Generic name: ceftolozane sulfate 1g in 10mL, tazobactam sodium 0.5g in 10mL
Dosage form: injection, powder, lyophilized, for solution
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The recommended dosage regimen is ZERBAXA 1.5 gram (g) (ceftolozane 1 g and tazobactam 0.5 g) for injection administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older and with normal renal function or mild renal impairment. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress (Table 1).
|Infection||Dose||Frequency||Infusion Time (hours)||Duration of Treatment|
|Complicated Intra-abdominal Infections*||1.5 g||Every 8 Hours||1||4-14 days|
|Complicated Urinary Tract Infections, including Pyelonephritis||1.5 g||Every 8 Hours||1||7 days|
Patients with Renal Impairment
Dose adjustment is required for patients whose creatinine clearance is 50 mL/min or less. Renal dose adjustments are listed in Table 2. 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)].
|Estimated CrCl (mL/min)*||Recommended Dosage Regimen for ZERBAXA 1.5 g (ceftolozane 1 g and tazobactam 0.5 g)†|
|30 to 50||750 mg (500 mg and 250 mg) intravenously every 8 hours|
|15 to 29||375 mg (250 mg and 125 mg) intravenously every 8 hours|
|End-stage renal disease (ESRD) on hemodialysis (HD)||A single loading dose of 750 mg (500 mg and 250 mg) followed by a 150 mg (100 mg and 50 mg) 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)|
Preparation of Solutions
ZERBAXA does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparing the infusion solution.
Preparation of doses:
Constitute the vial with 10 mL of sterile water for injection or 0.9% Sodium Chloride for Injection, USP and gently shake to dissolve. The final volume is approximately 11.4 mL. Caution: The constituted solution is not for direct injection.
To prepare the required dose, withdraw the appropriate volume determined from Table 3 from the reconstituted vial. Add the withdrawn volume to an infusion bag containing 100 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP.
|ZERBAXA (ceftolozane and tazobactam) Dose||Volume to Withdraw from Reconstituted Vial|
|1.5 g (1 g and 0.5 g)||11.4 mL (entire contents)|
|750 mg (500 mg and 250 mg)||5.7 mL|
|375 mg (250 mg and 125 mg)||2.9 mL|
|150 mg (100 mg and 50 mg)||1.2 mL|
Inspect drug products visually for particulate matter and discoloration prior to use. ZERBAXA infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.
Compatibility of ZERBAXA with other drugs has not been established. ZERBAXA should not be mixed with other drugs or physically added to solutions containing other drugs.
Storage of Constituted Solutions
Upon constitution with sterile water for injection or 0.9% sodium chloride injection, reconstituted ZERBAXA solution may be held for 1 hour prior to transfer and dilution in a suitable infusion bag.
Following dilution of the solution with 0.9% sodium chloride or 5% dextrose, ZERBAXA is stable for 24 hours when stored at room temperature or 7 days when stored under refrigeration at 2 to 8°C (36 to 46°F).
Constituted ZERBAXA solution or diluted ZERBAXA infusion should not be frozen.