Bacteroides fragilis, etc., which are resistant to the first two types of antibiotics due to enzyme production, is reduced to within the sensitive range. This product has a strong affinity for PBP1 of Bacillus mirabilis and PBP2 of Acinetobacter calcoaceticus.

The main ingredient of this product is sulbactam sodium, and its chemical name is (2S,5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate sodium-4,4 dioxide. Molecular formula: C8H10NNaO5S Molecular weight: 255.23

This product is white or off-white crystalline powder.

Half an hour after intramuscular injection of 0.5g and 1.0g, the peak blood concentration (Cmax) was 13mg/L and 28mg/L respectively, and 0.5g and 1.0g were intravenously dripped, and the peak blood concentration (Cmax) was 30mg/L and 68mg/L respectively. The blood elimination half-life (t1/2) was 1 hour. The protein binding rate was 38%. 85% of the dose was excreted through urine 24 hours after administration. The drug concentration in interstitial fluid and peritoneal fluid was equivalent to the blood concentration. This product can penetrate the inflamed meninges. It can pass through the placenta into the fetus and is also contained in breast milk.

This product is used with ampicillin in a 1:2 dosage ratio. For general infections, the adult dosage is 1-2 g sulbactam and 2-4 g ampicillin per day, divided into 2-3 intravenous drips or intramuscular injections; for mild infections, 0.5 g sulbactam and 1 g ampicillin per day, divided into 2 intravenous drips or intramuscular injections; for severe infections, the dosage can be increased to 3-4 g sulbactam and 6-8 g ampicillin per day, divided into 3-4 intravenous drips.

The incidence of adverse reactions of this product combined with ampicillin is about 10% or less, and only 0.7% of patients discontinue treatment. 3.6% of patients have pain at the injection site, and reactions such as phlebitis, diarrhea, and nausea occasionally occur. The incidence of rash is 1% to 6%. Occasionally, transient eosinophilia and elevated serum aminotransferase are seen. In very rare cases, exfoliative dermatitis and anaphylactic shock occur.

It is contraindicated for patients who are allergic to penicillins.

1. Probenecid, aspirin, indomethacin, phenylbutazone, and sulfonamides can reduce the excretion of this product from the kidneys. Therefore, when used in combination with this product, the blood concentration of the drug will increase, the excretion time will be prolonged, and the toxicity may also increase. 2. This product should not be used in combination with disulfiram (an acetaldehyde dehydrogenase inhibitor).

Keep tightly closed in a cool, dry place.

1.0g (calculated as C8H11NO5S)

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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