Ceftolozano / tazobactam

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Zerbaxa: 1 g / 0.5 g, polvo, vial unidosis — Merck Sharp & Dohme LLC

¿Para qué sirve ceftolozano / tazobactam? Indicaciones autorizadas

1 INDICATIONS AND USAGE ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with…

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1 INDICATIONS AND USAGE ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. ( 1.1 ) Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. ( 1.2 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP). ( 1.3 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.4 ) 1.1 Complicated Intra-abdominal Infections ZERBAXA used in combination with metronidazole is indicated for the treatment of adult and pediatric patients (at least 32 weeks gestational age) with complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius . 1.2 Complicated Urinary Tract Infections, Including Pyelonephritis ZERBAXA is indicated for the treatment of adult and pediatric patients (at least 32 weeks gestational age) with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , and Pseudomonas aeruginosa . 1.3 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia ZERBAXA is indicated for the treatment of adult and pediatric patients (at least 32 weeks gestational age) with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae , Escherichia coli , Haemophilus influenzae , Klebsiella oxytoca , Klebsiella pneumoniae , Proteus mirabilis , Pseudomonas aeruginosa , and Serratia marcescens . 1.4 Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

FDA (DailyMed) · ZERBAXA · Indications and usage · texto original en inglés

Contraindicaciones de ceftolozano / tazobactam

4 CONTRAINDICATIONS ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. ( 4 )

FDA (DailyMed) · ZERBAXA · Contraindications · texto original en inglés

Ajuste en insuficiencia renal

Parámetro que cita la fuente: CrCl (aclaramiento de creatinina) · Diálisis / TRRC · TFGe (filtrado glomerular estimado)

Pediatric patients with HABP/VABP weighing greater than 40 kg should not exceed a maximum dose of 3 g. 8 to 14 days HABP/VABP (from 2 years and older) ZERBAXA 75 mg/kg Provides 50 mg/kg ceftolozane and 25 mg/kg tazobactam. up to a maximum dose of 3 g 8 to 14 days Dosage adjustment is recommended in adult patients and in pediatric patients aged 2 years of age and older with renal impairment. There is insufficient information to recommend a dosage for pediatric patients younger than 2 years of age with renal impairment.

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

See Table 3 for the recommended dosage in adult patients with renal impairment, [see Dosage and Administration (2.3) ] Table 1:

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

See Table 4 for the recommended dosage in pediatric patients with renal impairment [see Dosage and Administration (2.4) ] .

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

Provides 2 g ceftolozane and 1 g tazobactam. 2 hours 8 to 14 days Pediatric patients from 2 years and older ZERBAXA 75 mg/kg Provides 50 mg/kg ceftolozane and 25 mg/kg tazobactam. up to a maximum dose of 3 g 2.3 Recommended Dosage in Adult Patients with Renal Impairment The recommended dosage of ZERBAXA in adult patients with renal impairment is based on CrCl as described in Table 3.

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

For patients with changing renal function, monitor CrCl at least daily and adjust the dosage of ZERBAXA accordingly [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

Recommended Dosage of ZERBAXA in Adult Patients with Renal Impairment Estimated CrCl (mL/min) Estimated CrCl using the Cockcroft-Gault formula Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections, Including Pyelonephritis Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Dosage Infusion time Dosage Infusion time 51 to less than 90 ZERBAXA 1.5 g Provides 1 g…

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Recommended Dosage of ZERBAXA in Adult Patients with Renal Impairment Estimated CrCl (mL/min) Estimated CrCl using the Cockcroft-Gault formula Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections, Including Pyelonephritis Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Dosage Infusion time Dosage Infusion time 51 to less than 90 ZERBAXA 1.5 g Provides 1 g ceftolozane and 0.5 g tazobactam. intravenously every 8 hours 1 hour ZERBAXA 3 g Provides 2 g ceftolozane and 1 g tazobactam. intravenously every 8 hours 1 hour 30 to 50 ZERBAXA 750 mg Provides 500 mg ceftolozane and 250 mg tazobactam. intravenously every 8 hours ZERBAXA 1.5 g intravenously every 8 hours 15 to 29 ZERBAXA 375 mg Provides 250 mg ceftolozane and 125 mg tazobactam. intravenously every 8 hours ZERBAXA 750 mg intravenously every 8 hours Less than 15 (not receiving intermittent hemodialysis) ZERBAXA dosage not established ZERBAXA dosage not established Receiving Intermittent Hemodialysis A single loading dose of ZERBAXA 750 mg followed by a ZERBAXA 150 mg Provides 100 mg ceftolozane and 50 mg tazobactam. maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on intermittent hemodialysis days, administer the dose at the earliest possible time following completion of dialysis) A single loading dose of ZERBAXA 2.25 g Provides 1.5 g ceftolozane and 0.75 g tazobactam. followed by a ZERBAXA 450 mg Provides 300 mg ceftolozane and 150 mg tazobactam. maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on intermittent hemodialysis days, administer the dose at the earliest possible time following completion of dialysis) 2.4 Recommended Dosage in Pediatric Patients with Renal Impairment The recommended dosage of ZERBAXA in pediatric patients 2 years of age and older with renal impairment based on an estimated GFR is described in Table 4.

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

For patients with changing renal function, monitor eGFR at least daily and adjust the dosage of ZERBAXA accordingly [see Use in Special Populations (8.4 and 8.6) and Clinical Pharmacology (12.3) ] . ZERBAXA is not recommended in pediatric patients less than 2 years of age with renal impairment [see Use in Specific Populations (8.4) ].

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

Recommended Dosage Regimens for ZERBAXA in Pediatric Patients 2 years of age and older with Renal Impairment For pediatric patients with cUTI or cIAI and renal impairment weighing greater than 50 kg, do not exceed the recommended dose for adults with renal impairment (see Table 3 ). For pediatric patients with HABP/VABP and renal impairment weighing greater than 40 kg, do not exceed the recommended dose for adults…

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Recommended Dosage Regimens for ZERBAXA in Pediatric Patients 2 years of age and older with Renal Impairment For pediatric patients with cUTI or cIAI and renal impairment weighing greater than 50 kg, do not exceed the recommended dose for adults with renal impairment (see Table 3 ). For pediatric patients with HABP/VABP and renal impairment weighing greater than 40 kg, do not exceed the recommended dose for adults with renal impairment (See Table 3 ). Estimated GFR Estimate eGFR using an equation validated in pediatric patients in the approved age range. (mL/min/1.73 m 2 ) Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections, including Pyelonephritis Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Dosage Infusion time Dosage Infusion time 51 to less than 90 ZERBAXA 30 mg/kg Provides 20 mg/kg ceftolozane and 10 mg/kg tazobactam. intravenously every 8 hours 1 hour ZERBAXA 75 mg/kg Provides 50 mg/kg ceftolozane and 25 mg/kg tazobactam. intravenously every 8 hours 2 hours 30 to 50 ZERBAXA 15 mg/kg Provides 10 mg/kg ceftolozane and 5 mg/kg tazobactam. intravenously every 8 hours ZERBAXA 37.5 mg/kg Provides 25 mg/kg ceftolozane and 12.5 mg/kg tazobactam. intravenously every 8 hours 15 to 29 ZERBAXA 7.5 mg/kg Provides 5 mg/kg ceftolozane and 2.5 mg/kg tazobactam intravenously every 8 hours ZERBAXA 18.75 mg/kg Provides 12.5 mg/kg ceftolozane and 6.25 mg/kg tazobactam. intravenously every 8 hours Less than 15 (not receiving intermittent hemodialysis) ZERBAXA dosage not established ZERBAXA dosage not established Receiving Intermittent Hemodialysis A single loading dose of ZERBAXA 15 mg/kg followed by a ZERBAXA 3 mg/kg Provides 2 mg/kg ceftolozane and 1 mg/kg tazobactam. maintenance dose administered 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) A single loading dose of ZERBAXA 45 mg/kg Provides 30 mg/kg ceftolozane and 15 mg/kg tazobactam followed by a ZERBAXA 9 mg/kg Provides 6 mg/kg ceftolozane and 3 mg/kg tazobactam maintenance dose administered 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) 2.5 Preparation of Solutions ZERBAXA does not contain a bacteriostatic preservative.

FDA (DailyMed) · ZERBAXA · Dosage and administration · texto original en inglés

Recommended Dosage of ZERBAXA by Infection in Adult Patients (• 2.1 ) Infection | Dose | Duration of Treatment cIAI Used in conjunction with metronidazole 500 mg intravenously every 8 hours | ZERBAXA 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour Provides 1 g ceftolozane and 0.5 g tazobactam | 4 to 14 days cUTI, Including Pyelonephritis | ZERBAXA 1.5 g | 7 days HABP/VABP | ZERBAXA 3 g…

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Recommended Dosage of ZERBAXA by Infection in Adult Patients (• 2.1 ) Infection | Dose | Duration of Treatment

cIAI Used in conjunction with metronidazole 500 mg intravenously every 8 hours | ZERBAXA 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour Provides 1 g ceftolozane and 0.5 g tazobactam | 4 to 14 days

cUTI, Including Pyelonephritis | ZERBAXA 1.5 g | 7 days

HABP/VABP | ZERBAXA 3 g Provides 2 g ceftolozane and 1 g tazobactam | 8 to 14 days

Recommended Dosage of ZERBAXA by infection in Pediatric Patients (at least 32 weeks gestational age) (• 2.2 ) Infection | Dose | Duration of Treatment

cIAI Used in conjunction with metronidazole. | ZERBAXA 30 mg/kg Provides 20 mg/kg ceftolozane and 10 mg/kg tazobactam. Pediatric patients with cIAI or cUTI weighing greater than 50 kg should not exceed a maximum dose of 1.5 g. up to a maximum dose of 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour in pediatric patients with cIAI or cUTI. Provides 1 g ceftolozane and 0.5 g tazobactam. | 5 to 14 days

cUTI, Including Pyelonephritis | ZERBAXA 30 mg/kg up to a maximum dose of 1.5 g | 7 to 14 days

HABP/VABP (at least 32 weeks gestational age to less than 2 years) | ZERBAXA 60 mg/kg Provides 40 mg/kg ceftolozane and 20 mg/kg tazobactam. up to a maximum dose of 3 g Administer all doses of ZERBAXA intravenously every 8 hours over 2 hours in pediatric patients with HABP/VABP. Provides 2 g ceftolozane and 1 g tazobactam. Pediatric patients with HABP/VABP weighing greater than 40 kg should not exceed a maximum dose of 3 g. | 8 to 14 days

HABP/VABP (from 2 years and older) | ZERBAXA 75 mg/kg Provides 50 mg/kg ceftolozane and 25 mg/kg tazobactam. up to a maximum dose of 3 g | 8 to 14 days

Table 1: Recommended Dosage of ZERBAXA by Infection in Adult Patients Infection | Dose | Frequency | Infusion Time | Duration of Treatment

Complicated Intra-abdominal Infections Used in conjunction with metronidazole 500 mg intravenously every 8 hours | ZERBAXA 1.5 g Provides 1 g ceftolozane and 0.5 g tazobactam | Every 8 Hours | 1 hour | 4 to 14 days

Complicated Urinary Tract Infections, Including Pyelonephritis | ZERBAXA 1.5 g | Every 8 Hours | 1 hour | 7 days

Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia | ZERBAXA 3 g Provides 2 g ceftolozane and 1 g tazobactam | Every 8 Hours | 1 hour | 8 to 14 days

Table 2: Recommended Dosage of ZERBAXA by Infection in Pediatric Patients (at least 32 weeks gestational age) Infection | Age Range | Dose | Frequency | Infusion time | Duration of treatment

Complicated Intra-abdominal Infections Used in conjunction with metronidazole. | All pediatric patients (at least 32 weeks gestational age) | ZERBAXA 30 mg/kg Provides 20 mg/kg ceftolozane and 10 mg/kg tazobactam. up to a maximum dose of 1.5 g For pediatric patients with cUTI or cIAI weighing greater than 50 kg, do not exceed a maximum dose of 1.5 g. Provides 1 g ceftolozane and 0.5 g tazobactam | Every 8 hours | 1 hour | 5 to 14 days

Complicated Urinary Tract Infections, Including Pyelonephritis | ZERBAXA 30 mg/kg up to a maximum dose of 1.5 g | 1 hour | 7 to 14 days

Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia | Pediatric patients from at least 32 weeks of gestational age to less than 2 years | ZERBAXA 60 mg/kg Provides 40 mg/kg ceftolozane and 20 mg/kg tazobactam. up to a maximum dose of 3 g For pediatric patients with HABP/VABP weighing greater than 40 kg, do not exceed a maximum dose of 3 g. Provides 2 g ceftolozane and 1 g tazobactam. | 2 hours | 8 to 14 days

Pediatric patients from 2 years and older | ZERBAXA 75 mg/kg Provides 50 mg/kg ceftolozane and 25 mg/kg tazobactam. up to a maximum dose of 3 g

Table 3: Recommended Dosage of ZERBAXA in Adult Patients with Renal Impairment Estimated CrCl (mL/min) Estimated CrCl using the Cockcroft-Gault formula | Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections, Including Pyelonephritis | Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Dosage | Infusion time | Dosage | Infusion time

51 to less than 90 | ZERBAXA 1.5 g Provides 1 g ceftolozane and 0.5 g tazobactam. intravenously every 8 hours | 1 hour | ZERBAXA 3 g Provides 2 g ceftolozane and 1 g tazobactam. intravenously every 8 hours | 1 hour

30 to 50 | ZERBAXA 750 mg Provides 500 mg ceftolozane and 250 mg tazobactam. intravenously every 8 hours | ZERBAXA 1.5 g intravenously every 8 hours

15 to 29 | ZERBAXA 375 mg Provides 250 mg ceftolozane and 125 mg tazobactam. intravenously every 8 hours | ZERBAXA 750 mg intravenously every 8 hours

Less than 15 (not receiving intermittent hemodialysis) | ZERBAXA dosage not established | ZERBAXA dosage not established

Receiving Intermittent Hemodialysis | A single loading dose of ZERBAXA 750 mg followed by a ZERBAXA 150 mg Provides 100 mg ceftolozane and 50 mg tazobactam. maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on intermittent hemodialysis days, administer the dose at the earliest possible time following completion of dialysis) | A single loading dose of ZERBAXA 2.25 g Provides 1.5 g ceftolozane and 0.75 g tazobactam. followed by a ZERBAXA 450 mg Provides 300 mg ceftolozane and 150 mg tazobactam. maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on intermittent hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)

Table 4: Recommended Dosage Regimens for ZERBAXA in Pediatric Patients 2 years of age and older with Renal Impairment For pediatric patients with cUTI or cIAI and renal impairment weighing greater than 50 kg, do not exceed the recommended dose for adults with renal impairment (see • Table 3 ). For pediatric patients with HABP/VABP and renal impairment weighing greater than 40 kg, do not exceed the recommended dose for adults with renal impairment (See • Table 3 ). Estimated GFR Estimate eGFR using an equation validated in pediatric patients in the approved age range. (mL/min/1.73 m 2 ) | Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections, including Pyelonephritis | Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Dosage | Infusion time | Dosage | Infusion time

51 to less than 90 | ZERBAXA 30 mg/kg Provides 20 mg/kg ceftolozane and 10 mg/kg tazobactam. intravenously every 8 hours | 1 hour | ZERBAXA 75 mg/kg Provides 50 mg/kg ceftolozane and 25 mg/kg tazobactam. intravenously every 8 hours | 2 hours

30 to 50 | ZERBAXA 15 mg/kg Provides 10 mg/kg ceftolozane and 5 mg/kg tazobactam. intravenously every 8 hours | ZERBAXA 37.5 mg/kg Provides 25 mg/kg ceftolozane and 12.5 mg/kg tazobactam. intravenously every 8 hours

15 to 29 | ZERBAXA 7.5 mg/kg Provides 5 mg/kg ceftolozane and 2.5 mg/kg tazobactam intravenously every 8 hours | ZERBAXA 18.75 mg/kg Provides 12.5 mg/kg ceftolozane and 6.25 mg/kg tazobactam. intravenously every 8 hours

Less than 15 (not receiving intermittent hemodialysis) | ZERBAXA dosage not established | ZERBAXA dosage not established

Receiving Intermittent Hemodialysis | A single loading dose of ZERBAXA 15 mg/kg followed by a ZERBAXA 3 mg/kg Provides 2 mg/kg ceftolozane and 1 mg/kg tazobactam. maintenance dose administered 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) | A single loading dose of ZERBAXA 45 mg/kg Provides 30 mg/kg ceftolozane and 15 mg/kg tazobactam followed by a ZERBAXA 9 mg/kg Provides 6 mg/kg ceftolozane and 3 mg/kg tazobactam maintenance dose administered 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)

Table 5: Preparation of Doses ZERBAXA (ceftolozane and tazobactam) Dose | Volume to Withdraw from Reconstituted Vial(s)

ZERBAXA 3 g (2 g and 1 g) | Two vials of 11.4 mL each (entire contents from two vials)

ZERBAXA 2.25 g (1.5 g and 0.75 g) | 11.4 mL from one vial (entire contents) and 5.7 mL from a second vial

ZERBAXA 1.5 g (1 g and 0.5 g) | 11.4 mL (entire contents from one vial)

ZERBAXA 750 mg (500 mg and 250 mg) | 5.7 mL

ZERBAXA 450 mg (300 mg and 150 mg) | 3.5 mL

ZERBAXA 375 mg (250 mg and 125 mg) | 2.9 mL

ZERBAXA 150 mg (100 mg and 50 mg) | 1.2 mL

FDA (DailyMed) · ZERBAXA · Dosage and administration table · texto original en inglés

See Table 4 for recommended dosage in pediatric patients 2 years of age and older with renal impairment [see Dosage and Administration (2.4) ] . There is insufficient information to establish dosing for pediatric patients younger than 2 years of age with renal impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ].

FDA (DailyMed) · ZERBAXA · Use in specific populations · texto original en inglés

ZERBAXA is not recommended in pediatric patients younger than 2 years of age with renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. 8.5 Geriatric Use Of the 1015 patients treated with ZERBAXA in the Phase 3 cIAI and cUTI clinical trials, 250 (24.6%) were 65 years or older, including 113 (11.1%) 75 years or older.

FDA (DailyMed) · ZERBAXA · Use in specific populations · texto original en inglés

ZERBAXA is substantially excreted by the kidney and the risk of adverse reactions to ZERBAXA may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Adjust dosage for elderly patients based on renal function [see Dosage and Administration (2.2) and Clinical…

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ZERBAXA is substantially excreted by the kidney and the risk of adverse reactions to ZERBAXA may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Adjust dosage for elderly patients based on renal function [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] . 8.6 Renal Impairment Adult Patients See Table 3 for recommended dosage in adult patients with a CrCl less than 90 mL/min or CrCl less than 15 mL/min and receiving intermittent hemodialysis. Dosage is not established for adult patients with a CrCl <15 mL/min who are not receiving intermittent hemodialysis. [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Pediatric Patients See Table 4 for recommended dosage in pediatric patients 2 years of age and older with an eGFR less than 90 mL/min/1.73 m 2 or eGFR less than 15 mL/min/1.73 m 2 and receiving intermittent hemodialysis. Dosage is not established for pediatric patients with an eGFR <15 mL/min/1.73m 2 who are not receiving intermittent hemodialysis. There is insufficient information to recommend dosage adjustment for pediatric patients younger than 2 years of age with renal impairment . [See Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] .

FDA (DailyMed) · ZERBAXA · Use in specific populations · texto original en inglés

Ajuste en insuficiencia hepática

No effects on the physical development, neurological function, or fertility and reproductive ability of first generation (F1) pups were noted, but postnatal body weights for F1 pups delivered to dams receiving 320 and 1280 mg/kg/day tazobactam were significantly reduced 21 days after delivery.

FDA (DailyMed) · ZERBAXA · Use in specific populations · texto original en inglés

Reconstitución de ceftolozano / tazobactam

Agua inyectable o NaCl 0.9%; consultar sección 2.3 para volumen y preparación de la dosis.

Dilución de ceftolozano / tazobactam

NaCl 0.9% o glucosa 5%; consultar sección 2.3.

Administración de ceftolozano / tazobactam

Perfusión IV de 1 hora.

Estabilidad y periodo de validez

Compatibilidad de ceftolozano / tazobactam

Compatible con

• NaCl 0.9% y glucosa 5% como diluyentes; no implica compatibilidad entre medicamentos.

Incompatible con

• No mezclar con otros medicamentos: compatibilidad no establecida.

Conservación y protección de la luz

2–8 °C; proteger de la luz.

Fotoprotección del vial en almacenamiento. No se extrapola a bolsa o línea.

¿Se puede triturar?

No aplica: inyectable.

Advertencias

• Verificar ajuste renal en la etiqueta y protocolo institucional.
• No congelar la solución diluida.

Fuentes

1. FDA (DailyMed) · ZERBAXAMerck Sharp & Dohme LLC · 1 g / 0.5 g, polvo, vial unidosis · versión 2026-05-12

Identificación

SNOMED CT (VTM)

161941000140107

RxNorm

1597614