ceftolozane/tazobactam (Rx)

Brand and Other Names:Zerbaxa
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ceftolozane/tazobactam

powder for reconstitution, IV

  • 1.5g/vial (ie, 1.5g = 1g ceftolozone plus 0.5g tazobactam)
  • Dose is based on the sum of the ingredients
more...

Complicated Intra-abdominal Infections

Indicated for use in combination with metronidazole for complicated intra-abdominal infections cause by Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius

1.5 g IV q8hr x4-14 days

Complicated Urinary Tract Infections

Indicated for complicated urinary tract infections, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa

1.5 g IV q8hr x7 days

Dosage Modifications

Hepatic impairment: No dosage adjustment required

Renal impairment

  • CrCl 30-50 mL/min: 750 mg (500 mg/250 mg) IV q8hr
  • CrCl 15-29 mL/min: 375 mg (250 mg/125 mg) IV q8hr
  • ESRD on hemodialysis: Administer a single loading dose of 750 mg (500 mg/250 mg) followed by a 150-mg (100 mg/50 mg) maintenance dose administered q8hr for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)

Safety and efficacy not established

Next:

Adverse Effects

1-10%

Nausea (2.8-7.9%)

Headache (2.5-5.8%)

Diarrhea (1.9-6.2%)

Pyrexia (1.7-5.6%)

Constipation (1.9-3.9%)

Insomnia (1.3-3.5%)

Vomiting (1.1-3.3%)

Hypokalemia (0.8-3.3%)

ALT increased (1.7-1.5%)

AST increased (1-1.7%)

Anemia (0.4-1.5%)

Thrombocytosis (0.4-1.9%)

Abdominal pain (0.8-1.2%)

Anxiety (0.2-1.9%)

Dizziness (0.8-1.1%)

Hypotension (0.4-1.7%)

Atrial fibrillation (0.2-1.2%)

Rash (0.9-1.7%)

<1%

Cardiac disorders: Tachycardia, angina pectoris

Gastrointestinal disorders: Ileus, gastritis, abdominal distension, dyspepsia, flatulence, paralytic ileus

General disorders and administration site conditions: Infusion site reactions

Infections and infestations: Candidiasis candidiasis (including oropharyngeal and vulvovaginal), fungal urinary tract infection

Investigations: Increased serum gamma-glutamyl transpeptidase (GGT), increased serum alkaline phosphatase, positive Coombs test

Metabolism and nutrition disorders: Hyperglycemia, hypomagnesemia, hypophosphatemia

Nervous system disorders: Ischemic stroke

Renal and urinary system: Renal impairment, renal failure

Respiratory, thoracic, and mediastinal disorders: Dyspnea

Skin and subcutaneous tissue disorders: Urticaria

Vascular disorders: Venous thrombosis

Previous
Next:

Warnings

Contraindications

Hypersensitivity to any of the components

Cautions

Clinical cure rates lower in patients with baseline CrCl of 30 to ≤50 mL/min when compared with other antibiotics in clinical trials

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported with beta-lactam antibacterial agents

As with all antibiotics, Clostridium difficile-associated diarrhea (CDAD) has been reported; if suspected, discontinue and initiate prompt treatment for CDAD

Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria

Previous
Next:

Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

more...
Previous
Next:

Pharmacology

Mechanism of Action

Ceftolozane: Cephalosporin that has demonstrated potent in vitro activity against Pseudomonas aeruginosa

Tazobactam: Beta-lactamase inhibitor

Absorption

Day 1 measurements

Peak plasma time: 1.02 hr

Peak plasma concentration: 69.1/18.4 mcg/mL

AUC: 172/24.4 mcg•h/mL

Distribution

Protein bound: 16-21/30%

Vd: 13.5/18.2 L

Metabolism

Ceftolozane: Not metabolized to any appreciable extent

Tazobactam: The beta-lactam ring is hydrolyzed to form the pharmacologically inactive tazobactam metabolite M1

Elimination

Half-life: 2.77/0.91 hr

Renal clearance (ceftolozane): 3.41-5.59 L/hr

Excretion

  • Ceftolozane: >95% excreted unchanged in urine
  • Tazobactam: >80% excreted as the parent compound with the remainder excreted as the M1 metabolite
Previous
Next:

Administration

IV Compatibilities

Not established

IV Preparation

Reconstitute vial with 10 mL of sterile water for injection or 10 mL 0.9% NaCl and gently shake to dissolve

Final volume is ~11.4 mL

Must be further diluted; reconstituted solution is NOT for direct injection

Withdraw appropriate volume for dose (see list below) and add to 100 mL of 0.9% NaCl or D5W

Inspect for particulate matter and discoloration; color ranges from clear, colorless solutions to solutions that are clear and slightly yellow

Dose volume

  • 1.5 g (1 g/0.5 g): 11.4 mL (entire vial contents)
  • 750 mg (500 mg/250 mg): 5.7 mL
  • 375 mg (250 mg/125 mg): 2.9 mL
  • 150 mg (100 mg/50 mg): 1.2 mL

IV Administration

Infuse IV over 1 hr

Storage

Unreconstituted vials: Store refrigerated 2-8°C (36-46°F); protect from light

Reconstituted vials: May keep at room temperature for 1 hr before transfer and dilution in infusion bag

Diluted solution (IV bag): Stable for 24 hr when stored at room temperature or 7 days when refrigerated at 2-8°C (36-46°F)

Do not freeze

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous