Piperacillin Sodium Tazobactam Sodium
- product description
Bangda preparations (piperacillin sodium and tazobactam sodium preparations) consultation hotline: 0531-83126555
Generic name: Piperacillin Sodium Tazobactam Sodium for Injection
Commodity name: Bangda
English name: Piperacillin Sodium and Tazobactam Sodium for Injection
Chinese Pinyin: Zhusheyong Pailaxilinna Tazuobatanna
This product is a compound preparation, and its components are: piperacillin sodium and tazobactam sodium. 0.5625g each contains piperacillin 0.5g and tazobactam 62.5mg; 1.125g each contains piperacillin 1.0g and tazobactam 0.125g.
Molecular formula: C23H26N5NaO7S C10H11N4NaO5S
Molecular weight: 539.54 322.30
This product is white or almost white loose lumps or powder; odorless, bitter in taste, and highly hygroscopic.
This product is suitable for moderate and severe infections caused by β-lactamase-producing bacteria that are resistant to piperacillin but are sensitive to piperacillin/tazobactam:
1. Appendicitis (with perforation or abscess) caused by piperacillin-resistant, β-lactamase-producing Escherichia coli and Bacteroides (Bacteroides fragilis, Bacteroides ovatus, Bacteroides polymorpha, or Bacteroides vulgaris) ) And peritonitis.
2. Uncomplicated and complicated skin and soft tissue infections caused by piperacillin-resistant, β-lactamase-producing Staphylococcus aureus, including cellulitis, skin abscess, ischemic or diabetic foot infections.
3. Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β-lactamase-producing Escherichia coli bacteria.
4. Community-acquired pneumonia (moderate only) caused by piperacillin-resistant, β-lactamase-producing Haemophilus influenzae.
5. Moderate and severe hospital-acquired pneumonia (nosocomial pneumonia) caused by piperacillin-resistant and β-lactamase-producing Staphylococcus aureus. Treat systemic and (or) local bacterial infections caused by sensitive bacteria.
[Specifications] 0.5625g (containing piperacillin 0.5g, tazobactam 62.5mg); 1.125g (containing piperacillin 1.0g, tazobactam 0.125g)
Dissolve an appropriate amount of this product with 20 ml of diluent (0.9% sodium chloride injection or sterile water for injection), and immediately add it to 250 ml of liquid (5% glucose injection or 0.9% sodium chloride injection), intravenously Note, each time is at least 30 minutes, and the course of treatment is 7 to 10 days. The course of treatment for hospital-acquired pneumonia is 7 to 14 days. And can be adjusted according to the condition and bacteriological examination results.
For normal renal function (creatinine clearance rate>90ml/min) adults and children over 12 years old, 3.375g (including piperacillin 3g and tazobactam 0.375g) intravenous drip once every 6 hours. When treating hospital pneumonia, the starting dose is 3.375g once every 4 hours, and aminoglycoside drugs are combined at the same time; if Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued according to the degree of infection and condition drug.
For patients with renal insufficiency, the recommended dosage is shown in the table below:
For hemodialysis patients, the maximum dose per time is 2.25g, once every 8 hours, and 0.75g can be added after each hemodialysis.
1. Common adverse reactions of this product are:
(1) Skin reaction: skin rash, itching, etc.
(2) Gastrointestinal reactions: such as diarrhea, nausea, vomiting, etc.
(3) Allergic reaction.
(4) Local reactions: such as injection local irritation, pain, phlebitis, thrombophlebitis and edema.
(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.
2. In addition, the following adverse reactions can still be seen in this product:
(1) Diarrhea, constipation, nausea, vomiting, abdominal pain, indigestion, etc.
(2) Macular papules, herpes, urticaria, eczema, etc.
(3) Irritability, dizziness, anxiety, etc.
(4) Other reactions: such as rhinitis, dyspnea, etc.
People who are allergic to penicillins, cephalosporin antibiotics or β-lactamase inhibitors are prohibited.
1. Penicillin skin test must be done before medication, and those who are positive should not be allowed.
2. Cross-allergic reactions: Those who are allergic to cephalosporins, cephalosporins, griseofulvin or penicillamine can also be allergic to this product, and those who are allergic to one penicillin may also be allergic to other penicillins, so they are allergic to penicillin Those with history should avoid using this product.
3. People with history of allergies, bleeding, ulcerative colitis, localized enteritis or antibiotic-related enteritis should be used with caution; those with impaired renal function should be appropriately reduced. (See usage and dosage)
4. This product contains sodium, and patients who need to control salt intake should check their serum electrolyte levels regularly when using this product: For patients who are also treated with cytotoxic drugs or diuretics, be alert to the possibility of hypokalemia.
5. In patients with impaired renal function, the clotting time should be measured before or during the application period. Once bleeding occurs, it should be stopped.
6. Patients with pseudomembranous enteritis should undergo stool examination, culture of Clostridium difficile, and cytotoxic analysis of this bacteria.
7. Patients with liver and kidney dysfunction should monitor the concentration of piperacillin to adjust the dose.
8. Hematopoietic function should be checked regularly, especially for patients who have been treated for ≥21 days.
9. Existing clinical research data show that this product is not effective for lower respiratory tract infections and complicated urinary tract infections in hospitals.
10. Interference with diagnosis: Direct antiglobulin (Coombs) test may be positive during the application of this product, blood urea nitrogen and serum creatinine may also be increased, hypernatremia, hypokalemia, serum aminotransferase and serum lactic acid Increased dehydrogenase and increased serum bilirubin.
[Medication for pregnant women and lactating women]
Pregnant women use it with caution. A small amount of piperacillin can be excreted from breast milk, sensitizing the baby, causing diarrhea, candida infection and skin rash, so breastfeeding women should stop breastfeeding when using this product.
[Children's Medication] The safety and effectiveness of this product for children under 12 years of age are still unclear.
[Medication for the elderly] Elderly patients with decreased renal function, the dosage should be adjusted appropriately.
1. The combination of this product and gentamicin has no synergistic effect on Enterococcus faecalis. The combination with certain cephalosporins can also have a synergistic effect on some sensitive strains of Escherichia coli, Pseudomonas aeruginosa, Klebsiella and Proteus.
2. In in vitro tests, this product can be used in combination with aminoglycoside drugs to inactivate aminoglycoside drugs. When this product is used in combination with tobramycin, because piperacillin and tazobactam may inactivate tobramycin, the area under the curve of tobramycin, renal clearance and urinary excretion will decrease respectively. 11%, 32% and 38%. In patients with severe renal insufficiency, such as hemodialysis patients, when tobramycin and piperacillin are used in combination, the pharmacokinetics of the former will change.
3. The combination of this product and probenecid can prolong the half-life of piperacillin by 21% and the half-life of tazobactam by 71%.
4. Piperacillin, like carbenicillin, azlocillin, mezlocillin, and ticarcillin, may increase when combined with drugs that can produce hypothrombinism, thrombocytopenia, gastrointestinal ulcers or bleeding Impairment of blood coagulation mechanism and risk of 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 sulfopridone .
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. Do not mix with solutions containing only sodium bicarbonate, do not add blood products and hydrolyzed protein solutions.
As with other penicillin drugs, if the drug is administered intravenously and the dosage exceeds the recommended dose, the patient may experience neuromuscular excitement or convulsions.
[Pharmacology and Toxicology]
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 bacteria that produce β-lactamase resistant to piperacillin:
Gram-negative bacteria: most of the following bacteria that produce and do not produce β-lactamase that are plasmid-mediated: Escherichia coli, Klebsiella (Klebsiella oxytoca, Klebsiella pneumonia), Proteus Genus (Proteus mirabilis, Proteus vulgaris), Salmonella, Shigella, Neisseria gonorrhoeae, Neisseria meningitidis, Morgenella, Haemophilus (Influenza and Haemophilus parainfluenzae), Pasteurella multocida, Yersinia, Campylobacter, Gardnerella vaginalis. Chromosome-mediated β-lactamase-producing and non-producing the following bacteria: Citrobacter freudi, Citrobacter iso-citrate, Providencia, Morgenobacter, Serratia (Mycobacterium) Serratia marcescens, Serratia hydraulics), Pseudomonas aeruginosa and other Pseudomonas species (Pseudomonas cepacia, Pseudomonas fluorescens, Pseudomonas maltophilia), Acinetobacter species.
Gram-positive bacteria: the following bacteria that produce and do not produce β-lactamase: Streptococcus (Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus bovis, Streptococcus agalactiae, Streptococcus viridans, C and G chain Cocci), Enterococcus (Enterococcus faecalis, Enterococcus faecium), Staphylococcus aureus (excluding MRSA), Staphylococcus saprophyticus, Staphylococcus epidermidis (coagulase-negative Staphylococcus), Corynebacterium, mononucleosis Listeria, Nocardia.
Anaerobic bacteria: the following bacteria that produce and do not produce β-lactamases: Bacteroides (Bacteroides diluvialis, Bacteroides bidirectional, Bacteroides polychaetus, Bacteroides melaninogens, Bacteroides fragile), Bacteroides fragilis ( Bacteroides fragilis, Bacteroides vulgaris, Bacteroides ovalifolia, Bacteroides polymorpha, Bacteroides monomorphs, Bacteroides saccharosolvus), Peptostreptococcus, Clostridium spp (Clostridium difficile, Air-producing capsules) Bacillus), Veillonella, Actinomycetes.
After intravenous infusion of this product, the concentrations of piperacillin and tazobactam in the plasma quickly reach the peak. After 30 minutes of instillation, the plasma concentration of piperacillin was equal to the plasma concentration of the same dose of piperacillin. At 30 minutes after intravenous infusion of 2.25g, 3.375g and 4.5g piperacillin sodium and tazobactam sodium, the plasma piperacillin The peak concentrations of cilin (Cmax) were 134, 242, and 298 mg/L, respectively, and the peak concentrations (Cmax) of tazobactam were 15, 24, and 34 mg/L, respectively.
After healthy subjects receive a single or multiple doses of piperacillin sodium and tazobactam sodium, the blood elimination half-life (t1/2) of piperacillin and tazobactam ranges from 0.7 to 1.2 hours. The effect of medication time. Piperacillin is metabolized in the body into tiny biologically active deethyl metabolites, tazobactam is metabolized into products without pharmacological and antibacterial activity, and both piperacillin and tazobactam are excreted by the kidneys. 68% of piperacillin is rapidly excreted in the urine in its original form; tazobactam and its metabolites are mainly excreted through the kidneys, of which 80% are in its original form. Piperacillin, tazobactam, and desethylpiperacillin can also be secreted by bile. About 30% of piperacillin and tazobactam are bound to plasma proteins, and their binding rate is not affected by other compounds; the binding of plasma proteins to tazobactam metabolites is negligible.
Piperacillin and tazobactam are widely distributed in tissues and body fluids, including gastrointestinal mucosa, gallbladder, lungs, female reproductive organs (uterus, ovaries, fallopian tubes), body fluids, and bile. The concentration of the drug in the tissue is about 50% to 100% of the plasma concentration. Like other penicillins, when the meninges are non-inflammatory, the concentration of piperacillin and tazobactam in the cerebrospinal fluid is very low. The blood elimination half-life of piperacillin and tazobactam in patients with renal impairment increases with the decrease of creatinine clearance. When the creatinine clearance rate is less than 20ml/min, the blood elimination half-life of piperacillin is twice that of normal people, and the blood elimination half-life of tazobactam is 4 times that of normal people.
Hemodialysis can remove 30%-40% of piperacillin and tazobactam, and the other 5% of tazobactam is removed by dialysis as metabolites. Peritoneal dialysis can remove 6% piperacillin and 21% of tazobactam, and up to 16% of tazobactam is removed as metabolites. Compared with normal people, the blood elimination half-lives of piperacillin and tazobactam in patients with liver cirrhosis are extended by 25% and 18%, respectively, but there is no need to adjust the dose.
[Storage] Shading, airtight, and storing in a cool, dark (no more than 20°C) and dry place.
[Packing] Glass bottle packaging, 5 pcs/box.
[Validity] 24 months.
[Executive Standard] The first supplement to the 2010 edition of the Chinese Pharmacopoeia
[Approval Number] National Medicine Standard H19990181; National Medicine Standard H19990182
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