Aztreonam-avibactam renal dosing is based on estimated creatinine clearance (CrCl). As renal function declines, the loading dose, maintenance dose, and dosing interval may need to change.
Current U.S. prescribing information uses Cockcroft-Gault estimated CrCl to determine the renal dosing category. European product information also uses Cockcroft-Gault for its renal dosing recommendations.
Because the U.S. and European product information should not be treated as one universal dosing framework, the tables below are presented separately.
Educational information only: Dosing of aztreonam-avibactam should be determined using the applicable current prescribing information and the patient’s clinical condition, renal function, and treatment setting. This article does not replace advice from a qualified healthcare professional.
Aztreonam Avibactam Renal Dosing at a Glance
The labeled renal-dosing approach can be understood through five steps:
Creatinine clearance → renal category → loading dose → maintenance dose → dosing interval
For adults, the current U.S. labeling provides different regimens for:
- CrCl >50 mL/min
- CrCl >30 to ≤50 mL/min
- CrCl >15 to ≤30 mL/min
- CrCl ≤15 mL/min, including patients receiving hemodialysis
The U.S. label also states that creatinine clearance should be monitored in patients whose renal function is changing, with dose adjustment as appropriate.
How Is Creatinine Clearance Used for Aztreonam Avibactam Dosing?
Cockcroft-Gault and labeled CrCl
The current U.S. and European product information specifies estimated creatinine clearance calculated using the Cockcroft-Gault formula for renal-dose assessment.
Therefore, the renal-dosing tables should not simply be interpreted as generic eGFR-based recommendations.
The relevant question is not only whether a patient has “kidney impairment,” but which estimated CrCl category applies under the applicable prescribing information.
Why changing renal function matters
Renal function can change during treatment, particularly in patients with acute illness.
The current U.S. label specifically recommends monitoring creatinine clearance in patients with changing renal function and adjusting the dose accordingly.
This means a renal-dose category should not necessarily be treated as permanently fixed throughout treatment when kidney function is changing.
U.S. Aztreonam Avibactam Renal Dosing
The current U.S. EMBLAVEO prescribing information, updated June 24, 2026, provides the following renal dosing table.
U.S. FDA/DailyMed renal dosing
| Estimated CrCl | Loading dose | Maintenance dose | Interval | Infusion |
|---|---|---|---|---|
| >50 mL/min | 2.67 g = 2 g aztreonam + 0.67 g avibactam | 2 g = 1.5 g + 0.5 g | Every 6 hours | 3 hours |
| >30 to ≤50 mL/min | 2.67 g = 2 g + 0.67 g | 1 g = 0.75 g + 0.25 g | Every 6 hours | 3 hours |
| >15 to ≤30 mL/min | 1.8 g = 1.35 g + 0.45 g | 0.9 g = 0.675 g + 0.225 g | Every 8 hours | 3 hours |
| ≤15 mL/min, including HD | 1.33 g = 1 g + 0.33 g | 0.9 g = 0.675 g + 0.225 g | Every 12 hours | 3 hours |
The U.S. labeling specifies that a single loading dose is followed by maintenance dosing beginning at the next dosing interval. The dosing interval is measured from the start of one infusion to the start of the next infusion.
Source: Current U.S. EMBLAVEO prescribing information/DailyMed, June 24, 2026.
CrCl >50 mL/min
For patients with estimated CrCl above 50 mL/min, the U.S. labeled regimen is:
- Loading dose: 2.67 g
- Maintenance dose: 2 g
- Interval: every 6 hours
- Infusion: 3 hours
The 2 g maintenance dose contains:
- 1.5 g aztreonam
- 0.5 g avibactam
This is the standard renal category in the U.S. dosing table.
CrCl >30 to ≤50 mL/min
When estimated CrCl falls into the >30 to ≤50 mL/min category, the U.S. maintenance dose is reduced.
The labeled regimen is:
- Loading dose: 2.67 g
- Maintenance dose: 1 g
- Interval: every 6 hours
- Infusion: 3 hours
The 1 g maintenance dose consists of:
- 0.75 g aztreonam
- 0.25 g avibactam
Importantly, the loading dose remains 2.67 g in this category under the U.S. table.
CrCl >15 to ≤30 mL/min
For estimated CrCl above 15 and up to 30 mL/min, both the dose and interval change.
The U.S. labeled regimen is:
- Loading dose: 1.8 g
- Maintenance dose: 0.9 g
- Interval: every 8 hours
- Infusion: 3 hours
The 0.9 g maintenance dose contains:
- 0.675 g aztreonam
- 0.225 g avibactam
CrCl ≤15 mL/min
For estimated CrCl of 15 mL/min or less, including patients receiving hemodialysis, the U.S. table specifies:
- Loading dose: 1.33 g
- Maintenance dose: 0.9 g
- Interval: every 12 hours
- Infusion: 3 hours
The maintenance dose contains:
- 0.675 g aztreonam
- 0.225 g avibactam
Patients receiving hemodialysis have additional administration considerations discussed below.
European Aztreonam Avibactam Renal Dosing
The European/UK SmPC provides a separate renal-dosing table.
The current electronic Medicines Compendium information was updated May 28, 2026, with text revision 05/2026.
European/UK SmPC renal dosing
| Estimated CrCl | Loading dose | Maintenance dose | Interval | Infusion |
|---|---|---|---|---|
| >50 mL/min | 2 g / 0.67 g | 1.5 g / 0.5 g | Every 6 hours | 3 hours |
| >30 to ≤50 mL/min | 2 g / 0.67 g | 0.75 g / 0.25 g | Every 6 hours | 3 hours |
| >15 to ≤30 mL/min | 1.35 g / 0.45 g | 0.675 g / 0.225 g | Every 8 hours | 3 hours |
| ≤15 mL/min with intermittent HD | 1 g / 0.33 g | 0.675 g / 0.225 g | Every 12 hours | 3 hours |
The European SmPC also specifically states that no dose adjustment is required for mild renal impairment defined as estimated CrCl >50 to ≤80 mL/min.
Source: European/UK Emblaveo SmPC, revision 05/2026.
U.S. vs European Aztreonam Avibactam Renal Dosing
The overall dosing structure is similar, but the regulatory documents should be interpreted separately.
| Issue | U.S. FDA/DailyMed | European/UK SmPC |
|---|---|---|
| CrCl >50 mL/min | 2.67 g loading; 2 g maintenance q6h | 2 g/0.67 g loading; 1.5 g/0.5 g maintenance q6h |
| CrCl >30–50 | 2.67 g loading; 1 g maintenance q6h | 2 g/0.67 g loading; 0.75 g/0.25 g maintenance q6h |
| CrCl >15–30 | 1.8 g loading; 0.9 g maintenance q8h | 1.35 g/0.45 g loading; 0.675 g/0.225 g maintenance q8h |
| ≤15 mL/min | 1.33 g loading; 0.9 g maintenance q12h | 1 g/0.33 g loading; 0.675 g/0.225 g maintenance q12h with intermittent HD |
| Hemodialysis | Give after HD | Give after HD |
| CRRT | No specific fixed regimen in U.S. label | No fixed regimen; dosing should account for CRRT clearance |
| CrCl calculation | Cockcroft-Gault | Cockcroft-Gault |
Although the total amounts in several renal categories align, the regulatory frameworks and product information are not interchangeable, particularly when considering renal replacement therapies outside conventional intermittent hemodialysis.
Aztreonam Avibactam and Hemodialysis
Are aztreonam and avibactam removed by hemodialysis?
Yes. Current U.S. and European product information states that both aztreonam and avibactam are removed by hemodialysis.
This is why patients receiving intermittent hemodialysis have a specific renal-dosing category.
When should the dose be given on dialysis days?
The current U.S. and European labeling states that aztreonam-avibactam should be administered after the hemodialysis session on dialysis days.
This timing is important because hemodialysis can remove both components of the combination.
What If Renal Function Changes During Treatment?
Renal function should not necessarily be treated as static during therapy.
The current U.S. labeling specifically states that creatinine clearance should be monitored in patients with changing renal function and the dose adjusted accordingly.
This is particularly relevant when kidney function changes rapidly.
The prescribing information does not provide a separate universal “acute kidney injury dosing algorithm.” Instead, the labeled approach is to monitor renal function and adjust the regimen according to the applicable CrCl category.
For this reason, patients with changing renal function require clinical assessment rather than simply continuing the initial renal-dose category throughout treatment.
What Does the Label Say About CRRT?
Continuous renal replacement therapy (CRRT) requires additional caution.
What is established?
European product information states that there are insufficient data to provide a fixed dosing recommendation for renal replacement therapies other than intermittent hemodialysis.
It specifically discusses therapies such as:
- continuous veno-venous hemofiltration
- other continuous renal replacement approaches
- peritoneal dialysis
The European information indicates that patients receiving CRRT may require a higher dose than patients receiving intermittent hemodialysis, with dosing guided by CRRT clearance.
What is not established?
There is no single universally labeled CRRT dose that should be presented as equivalent to the standard CrCl-based table.
Therefore, this article does not provide a fixed CRRT dosing table.
For patients receiving CRRT, dosing should be determined using applicable product information and specialist clinical assessment, taking the characteristics and clearance of the renal replacement therapy into account.
Renal Dosing in Older Adults
Age alone does not create a separate aztreonam-avibactam dose category in the current U.S. and European product information.
The relevant consideration is renal function.
Because renal function can decline with age, estimated CrCl should be assessed according to the applicable dosing information rather than reducing the dose simply because a patient is older.
Hepatic and Pediatric Considerations
Hepatic impairment is not the primary focus of renal dosing, but it is useful to distinguish it from renal impairment.
The European SmPC states that no dosage adjustment is required for hepatic impairment, while recommending appropriate monitoring during treatment.
The U.S. labeling also does not provide a separate hepatic-adjustment regimen.
Pediatric use
There is no established pediatric dosing table that can simply be adapted from the adult renal categories.
The European SmPC states that safety and efficacy in patients under 18 years have not been established and that data are unavailable. The U.S. labeling likewise does not provide an established pediatric dosing regimen.
Therefore, the adult CrCl tables in this article should not be applied as a pediatric dosing algorithm.
Aztreonam Avibactam Renal Dosing: Key Points
The most important points to remember are:
- Renal dosing is based on estimated CrCl.
- Current U.S. and European labeling specifies the Cockcroft-Gault approach.
- Dose adjustment becomes particularly important as CrCl falls below 50 mL/min.
- Both the loading dose and maintenance dose can change with renal impairment.
- The dosing interval also changes at lower CrCl categories.
- Both aztreonam and avibactam are removed by hemodialysis.
- On hemodialysis days, the labeled regimen should be administered after the dialysis session.
- Changing renal function requires monitoring of CrCl and appropriate dose adjustment.
- There is no single universally labeled CRRT dose.
- U.S. and European product information should be interpreted according to the applicable regulatory setting.
Frequently Asked Questions
What is the aztreonam-avibactam dose for renal impairment?
The dose depends on estimated creatinine clearance. Current U.S. labeling provides separate regimens for CrCl >50, >30 to ≤50, >15 to ≤30, and ≤15 mL/min.
What is the aztreonam-avibactam dose for CrCl 30–50 mL/min?
Under current U.S. labeling, the >30 to ≤50 mL/min category uses a 2.67 g loading dose followed by 1 g every 6 hours, administered as a 3-hour infusion.
What is the dose for CrCl 15–30 mL/min?
For the U.S. >15 to ≤30 mL/min category, the labeled regimen is a 1.8 g loading dose followed by 0.9 g every 8 hours, with each dose infused over 3 hours.
Does aztreonam-avibactam require dose adjustment below CrCl 50 mL/min?
Yes. The current U.S. and European product information provides reduced dosing regimens for lower CrCl categories.
Is aztreonam-avibactam removed by hemodialysis?
Yes. Both aztreonam and avibactam are removed by hemodialysis according to current product information.
Should aztreonam-avibactam be given before or after dialysis?
Current U.S. and European labeling specifies administration after hemodialysis on dialysis days.
Does the loading dose change with renal impairment?
Yes. Unlike a simplified approach that changes only maintenance dosing, the current U.S. and European tables include different loading doses at lower renal-function categories.
Is there an established aztreonam-avibactam dose for CRRT?
There is no single universally labeled CRRT dose. European product information states that data are insufficient for a fixed recommendation and that dosing should account for CRRT clearance.
Regulatory Note
Aztreonam-avibactam dosing information can vary according to the applicable regulatory product information.
The U.S. dosing table in this article is based on the current U.S. EMBLAVEO labeling updated June 24, 2026.
The European table is based on the European/UK SmPC revised 05/2026.
These tables should not be combined into a single universal dosing recommendation.
Educational information only: This article is intended for general medical and educational reference. Aztreonam-avibactam dosing should be determined using the applicable current prescribing information and the patient’s clinical circumstances, renal function and treatment setting. It does not replace professional medical advice.