Ceftazidime/Avibactam Pfizer

Menu

Close

HomeAboutAbout Ceftazidime/avibactam PfizerPatient ProfilesIDSA guidelinesEfficacySafetyImportant Safety InformationSafety DataDosingMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

To report an adverse event, please contact [email protected]

Safety and Tolerability​​​​​​​Ceftazidime/Avibactam Pfizer (ceftazidime and avibactam) has a safety and tolerability profile consistent with both cephalosporins and carbapenems1–4In four Phase III clinical trials, the adverse-event profile of Ceftazidime/Avibactam Pfizer was similar to that seen with either best available therapy, doripenem or meropenem1–4Ceftazidime/Avibactam Pfizer has no requirement for routine monitoring and a low potential for drug–drug interactions1

Ceftazidime/Avibactam Pfizer In vitro drug combination studies with Ceftazidime/Avibactam Pfizer have demonstrated neither synergy nor antagonism with the following drugs: metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline.

Interaction with other antimicrobial agents: Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo, this drug combination should be avoided.

Interaction with other medicinal products and other forms of interaction: In vitro, probenecid, a potent OAT inhibitor, inhibits avibactam uptake by 56–70%, potentially altering the elimination of avibactam. Since a clinical interaction trial of avibactam and probenecid has not been conducted, co-administration is not recommended. Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro. Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations. Avibactam and ceftazidime do not inhibit the major renal or hepatic transporters in the clinically relevant exposure range, therefore the interaction potential via these mechanisms is considered low.
Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam, and between Ceftazidime/Avibactam Pfizer and metronidazole.
Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products, such as aminoglycosides or potent diuretics (e.g. furosemide), may adversely affect renal function.

Ceftazidime/Avibactam Pfizer has the following contraindications:5
  • Hypersensitivity to the active substances or to any of the excipients
  • Hypersensitivity to any cephalosporin antibacterial agent
  • Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g., penicillins, monobactams or carbapenems)
Ceftazidime/Avibactam Pfizer has some special warnings and precautions for use5

Hypersensitivity reactions
Serious and occasionally fatal hypersensitivity reactions are possible. In case of hypersensitivity reactions, treatment with Ceftazidime/Avibactam Pfizer must be discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam antibacterial agent. Caution should be used if ceftazidime and avibactam is given to patients with a history of non-severe hypersensitivity to penicillins, monobactams or carbapenems.

Clostridium difficile-associated diarrhoea
Clostridium difficile-associated diarrhoea has been reported with ceftazidime and avibactam, and can range in severity from mild to life-threatening. This diagnosis should be considered in patients who present with diarrhoea during or subsequent to the administration of Ceftazidime/Avibactam Pfizer. Discontinuation of therapy with Ceftazidime/Avibactam Pfizer and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

*Based on data from seven Phase II and Phase III clinical trials in 2024 adult patients treated with Ceftazidime/Avibactam Pfizer.5

AE, adverse event; DDI, drug-drug interaction; DAGT, direct antiglobulin test; IDSA, Infectious Diseases Society of America; OAT, organic anion transporter.
References :1. Carmeli Y, Armstrong J, Laud PJ, et al. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016;16:661–673 2. Mazuski JE, Gasink LB, Armstrong J, et al. Efficacy and Safety of Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection: Results From a Randomized, Controlled, Double-Blind, Phase 3 Program. Clin Infect Dis. 2016;62:1380–1389. 3. Wagenlehner FM, Sobel JD, Newell P, et al. Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program. Clin Infect Dis. 2016;63:754–762. 4. Torres A, Zhong N, Pach J, et al. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018;18:285–295. 5. Ceftazidime/Avibactam Pfizer [SmPC], Pfizer
Explore more Clinical efficacy Learn More Loading

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

This site is intended only for Rwanda health care professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2022 Pfizer Inc. All rights reserved.

Disclaimer: The product is not yet licensed by the Board of Health of Rwanda (Rwanda FDA). The product has however obtained prior Board of Health approval for supply to Accord program channels in Rwanda.

You are now leaving Accord Portal to access Pfizer Medical Information Portal  You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.