Piperacillin Sodium and Tazobactam Sodium for Injection

Piperacillin is a semi-synthetic penicillin antibiotic, and tazobactam is a β-lactamase inhibitor. This product has antibacterial effects on piperacillin-sensitive bacteria and the following β-lactamase-producing bacteria that are resistant to piperacillin: Gram-negative bacteria: most of the following plasmid-mediated β-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 Haemophilus parainfluenzae), Pasteurella multocida, Yersinia, Campylobacter, and Gardnerella vaginalis. The following chromosome-mediated β-lactamase-producing and non-producing bacteria: Citrobacter freundii, Isocitrate bacteria, Pruvidin

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

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. Treatment of systemic and/or local bacterial infections caused by sensitive bacteria.

After fully dissolving an appropriate amount of this product with 20 ml of diluent (sodium chloride injection or sterile water for injection), immediately add it to 250 ml of liquid (5% glucose injection or sodium chloride injection) and drip 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 the results of bacteriological examinations. For adults with normal renal function (creatinine clearance > 90 ml/min) and children over 12 years old, 3.375 g (containing 3 g of piperacillin and 0.375 g of tazobactam) is intravenously dripped once every 6 hours. When treating hospital-acquired pneumonia, the starting dose is 3.375 g once, once every 4 hours, and aminoglycosides are used in combination; if Pseudomonas aeruginosa is not isolated, it can be used.

1. Common adverse reactions of this product include: (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) Others

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

Precautions for children: The safety and effectiveness of this product for children under 12 years old is still unclear. Precautions for pregnancy and lactation: Use with caution in pregnant women. A small amount of piperacillin can be excreted from breast milk, causing sensitization in infants, diarrhea, candidal infection and rash, so breastfeeding should be suspended when using this product. Precautions for the elderly: Elderly patients have impaired renal function and the dosage should be adjusted appropriately.

1. This product has no synergistic effect with gentamicin against Enterococcus faecalis. It can also produce synergistic effects with certain cephalosporins against certain 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% when used in combination with probenecid.

Protect from light, seal tightly, and store in a dry and cool place.

4.5 g (piperacillin 4.0 g and tazobactam 0.5 g)