Piperacillin Sodium and Sulbactam Sodium for Injection

Pharmacological action: This product is a compound preparation of piperacillin sodium and sulbactam sodium in a ratio of 4:1. Piperacillin is a broad-spectrum penicillin antibiotic that kills bacteria by interfering with the synthesis of bacterial cell walls. It is mainly used for infections caused by Pseudomonas aeruginosa and various Gram-negative bacilli, but it is easily hydrolyzed by β-lactamase produced by bacteria to produce drug resistance; sulbactam has no antibacterial activity against other bacteria except Neisseria and Acinetobacter, but sulbactam has an irreversible inhibitory effect on most important β-lactamases produced by β-lactam antibiotic-resistant strains. Sulbactam can prevent drug-resistant bacteria from destroying penicillins and cephalosporins, and sulbactam has a significant synergistic effect with penicillins and cephalosporins. Toxicological study: Repeated dose toxicity: Rats were intraperitoneally injected with this product for 8 weeks continuously, and the dose without toxic reaction was 1g/kg; the 2g/kg group occasionally had loose stools, diarrhea, and slightly enlarged liver and spleen; the 4g/kg group had loose stools, diarrhea, and increased aspartate aminotransferase and urea nitrogen. Reversible pathological changes were also seen; hepatosplenomegaly, hepatocyte swelling and degeneration, splenic sinus expansion and congestion, renal tubular epithelial cells swelling and degeneration, and recovery was seen after 2 weeks of drug withdrawal. There is currently no research data on the genetic toxicity, reproductive toxicity and carcinogenicity of this product. In animal experiments, no reproductive toxicity was observed when piperacillin or sulbactam was used alone.

This product is a compound preparation, and its components are: each bottle contains 1.0g of piperacillin and 0.25g of sulbactam.

This product is white or off-white loose mass or powder, odorless, bitter and highly hygroscopic.

It is suitable for the following infections caused by β-lactamase-producing pathogens that are resistant to piperacillin but sensitive to this product. When used to treat mixed infections caused by bacteria that are sensitive to piperacillin alone and β-lactamase-producing bacteria that are resistant to piperacillin alone and sensitive to this product, no other antibiotics are needed. 1. Respiratory system infections: including acute bronchitis, acute exacerbation of chronic bronchitis, bronchiectasis complicated by infection, pneumonia and suppurative tonsillitis, etc. 2. Urinary system infections: including simple urinary system infections and complicated urinary system infections.

Usage: intravenous drip. Before use, dissolve each bottle of this product in an appropriate amount (see the table below) of 5% glucose injection and 0.9% sodium chloride injection, and then dilute it with the same solvent to 500-1000 ml for intravenous drip. The drip time is 30-60 minutes. Total dose (g) Total volume of piperacillin + sulbactam after water dissolution (ml) Maximum final concentration (mg/ml) 2.52.0+0.510200+50

Generally speaking, patients tolerate this product well, and only a few patients may experience it. 1. Gastrointestinal reactions: Like other antibiotics, the use of this product may cause diarrhea, loose stools, and occasionally nausea, vomiting, and flatulence. Pseudomembranous colitis is rare. 2. Skin reactions: Like penicillins and cephalosporins, this product can cause rash and itchy skin. 3. Allergic reactions: Like penicillins and cephalosporins, this product can cause allergic reactions. Therefore, you must ask about your allergy history before taking the drug. It is contraindicated for patients with a history of penicillin allergy. 4. Local reactions: Like other β-lactam antibiotics, this product can cause local irritation reactions, pain, phlebitis, thrombophlebitis, edema, etc. at the injection site. 5. Abnormal laboratory tests: Liver function: Transient increase in alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase. 6. Other reactions: Headache, dizziness, irritability, and anxiety can be seen.

It is contraindicated for patients who are allergic to penicillins, cephalosporins or β-lactamase inhibitors or have a history of allergy to the above drugs.

Precautions for children: There is no safety and efficacy data for this product for children. Precautions for pregnancy and lactation: A small amount of piperacillin can be excreted from breast milk, which can cause sensitization, diarrhea, Candida infection and rash in infants. A large amount of research data on the use of piperacillin sodium and sulbactam sodium for injection in pregnant and lactating women has not yet been obtained. Therefore, pregnant and lactating women should weigh the pros and cons when using this product. Precautions for the elderly: Elderly patients (>65 years old) may have slightly weakened renal function, so the dosage should be reduced as appropriate.

1. When this product is used in combination with probenecid, it can reduce the renal clearance of this product and prolong its half-life. 2. When this product is used simultaneously with tobramycin, it can reduce the area under the curve and renal clearance of tobramycin. 3. The activity of aminoglycoside antibiotics can be reduced due to the presence of penicillins. 4. When piperacillin is used simultaneously with the non-polar muscle relaxant vecuronium bromide, the neuromuscular blocking effect of vecuronium bromide can be prolonged. 5. When piperacillin is taken simultaneously with heparin, oral anticoagulants and other drugs that may affect the coagulation system and platelet function, coagulation indicators should be monitored regularly.

Sealed, store in a cool, dark (avoid light and not exceeding 20°C) dry place.

1.25g (including C23H27N5O7S1.0g and C8H11NO5S0.25g)

24 months

Sichuan Pharmaceutical, Inc.

• Founded in:

  2005-07-14

• Address:

  No. 18, Baiye Road, High-tech West District, Chengdu

• Tax NO.:

  91510100777457202W

• Registered Funds:

  80 million yuan

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