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Tazobactam | CAS No: 89786-04-9 | GMP-certified suppliers
A medication that extends the antibacterial spectrum of beta-lactam antibiotics to treat complicated skin, intra-abdominal, urinary tract, and hospital-acquired bacterial infections.
Therapeutic categories
AmidesAnti-Infective AgentsAntibacterials for Systemic UseAntiinfectives for Systemic UseAza CompoundsAzabicyclo Compounds
Generic name
Tazobactam
Molecule type
small molecule
CAS number
89786-04-9
DrugBank ID
DB01606
Approval status
Approved drug
ATC code
J01CG02
Primary indications
- Tazobactam is used in combination with piperacillin or ceftolozane to broaden the spectrum of piperacillin antibacterial action, treating susceptible infections
- As with any other antibiotic, tazobactam should only be used for infections that are either proven or strongly suspected to be susceptible to the tazobactam containing drug
- Tazobactam-piperacillin**
- When combined with piperacillin, it is used to treat a variety of infections, including those caused by aerobic and facultative gram-positive and gram-negative bacteria, in addition to gram-positive and gram-negative anaerobes
Product Snapshot
- Tazobactam is formulated as an injectable beta-lactamase inhibitor, supplied as powder or solution for parenteral administration
- It is primarily used in combination with piperacillin or ceftolozane to treat various bacterial infections, including complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia
- Tazobactam-containing formulations are approved for use in key regulatory markets including the US, EU, and Canada
Clinical Overview
Tazobactam is a beta-lactamase inhibitor used in combination with beta-lactam antibiotics such as piperacillin and ceftolozane to treat bacterial infections caused by beta-lactamase producing organisms. It does not possess significant intrinsic antibacterial activity but serves to protect its antibiotic partner from enzymatic degradation, thereby extending the spectrum of antibacterial coverage.
Clinically, tazobactam is combined with piperacillin to treat infections caused by both gram-positive and gram-negative aerobic and anaerobic bacteria. Indications include complicated skin and soft tissue infections (such as cellulitis), diabetic foot infections, intra-abdominal infections including appendicitis, and postpartum endometritis. Additionally, tazobactam combined with ceftolozane is approved for complicated intra-abdominal infections (in combination with metronidazole), complicated urinary tract infections including pyelonephritis, and hospital-acquired and ventilator-associated bacterial pneumonia. The latter indication addresses serious nosocomial infections with significant associated morbidity.
Pharmacodynamically, tazobactam irreversibly inhibits serine beta-lactamase enzymes, including TEM, SHV, and OHIO-1 groups, which are commonly responsible for bacterial resistance to beta-lactam antibiotics. By covalently binding to beta-lactamase enzymes, it prevents degradation of the beta-lactam ring in piperacillin or ceftolozane, allowing these antibiotics to maintain their bactericidal activity. Tazobactam demonstrates activity mainly against beta-lactamases from plasmid and chromosomal origins but is inactive against certain mutant enzymes conferring extended-spectrum beta-lactamase (ESBL) resistance.
Pharmacokinetic parameters of tazobactam include good systemic absorption when administered intravenously as a fixed-dose combination. It undergoes renal elimination, and considerations regarding dosage adjustments in renal impairment are applicable. Metabolism is limited, and it does not exhibit significant cytochrome P450 interactions.
Safety profiles of tazobactam-containing combinations are consistent with beta-lactam antibiotics, including hypersensitivity reactions, gastrointestinal disturbances, and risks of superinfection. Resistance can emerge via beta-lactamase variants or other mechanisms; therefore, antimicrobial susceptibility testing is recommended to guide appropriate use.
Notable brands include Zosyn (piperacillin-tazobactam) and Zerbaxa (ceftolozane-tazobactam), approved by the U.S. FDA since 1994 and 2014 respectively, and used worldwide in hospital settings for serious infections.
From a sourcing and quality perspective, pharmaceutical-grade tazobactam APIs must meet stringent purity specifications to ensure potency and minimize impurities that could affect stability or safety. Stability under recommended storage, compliance with pharmacopeial standards, and reliable supply chain traceability are critical. Suppliers should provide comprehensive documentation including certificates of analysis and comply with current good manufacturing practices (cGMP) to support regulatory submissions and quality assurance protocols.
Clinically, tazobactam is combined with piperacillin to treat infections caused by both gram-positive and gram-negative aerobic and anaerobic bacteria. Indications include complicated skin and soft tissue infections (such as cellulitis), diabetic foot infections, intra-abdominal infections including appendicitis, and postpartum endometritis. Additionally, tazobactam combined with ceftolozane is approved for complicated intra-abdominal infections (in combination with metronidazole), complicated urinary tract infections including pyelonephritis, and hospital-acquired and ventilator-associated bacterial pneumonia. The latter indication addresses serious nosocomial infections with significant associated morbidity.
Pharmacodynamically, tazobactam irreversibly inhibits serine beta-lactamase enzymes, including TEM, SHV, and OHIO-1 groups, which are commonly responsible for bacterial resistance to beta-lactam antibiotics. By covalently binding to beta-lactamase enzymes, it prevents degradation of the beta-lactam ring in piperacillin or ceftolozane, allowing these antibiotics to maintain their bactericidal activity. Tazobactam demonstrates activity mainly against beta-lactamases from plasmid and chromosomal origins but is inactive against certain mutant enzymes conferring extended-spectrum beta-lactamase (ESBL) resistance.
Pharmacokinetic parameters of tazobactam include good systemic absorption when administered intravenously as a fixed-dose combination. It undergoes renal elimination, and considerations regarding dosage adjustments in renal impairment are applicable. Metabolism is limited, and it does not exhibit significant cytochrome P450 interactions.
Safety profiles of tazobactam-containing combinations are consistent with beta-lactam antibiotics, including hypersensitivity reactions, gastrointestinal disturbances, and risks of superinfection. Resistance can emerge via beta-lactamase variants or other mechanisms; therefore, antimicrobial susceptibility testing is recommended to guide appropriate use.
Notable brands include Zosyn (piperacillin-tazobactam) and Zerbaxa (ceftolozane-tazobactam), approved by the U.S. FDA since 1994 and 2014 respectively, and used worldwide in hospital settings for serious infections.
From a sourcing and quality perspective, pharmaceutical-grade tazobactam APIs must meet stringent purity specifications to ensure potency and minimize impurities that could affect stability or safety. Stability under recommended storage, compliance with pharmacopeial standards, and reliable supply chain traceability are critical. Suppliers should provide comprehensive documentation including certificates of analysis and comply with current good manufacturing practices (cGMP) to support regulatory submissions and quality assurance protocols.
Identification & chemistry
| Generic name | Tazobactam |
|---|---|
| Molecule type | Small molecule |
| CAS | 89786-04-9 |
| UNII | SE10G96M8W |
| DrugBank ID | DB01606 |
Pharmacology
| Summary | Tazobactam is a beta-lactamase inhibitor that irreversibly binds and inactivates plasmid- and chromosome-mediated beta-lactamase enzymes, including TEM, SHV-1, and Ohio-1 groups. It enhances the antibacterial spectrum of beta-lactam antibiotics such as piperacillin and ceftolozane by protecting them from enzymatic degradation by resistant bacteria. Tazobactam exhibits minimal intrinsic antibacterial activity and is primarily used in combination therapies to treat infections caused by beta-lactamase-producing organisms. |
|---|---|
| Mechanism of action | Tazobactam broadens the spectrum of piperacillin and ceftolozane by making them effective against organisms that express beta-lactamase and would normally degrade them. This occurs through the irreversible inhibition of beta-lactamase enzymes. In addition, tazobactam may bind covalently to plasmid-mediated and chromosome-mediated beta-lactamase enzymes. Tazobactam is predominantly effective against the OHIO-1, SHV-1, and TEM groups of beta-lactamases, but may also inhibit other beta-lactamases. Tazobactam shows little antibacterial activity by itself, and for this reason, is generally not administered alone. |
| Pharmacodynamics | Tazobactam inhibits the action of bacterial beta-lactamase producing organisms, which are normally resistant to beta-lactam antibiotics. This augments the effects of antibiotics which would otherwise not be effective in treating certain infections. These antibiotics contain a beta-lactam ring in their chemical structure, which is destroyed by beta-lactam resistant organisms. When combined with other antibiotics, a variety of infections, including serious and life-threatening infections may be treated. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Beta-lactamase TEM | Salmonella typhi | inhibitor |
| Beta-lactamase Ohio-1 | Enterobacter cloacae | inhibitor |
| Beta-lactamase SHV-1 | Escherichia coli | inhibitor |
ADME / PK
| Absorption | Tazobactam is coadministered with piperacillin or ceftolozane, pharmacokinetic information will be provided for these combinations. **Piperacillin-tazobactam** Peak plasma concentrations occur immediately after the completion of intravenous infusion. Following several doses of piperacillin-tazobactam infusions every 6 hours, peak concentrations were similar to those that were measured after the initial dose. **Ceftolozane-piperacillin** AUC: 24.4-25 mcg•h/mL Peak concentrations are reached on day 1 after the first dose and range from 18 to 18.4 mcg/mL. |
|---|---|
| Half-life | Piperacillin-tazobactam After a single dose in healthy volunteers, the plasma half-life of piperacillin and tazobactam was in the range of 0.7 to 1.2 hours. Ceftolozane-tazobactam 0.91-1.03 hours |
| Protein binding | Tazobactam is bout 30% bound to plasma proteins. |
| Metabolism | Tazobactam is mainly metabolized to M1, an inactive metabolite. Hydrolysis occurs on the beta-lactam ring to form M1 (the inactive metabolite). |
| Route of elimination | Tazobactam and its metabolite are mainly eliminated by the kidneys with about 80% of the administered dose eliminated as unchanged drug. The remaining drug is excreted as a single metabolite. |
| Volume of distribution | 18.2 L when given with piperacillin 13.5-18.2 L when given with ceftolozane Piperacillin-tazobactam is widely distributed in body tissues and fluids. These may include but are not limited to the intestine, gallbladder, lung, female reproductive organs, and the bile. Meningeal distribution of piperacillin-tazobactam increases with inflammation, but is otherwise low. |
| Clearance | Because tazobactam is cleared by the kidneys and is a substrate of the transporters OAT1 and OAT3, inhibitors of these transporters should be avoided to ensure efficacy. Dosage adjustments of piperacillin-tazobactam and ceftolozane-tazobactam must be made for patients with impaired renal clearance. The mean clearance rate of tazobactam was found to be 48.3-83.6 mL/min in patients admitted to the intensive care unit who were given renal replacement therapy and receiving intravenous piperacillin-tazobactam. The clearance of tazobactam is dependent on renal function, as determined by renal clearance.[FDA label,A179377] |
Formulation & handling
- Tazobactam is a small molecule alpha amino acid derivative predominantly administered via intravenous and intramuscular injection.
- The compound is formulated as powders for reconstitution, including lyophilized forms, indicating sensitivity that may require careful handling to maintain stability.
- Its high water solubility and low logP suggest good aqueous compatibility, but formulation should consider solution stability and sterility for parenteral use.
Regulatory status
| Lifecycle | The API is in the mature phase of its lifecycle, with primary patent protections having expired between 2019 and 2024 in the United States. It is marketed in Canada, the US, and the EU, where generic competition is likely established. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | The Tazobactam supply landscape involves multiple packagers active in key markets including Canada, the US, and the EU. Branded products are widely available under various Piperacillin/Tazobactam formulations across these regions. Recent patent expirations and those approaching in the US indicate the presence of existing generic competition as well as potential for new entrants. |
|---|
Safety
| Toxicity | **Overdose** Post-marketing reports have been made of overdose cases with piperacillin/tazobactam. Nausea, vomiting, and diarrhea are frequent manifestations of an overdose. Neuromuscular excitability or seizures may also occur with high intravenous doses or renal failure. There is no specific antidote. Provide supportive measures in case of an overdose. Anticonvulsive agents may be indicated when neuromuscular excitability or seizures occur. If anaphylaxis occurs, traditional measures should be taken to manage hypersensitivity (for example, adrenaline, antihistamines, corticosteroids, and oxygen/airway maintenance). Similar measures should be taken after a ceftolozane-tazobactam overdose. Hemodialysis can be used to remove the drug from the circulation [FDA label,L4417]. **A note on nephrotoxicity** Cases of life-threatening nephrotoxicity have been seen in critically ill patients receiving piperacillin-tazobactam. Alternative therapy and/or renal monitoring should be considered in critically ill patients. **Carcinogenesis/Mutagenesis** Tazobactam tested negative for genotoxic effects in the Ames assay, an after in vitro chromosomal aberration and point mutation assay in the Chinese hamster, an various other assays. **Use in pregnancy** Tazobactam has been found cross the placenta in rats. No data on human studies are available, however, rat studies have shown no teratogenetic effects at doses 6-14 times the equivalent maximum recommended human dose. **Use in lactation** There are no data on the presence of tazobactam in human breastmilk. No data are currently available on the effects of tazobactam on the infant, or how it affects milk production. Use clinical judgement and consider the maternal need for the drug and the benefits of breastfeeding the infant before administration during lactation. Small concentrations of piperacillin-tazobactam have been found in the breastmilk and can lead to hypersensitivity in a breastfeeding infant. In some cases, breastfeeding may have to be discontinued temporarily. |
|---|
High Level Warnings:
- Overdose cases may result in gastrointestinal symptoms (nausea, vomiting, diarrhea) and central nervous system excitability, including seizures, particularly with high intravenous doses or impaired renal function
- Life-threatening nephrotoxicity has been reported in critically ill patients
- Renal function monitoring is recommended during treatment
Tazobactam is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Tazobactam API manufacturers & distributors
Compare qualified Tazobactam API suppliers worldwide. We currently have 5 companies offering Tazobactam API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, WC | 250 products |
| Otsuka Chemical | Producer | Japan | Japan | CoA, JDMF, USDMF | 1 products |
| Qilu Tianhe | Producer | China | China | CoA, JDMF, USDMF, WC | 16 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS | 757 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF, WC | 69 products |
When sending a request, specify which Tazobactam API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Tazobactam API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
