Piperacillin Sodium and Tazobactam Sodium for Injection

Piperacillin is a broad-spectrum semisynthetic penicillin that has a bactericidal effect by inhibiting the bacterial diaphragm and cell wall. Tazobactam, also known as triazinemethyl penicillin, is a strong inhibitor of multiple β-lactamases. β-lactamases include mediating enzymes on plasmids and chromosomes, which often cause bacterial resistance to penicillins and cephalosporins including third-generation cephalosporins. In the piperacillin/tazobactam formula, due to the presence of tazobactam, the antibacterial spectrum of piperacillin is enhanced and expanded, making it effective against β-lactamase-producing bacteria that were originally resistant to piperacillin and other β-lactam antibiotics, and possessing the dual characteristics of broad-spectrum antibiotics and β-lactamase inhibitors.

This product is a compound preparation, whose components are piperacillin sodium and tazobactam sodium (the labeled amount ratio of piperacillin and tazobactam is 8:1); the excipients are: disodium ethylenediaminetetraacetate (EDTA), citric acid, sodium bicarbonate and water for injection.

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

Tezhixing is indicated for the treatment of the following systemic and/or local bacterial infections caused by detected or suspected sensitive bacteria. 1. Lower respiratory tract infection. 2. Urinary tract infection (mixed infection or single bacterial infection). 3. Intra-abdominal infection. 4. Skin and soft tissue infection. 5. Bacterial sepsis. 6. Gynecological infection. 7. Used in combination with aminoglycosides for bacterial infections in patients with neutropenia. 8. Bone and joint infection. 9. Mixed infection with multiple bacteria; Tezhixing is indicated for the treatment of mixed infection with multiple bacteria, including infections with aerobic and anaerobic bacteria in suspected infection sites (intra-abdominal cavity, skin and soft tissue, upper and lower respiratory tract, gynecology). Although Tezhixing is only indicated for the above-mentioned situations, due to the presence of piperine in Tezhixing,

After fully dissolving the recommended dose 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, the recommended dose is 3.375g (containing 3g of piperacillin and 0.375g of tazobactam) intravenous drip 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 copper is not separated

Adverse reactions are listed in the table according to CIOMS frequency classification: Very common: ≥10% Common: ≥1% Uncommon: ≥0.1% and <1% Rare: ≥0.01% and <0.1% Very rare: <0.01% Body system adverse reactions Infections and infestations Uncommon: Candida superinfection Blood and lymphatic system disorders Uncommon: Leukopenia, neutropenia, thrombocytopenia Rare: Anemia, bleeding manifestations (including purpura, epistaxis, prolonged bleeding time), eosinophilia, hemolytic anemia Very rare: Agranulocytosis, positive Coombs direct test, pancytopenia, partial procoagulant

It is contraindicated in patients with hypersensitivity to any β-lactam antibiotics (including penicillins and 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. Tezhixing combined with gentamicin has no synergistic effect on Enterococcus faecalis. It can also have synergistic effects on certain sensitive strains of Escherichia coli, Pseudomonas aeruginosa, Klebsiella and Proteus in combination with certain cephalosporins. 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 tobramycin and piperacillin are used in combination. 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.

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

1.125g (containing piperacillin 1g, tazobactam 0.125g)

36 months

CSPC Zhongnuo PHARMACEUTICAL(Shijiazhuang) Co., Ltd.

• Founded in:

  1997-12-12

• Address:

  No. 88, Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei Province

• Tax NO.:

  91130100601908022F

• Registered Funds:

  678.5559 million yuan

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