Dosing for ZERBAXA\u00ae (ceftolozane and tazobactam)<\/strong><\/h1><\/div>\n\n\n\n\n<\/div>\n\n\n\nLearn about:<\/strong><\/h2><\/div>\n\n\n\n\n- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/mark><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
Dosing and administration<\/h2><\/div>\n\n\n\n<\/div>\n\n\n\nDosage for adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP\/VABP)a,b<\/span><\/sup><\/strong><\/h3><\/div>\n\n\n\n<\/div>\n\n\n\nThe recommended dose of ZERBAXA in adult patients 18 years and older with HABP\/VABP and creatinine clearance (CrCl) greater than 50 mL\/min<\/span> is 3 grams<\/span> (two 1.5 g vials) over 1-hour period every 8 hours for 8 to 14 days. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/p>\n\n\n\n<\/div>\n\n\n\nThere is insufficient information to recommend a dosage regimen for pediatric patients with HABP\/VABP (birth to less than 18 years of age).<\/p>\n\n\n\n
\n\n\n![\"\"](\"https:\/\/www.merckconnect.com\/zerbaxa\/wp-content\/uploads\/sites\/130\/2025\/10\/CAT_Two_Vial_Color_3g_dk_RGB.svg\")
Vials not actual size<\/figcaption>Vials not actual size<\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n<\/div>\n<\/div>\n\n\n\n<\/div>\n\n\n\nRenal dosing adjustments for adult patients with HABP\/VABP per estimated CrCl (mL\/min)a,b<\/sup><\/strong><\/h3><\/div>\n\n\n\n<\/div>\n\n\n\n- 30 to 50<\/strong> CrCl (mL\/min)<\/strong> 1.5 g<\/span> (1 g and 0.5 g<\/span>) intravenously every 8 hours<\/li>
- 15 to 29<\/strong> CrCl (mL\/min) <\/strong>750 mg (500 mg<\/span> and 250 mg<\/span>) intravenously every 8 hours<\/li>
- For patients with end-stage renal disease on hemodialysis: a single loading dose of <\/span>2.25 g (1.5 g<\/span> and 0.75 g) <\/span>followed by a 450-mg (<\/span>300 mg<\/span> and 150 mg) maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis).<\/li>
- The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/li>
- For patients with changing renal function, monitor CrCl at least daily and adjust dosage of ZERBAXA accordingly.<\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
a<\/sup>Creatinine clearance (CrCl) estimated using Cockcroft-Gault formula.<\/p><\/div><\/div>\n\n\n\nb<\/sup>All doses of ZERBAXA are administered over 1 hour.<\/p><\/div><\/div>\n\n\n\n<\/div>\n\n\n\n- Back to top<\/a><\/em><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
3-g dose for HABP\/VABP selected based on Phase 1 PK\/PD study<\/strong>1<\/strong><\/sup><\/h2><\/div>\n\n\n\n<\/div>\n\n\n\n\n\n![\"Graph](\"https:\/\/www.merckconnect.com\/zerbaxa\/wp-content\/uploads\/sites\/130\/2024\/09\/dosing_graph.svg\")
![\"Graph](\"https:\/\/www.merckconnect.com\/zerbaxa\/wp-content\/uploads\/sites\/130\/2024\/09\/CAT_MIC_Chart_v2_mbl1.svg\" "\\"\\"")
<\/figure><\/div>\n<\/div>\n\n\n\n<\/div>\n<\/div>\n\n\n\n<\/div>\n\n\n\n- ZERBAXA at 3-g IV dose achieved target concentration in the epithelial lining fluid (ELF) over 100% of the dosing interval.<\/li><\/ul><\/div>\n\n\n\n
Image adapted from Caro L, Nicolau DP, De Waele JJ, et al. Lung penetration, bronchopulmonary pharmacokinetic\/pharmacodynamic profile and safety of 3 g of ceftolozane\/tazobactam administered to ventilated, critically ill patients with pneumonia. J Antimicrob Chemother.<\/em><\/span> 2020;75(6):1546-1553. https:\/\/doi.org\/10.1093\/jac\/dkaa049 \u00a9The Author(s) 2020 is licensed under Creative Commons 4.0 at http:\/\/creativecommons.org\/licenses\/by\/4.0\/<\/p>\n\n\n\n<\/div>\n\n\n\nPhase 1 PK\/PD Study Design<\/strong><\/h3><\/div>\n\n\n\n<\/div>\n\n\n\n- Following 1-hour intravenous infusions of ZERBAXA 3 g (ceftolozane 2 g and tazobactam 1 g<\/span>) or adjusted based on renal function every 8 hours in ventilated adult patients with confirmed or suspected pneumonia (N=22), mean pulmonary epithelial lining fluid-to-free plasma AUC ratios of ceftolozane and tazobactam were approximately 50% and 62%, respectively, and are similar to those in healthy subjects (approximately 61% and 63%, respectively) receiving ZERBAXA 1.5 g <\/span>(ceftolozane 1 g<\/span> and tazobactam <\/span>0.5 g)<\/span><\/li>
- Minimum ceftolozane and tazobactam epithelial lung lining fluid concentrations in ventilated subjects at the end of the dosing interval were <\/span>8.2 mcg\/mL and 1.0 mcg\/mL<\/span>,<\/span> respectively<\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
- Back to top<\/a><\/em><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
Dosage for adult patients (18 years and older) with cIAI and cUTI with CrCl > 50 mL\/mina,b<\/sup><\/span><\/strong><\/h2><\/div>\n\n\n\n<\/div>\n\n\n\nThe duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/p>\n\n\n\n
<\/div>\n\n\n\n\n\n
Learn about:<\/strong><\/h2><\/div>\n\n\n\n\n- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/mark><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
Dosing and administration<\/h2><\/div>\n\n\n\n<\/div>\n\n\n\nDosage for adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP\/VABP)a,b<\/span><\/sup><\/strong><\/h3><\/div>\n\n\n\n<\/div>\n\n\n\nThe recommended dose of ZERBAXA in adult patients 18 years and older with HABP\/VABP and creatinine clearance (CrCl) greater than 50 mL\/min<\/span> is 3 grams<\/span> (two 1.5 g vials) over 1-hour period every 8 hours for 8 to 14 days. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/p>\n\n\n\n<\/div>\n\n\n\nThere is insufficient information to recommend a dosage regimen for pediatric patients with HABP\/VABP (birth to less than 18 years of age).<\/p>\n\n\n\n
\n\n\nVials not actual size<\/figcaption>Vials not actual size<\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n<\/div>\n<\/div>\n\n\n\n<\/div>\n\n\n\nRenal dosing adjustments for adult patients with HABP\/VABP per estimated CrCl (mL\/min)a,b<\/sup><\/strong><\/h3><\/div>\n\n\n\n<\/div>\n\n\n\n- 30 to 50<\/strong> CrCl (mL\/min)<\/strong> 1.5 g<\/span> (1 g and 0.5 g<\/span>) intravenously every 8 hours<\/li>
- 15 to 29<\/strong> CrCl (mL\/min) <\/strong>750 mg (500 mg<\/span> and 250 mg<\/span>) intravenously every 8 hours<\/li>
- For patients with end-stage renal disease on hemodialysis: a single loading dose of <\/span>2.25 g (1.5 g<\/span> and 0.75 g) <\/span>followed by a 450-mg (<\/span>300 mg<\/span> and 150 mg) maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis).<\/li>
- The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/li>
- For patients with changing renal function, monitor CrCl at least daily and adjust dosage of ZERBAXA accordingly.<\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
a<\/sup>Creatinine clearance (CrCl) estimated using Cockcroft-Gault formula.<\/p><\/div><\/div>\n\n\n\nb<\/sup>All doses of ZERBAXA are administered over 1 hour.<\/p><\/div><\/div>\n\n\n\n<\/div>\n\n\n\n- Back to top<\/a><\/em><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
3-g dose for HABP\/VABP selected based on Phase 1 PK\/PD study<\/strong>1<\/strong><\/sup><\/h2><\/div>\n\n\n\n<\/div>\n\n\n\n\n\n<\/figure><\/div>\n<\/div>\n\n\n\n<\/div>\n<\/div>\n\n\n\n<\/div>\n\n\n\n- ZERBAXA at 3-g IV dose achieved target concentration in the epithelial lining fluid (ELF) over 100% of the dosing interval.<\/li><\/ul><\/div>\n\n\n\n
Image adapted from Caro L, Nicolau DP, De Waele JJ, et al. Lung penetration, bronchopulmonary pharmacokinetic\/pharmacodynamic profile and safety of 3 g of ceftolozane\/tazobactam administered to ventilated, critically ill patients with pneumonia. J Antimicrob Chemother.<\/em><\/span> 2020;75(6):1546-1553. https:\/\/doi.org\/10.1093\/jac\/dkaa049 \u00a9The Author(s) 2020 is licensed under Creative Commons 4.0 at http:\/\/creativecommons.org\/licenses\/by\/4.0\/<\/p>\n\n\n\n<\/div>\n\n\n\nPhase 1 PK\/PD Study Design<\/strong><\/h3><\/div>\n\n\n\n<\/div>\n\n\n\n- Following 1-hour intravenous infusions of ZERBAXA 3 g (ceftolozane 2 g and tazobactam 1 g<\/span>) or adjusted based on renal function every 8 hours in ventilated adult patients with confirmed or suspected pneumonia (N=22), mean pulmonary epithelial lining fluid-to-free plasma AUC ratios of ceftolozane and tazobactam were approximately 50% and 62%, respectively, and are similar to those in healthy subjects (approximately 61% and 63%, respectively) receiving ZERBAXA 1.5 g <\/span>(ceftolozane 1 g<\/span> and tazobactam <\/span>0.5 g)<\/span><\/li>
- Minimum ceftolozane and tazobactam epithelial lung lining fluid concentrations in ventilated subjects at the end of the dosing interval were <\/span>8.2 mcg\/mL and 1.0 mcg\/mL<\/span>,<\/span> respectively<\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
- Back to top<\/a><\/em><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<\/div>\n\n\n\n
Dosage for adult patients (18 years and older) with cIAI and cUTI with CrCl > 50 mL\/mina,b<\/sup><\/span><\/strong><\/h2><\/div>\n\n\n\n<\/div>\n\n\n\nThe duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/p>\n\n\n\n
<\/div>\n\n\n\n\n\n
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/mark><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n
<\/div>\n\n\n\nDosing and administration<\/h2><\/div>\n\n\n\n
<\/div>\n\n\n\nDosage for adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP\/VABP)a,b<\/span><\/sup><\/strong><\/h3><\/div>\n\n\n\n
<\/div>\n\n\n\nThe recommended dose of ZERBAXA in adult patients 18 years and older with HABP\/VABP and creatinine clearance (CrCl) greater than 50 mL\/min<\/span> is 3 grams<\/span> (two 1.5 g vials) over 1-hour period every 8 hours for 8 to 14 days. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/p>\n\n\n\n
<\/div>\n\n\n\nThere is insufficient information to recommend a dosage regimen for pediatric patients with HABP\/VABP (birth to less than 18 years of age).<\/p>\n\n\n\n
\n\n\nVials not actual size<\/figcaption> Vials not actual size<\/figcaption><\/figure><\/div>\n<\/div>\n\n\n\n <\/div>\n<\/div>\n\n\n\n<\/div>\n\n\n\nRenal dosing adjustments for adult patients with HABP\/VABP per estimated CrCl (mL\/min)a,b<\/sup><\/strong><\/h3><\/div>\n\n\n\n
<\/div>\n\n\n\n- 30 to 50<\/strong> CrCl (mL\/min)<\/strong> 1.5 g<\/span> (1 g and 0.5 g<\/span>) intravenously every 8 hours<\/li>
- 15 to 29<\/strong> CrCl (mL\/min) <\/strong>750 mg (500 mg<\/span> and 250 mg<\/span>) intravenously every 8 hours<\/li>
- For patients with end-stage renal disease on hemodialysis: a single loading dose of <\/span>2.25 g (1.5 g<\/span> and 0.75 g) <\/span>followed by a 450-mg (<\/span>300 mg<\/span> and 150 mg) maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis).<\/li>
- The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/li>
- For patients with changing renal function, monitor CrCl at least daily and adjust dosage of ZERBAXA accordingly.<\/li><\/ul><\/div>\n\n\n\n
<\/div>\n\n\n\na<\/sup>Creatinine clearance (CrCl) estimated using Cockcroft-Gault formula.<\/p><\/div><\/div>\n\n\n\n
b<\/sup>All doses of ZERBAXA are administered over 1 hour.<\/p><\/div><\/div>\n\n\n\n
<\/div>\n\n\n\n- Back to top<\/a><\/em><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n
<\/div>\n\n\n\n3-g dose for HABP\/VABP selected based on Phase 1 PK\/PD study<\/strong>1<\/strong><\/sup><\/h2><\/div>\n\n\n\n
<\/div>\n\n\n\n\n\n<\/figure><\/div>\n<\/div>\n\n\n\n<\/div>\n<\/div>\n\n\n\n<\/div>\n\n\n\n- ZERBAXA at 3-g IV dose achieved target concentration in the epithelial lining fluid (ELF) over 100% of the dosing interval.<\/li><\/ul><\/div>\n\n\n\n
Image adapted from Caro L, Nicolau DP, De Waele JJ, et al. Lung penetration, bronchopulmonary pharmacokinetic\/pharmacodynamic profile and safety of 3 g of ceftolozane\/tazobactam administered to ventilated, critically ill patients with pneumonia. J Antimicrob Chemother.<\/em><\/span> 2020;75(6):1546-1553. https:\/\/doi.org\/10.1093\/jac\/dkaa049 \u00a9The Author(s) 2020 is licensed under Creative Commons 4.0 at http:\/\/creativecommons.org\/licenses\/by\/4.0\/<\/p>\n\n\n\n
<\/div>\n\n\n\nPhase 1 PK\/PD Study Design<\/strong><\/h3><\/div>\n\n\n\n
<\/div>\n\n\n\n- Following 1-hour intravenous infusions of ZERBAXA 3 g (ceftolozane 2 g and tazobactam 1 g<\/span>) or adjusted based on renal function every 8 hours in ventilated adult patients with confirmed or suspected pneumonia (N=22), mean pulmonary epithelial lining fluid-to-free plasma AUC ratios of ceftolozane and tazobactam were approximately 50% and 62%, respectively, and are similar to those in healthy subjects (approximately 61% and 63%, respectively) receiving ZERBAXA 1.5 g <\/span>(ceftolozane 1 g<\/span> and tazobactam <\/span>0.5 g)<\/span><\/li>
- Minimum ceftolozane and tazobactam epithelial lung lining fluid concentrations in ventilated subjects at the end of the dosing interval were <\/span>8.2 mcg\/mL and 1.0 mcg\/mL<\/span>,<\/span> respectively<\/li><\/ul><\/div>\n\n\n\n
<\/div>\n\n\n\n- Back to top<\/a><\/em><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>
- Dosage for adult patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosage for pediatric patients with cIAI and cUTI<\/a><\/em><\/li>
- Dosing, administration, and billing guide<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n
<\/div>\n\n\n\nDosage for adult patients (18 years and older) with cIAI and cUTI with CrCl > 50 mL\/mina,b<\/sup><\/span><\/strong><\/h2><\/div>\n\n\n\n
<\/div>\n\n\n\nThe duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.<\/p>\n\n\n\n
<\/div>\n\n\n\n\n\n - Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- Minimum ceftolozane and tazobactam epithelial lung lining fluid concentrations in ventilated subjects at the end of the dosing interval were <\/span>8.2 mcg\/mL and 1.0 mcg\/mL<\/span>,<\/span> respectively<\/li><\/ul><\/div>\n\n\n\n
- Following 1-hour intravenous infusions of ZERBAXA 3 g (ceftolozane 2 g and tazobactam 1 g<\/span>) or adjusted based on renal function every 8 hours in ventilated adult patients with confirmed or suspected pneumonia (N=22), mean pulmonary epithelial lining fluid-to-free plasma AUC ratios of ceftolozane and tazobactam were approximately 50% and 62%, respectively, and are similar to those in healthy subjects (approximately 61% and 63%, respectively) receiving ZERBAXA 1.5 g <\/span>(ceftolozane 1 g<\/span> and tazobactam <\/span>0.5 g)<\/span><\/li>
- Dosage for adult patients with HABP\/VABP<\/a><\/em><\/li>
- 15 to 29<\/strong> CrCl (mL\/min) <\/strong>750 mg (500 mg<\/span> and 250 mg<\/span>) intravenously every 8 hours<\/li>
- Phase 1 PK\/PD study<\/a><\/em><\/li>