Piperacillin Sodium and Tazobactam Sodium for Injection

Piperacillin is a semi-synthetic penicillin antibiotic, and tazobactam is a beta-lactamase inhibitor. This product has antibacterial effects on piperacillin-sensitive bacteria and the following bacteria that produce beta-lactamase and are resistant to piperacillin: Gram-negative bacteria: most plasmid-induced beta-lactamase-producing and non-producing bacteria: Escherichia coli, Klebsiella (Klebsiella oxytoca, Klebsiella pneumoniae), Proteus (Proteus mirabilis, Proteus vulgaris), Salmonella, Shigella, Neisseria gonorrhoeae, Neisseria meningitidis, Mongenobacter, Haemophilus (Haemophilus influenzae and parainfluenzae), Pasteurella multocida, Yersinia, Campylobacter, and Gardnerella vaginalis. Chromosome-induced beta-lactamase-producing and non-producing bacteria: Citrobacter freundii, isocitrifying bacteria, Providencia, Morgenbacterium, Serratia (Serratia marcescens, Serratia hydraulica), Pseudomonas aeruginosa and other Pseudomonas (Pseudomonas cepacia, Pseudomonas fluorescens, Pseudomonas maltophilia), Acinetobacter. Gram-positive bacteria: the following bacteria that produce and do not produce beta-lactamase: Streptococcus (Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus bovis, Streptococcus agalactiae, Streptococcus viridans, Group C and Group G Streptococci), Enterococcus (Enterococcus faecalis, Enterococcus faecium), Staphylococcus aureus (excluding MRSA), Staphylococcus saprophyticus, Staphylococcus epidermidis (coagulase-negative staphylococci), Corynebacterium, Listeria monocytogenes, Nocardia. Anaerobic bacteria: The following bacteria that produce and do not produce beta-lactamases: Bacteroides, Bacteroides fragilis, Peptostreptococcus, Clostridium (C. difficile, Clostridium perfringens), Veillonella, and Actinomyces.

This product is a compound preparation, whose components are sterile powders uniformly mixed with piperacillin sodium and tazobactam sodium (the labeled ratio of piperacillin (C23H27N5O7S) to tazobactam (C10H12N4O5S) is 8:1).

This product is suitable for moderate and severe infections caused by β-lactamase-producing bacteria that are resistant to piperacillin but sensitive to piperacillin-tazobactam. 1. Appendicitis (with perforation or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase-producing Escherichia coli and Bacteroides (Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron or Bacteroides vulgaris). 2. Uncomplicated and complicated skin and soft tissue infections caused by piperacillin-resistant, β-lactamase-producing Staphylococcus aureus, including cellulitis, skin abscesses, ischemic or diabetic foot infections. 3. Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β-lactamase-producing Escherichia coli. 4. Community-acquired pneumonia (moderate only) caused by piperacillin-resistant, β-lactamase-producing Haemophilus influenzae. 5. Moderate to severe hospital-acquired pneumonia (hospital pneumonia) caused by piperacillin-resistant, β-lactamase-producing Staphylococcus aureus. Treat systemic and/or local bacterial infections caused by sensitive bacteria.

After fully dissolving an appropriate amount of this product with 20ml of diluent (sodium chloride injection or sterile water for injection), immediately add it to 250ml of liquid (5% glucose injection or sodium chloride injection) and drip it intravenously for at least 30 minutes each time. The course of treatment is 7 to 10 days. The course of treatment for hospital-acquired pneumonia is 7 to 14 days. It can be adjusted according to the condition and bacteriological examination results. For adults with normal renal function (creatinine clearance 90ml/minute) and children over 12 years old, 3.375g (containing piperacillin 3g and tazobactam 0.375g) is dripped intravenously once every 6 hours. When treating hospital-acquired pneumonia, the starting dose is 3.375g once, once every 4 hours, and aminoglycosides are used in combination; if Pseudomonas aeruginosa is not isolated, aminoglycosides can be considered to be discontinued according to the degree of infection and condition. For patients with renal insufficiency, the recommended dosage is shown in the table below: Creatinine clearance (ml/min) Recommended dosage 40-90 3.375g once, once every 6 hours, total daily amount 12g/1.5g 20-40 2.25g once, once every 6 hours, total daily amount 8g/1.0g<20 2.25g once, once every 8 hours, total daily amount 6g/0.75g For patients on hemodialysis, the maximum dose is 2.25g once, once every 8 hours, and an additional 0.75g can be added after each hemodialysis.

1. Common adverse reactions of this product (1) Skin reactions: rash, itching, etc. (2) Gastrointestinal reactions: such as diarrhea, nausea, vomiting, etc. (3) Allergic reactions. (4) Local reactions: such as local irritation reaction after injection, pain, phlebitis, thrombophlebitis and edema, etc. (5) Other reactions: such as thrombocytopenia, pancreatitis, fever, fever with eosinophilia, elevated serum aminotransferase, etc.; these reactions occur when this product is combined with aminoglycoside drugs for treatment. 2. In addition, the following adverse reactions may also be seen with this product. (1) Diarrhea, constipation, nausea, vomiting, abdominal pain, indigestion, etc. (2) Maculopapular rash, herpes, urticaria, eczema, etc. (3) Irritability, dizziness, anxiety, etc. (4) Other reactions: such as rhinitis, dyspnea, etc.

It is contraindicated for patients who are allergic to penicillins, cephalosporins or beta-lactamase inhibitors.

1. This product has no synergistic effect with gentamicin against Enterococcus faecalis. It can also have synergistic effect with some cephalosporins against some sensitive strains of Escherichia coli, Pseudomonas aeruginosa, Klebsiella and Proteus. 2. In in vitro tests, this product can inactivate aminoglycosides when used in combination with aminoglycosides. When this product is used in combination with tobramycin, the area under the drug-time curve, renal clearance and urinary excretion of tobramycin will decrease by 11%, 32% and 38% respectively, because piperacillin-tazobactam may inactivate tobramycin. In patients with severe renal insufficiency, such as hemodialysis patients, the pharmacokinetics of tobramycin will change when it is used in combination with piperacillin. 3. This product can prolong the half-life of piperacillin by 21% and the half-life of tazobactam by 71% when used in combination with probenecid. 4. Piperacillin, like carbenicillin, azlocillin, mezlocillin, and ticarcillin, may increase the risk of coagulation disorders and bleeding when used in combination with drugs that can cause hypoprothrombinemia, thrombocytopenia, gastrointestinal ulcers or bleeding. Such as anticoagulants: heparin, coumarin, indandione; non-steroidal anti-inflammatory analgesics, especially aspirin, diflunisal and other salicylic acid preparations, other platelet aggregation inhibitors or sulfinpyrazone. 5. This product cannot be mixed with other drugs in a syringe or infusion bottle. When used with other antibiotics, they must be administered separately. It must not be mixed with solutions containing sodium bicarbonate, and blood products must not be added.

Keep away from light, seal tightly, and store in a cool, dark and dry place (not exceeding 20℃).

4.5g (C23H27N5O7S4.0g and C10H12N4O5S0.5g)

Xiangbei Welman Pharmaceutical Co., Ltd.

• Founded in:

  1995-09-26

• Address:

  Dongyang Township, Liuyang City, Hunan Province (inside the Biomedical Park)

• Tax NO.:

  914301006166609551

• Registered Funds:

  365.925 million yuan

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