Zerbaxa (ceftolozane sulfate/tazobactam sodium)

Ceftolozane and tazobactam is a fixed combination containing a 2:1 ratio of ceftolozane to tazobactam.

The ceftolozane component is provided as ceftolozane sulfate (dosage of this component is expressed in terms of ceftolozane); the tazobactam component is provided as tazobactam sodium (dosage of this component is expressed in terms of tazobactam).

Dosage of the fixed combination of ceftolozane and tazobactam is expressed in terms of the total of the ceftolozane and tazobactam content.

Each single-dose vial of ceftolozane and tazobactam contains a total of 1.5 g (i.e., 1 g of ceftolozane and 0.5 g of tazobactam).

Dosage adjustments based solely on age are not needed when ceftolozane and tazobactam is used in geriatric patients. However, because geriatric patients are more likely to have decreased renal function and because dosage of ceftolozane and tazobactam needs to be adjusted based on renal impairment, dosage should be selected with caution and it may be useful to monitor renal function.

Dosage adjustments are not needed when ceftolozane and tazobactam is used in adults with hepatic impairment.

Dosage of ceftolozane and tazobactam must be adjusted in adults with creatinine clearances of 50 mL/minute or less, including those undergoing hemodialysis. (See Table 2.)

Creatinine clearance should be monitored at least once daily in patients with changing renal function and dosage of ceftolozane and tazobactam adjusted accordingly.

Table 2. Ceftolozane and Tazobactam Dosage for Adults with Renal Impairment

Estimated Creatinine Clearance Recommended Dosage (mL/minute) 30-50 750 mg (ceftolozane 500 mg and tazobactam 250 mg) every 8 hours 15-29 375 mg (ceftolozane 250 mg and tazobactam 125 mg) every 8 hours End-stage renal disease on Single loading dose of 750 mg hemodialysis (ceftolozane 500 mg and tazobactam 250 mg) followed by maintenance dosage of 150 mg (ceftolozane 100 mg and tazobactam 50 mg) every 8 hours

On hemodialysis days, the dose should be administered as soon as possible after dialysis.

Ceftolozane and tazobactam is administered by IV infusion.

No dosing information is available for this tab.

No dosing information is available for this tab.

The following drug interactions are based on studies using the fixed combination containing ceftolozane and tazobactam, ceftolozane alone, or tazobactam alone. When ceftolozane and tazobactam is used, interactions associated with both drugs in the fixed combination should be considered.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Embryofetal development studies in mice and rats using ceftolozane dosages associated with exposures approximately 7 and 4 times, respectively, the exposure expected in humans receiving a ceftolozane dosage of 1 g three times daily did not reveal evidence of fetal toxicity. In a study in rats, ceftolozane administered during pregnancy and lactation was associated with decreased auditory startle response in male pups at postnatal day 60.

Embryofetal development studies in rats using tazobactam dosages approximately 19 times the recommended human dosage revealed evidence of maternal toxicity (decreased food consumption and body weight gain), but no evidence of fetal toxicity. In a study in rats, tazobactam administered during pregnancy and lactation in dosages approximately 8 times the recommended human dosage produced decreased maternal food consumption and body weight gain at the end of gestation and an increased incidence of stillbirths. Although pups of dams receiving tazobactam in dosages of 320-1280 mg/kg daily had substantially reduced postnatal body weight at 21 days after delivery, there was no evidence of effects on development, function, learning, or fertility of the pups.

There are no adequate and controlled studies using ceftolozane and tazobactam in pregnant women, and the drug should be used during pregnancy only if potential benefits to the woman justify potential risks to the fetus.

Because it is not known whether ceftolozane or tazobactam is distributed into human milk, the fixed combination of ceftolozane and tazobactam should be used with caution in nursing women.

No enhanced messaging available.