ceftolozane/tazobactam (Rx)

Brand and Other Names:Zerbaxa
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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

Complicated Intra-abdominal Infections

Indicated for use in combination with metronidazole for complicated intra-abdominal infections (cIAI) 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 (cUTI), including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa

1.5 g IV q8hr x7 days

Bacterial Pneumonia

Indicated for treatment of 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

3 g IV q8hr x8-14 days

Dosage Modifications

Hepatic impairment: No dosage adjustment required

Renal impairment

  • cIAI or cUTI
    • 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)
  • HABP/VABP
    • CrCl 30-50 mL/min: 1.5 g (1 g/0.5 g) IV q8hr
    • CrCl 15-29 mL/min: 750 mg (500 mg/250 mg) IV q8hr
    • ESRD on hemodialysis: Administer a single loading dose of 2.25 g (1.5 g/0.75 g) followed by a 450-mg (300 mg/150 mg) maintenance dose administered q8hr for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following dialysis completion)

<18 years: Safety and efficacy not established

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Adverse Effects

>10% (HABP/VABP)

Increased hepatic transaminase (11.9%)

1-10% (cIAI or cUTI)

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%)

1-10% (HABP/VABP)

Renal impairment/failure (8.9%)

Diarrhea (6.4%)

Intracranial hemorrhage (4.4%)

Vomiting (3.3%)

Clostridium difficile colitis (2.8%)

<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

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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

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Pregnancy & Lactation

Pregnancy

There are no data available on ceftolozane/tazobactam or its individual components regarding use in pregnant women to assess drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

Human data: Although available studies with multiple cephalosporins cannot definitively establish absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association of cephalosporin use during pregnancy with major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Lactation

There are no data on presence of either drug component in human milk; there are no data on effects of either drug component on breastfed infant, or on milk production

Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal conditions

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.

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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: 65.7/17.8 mcg/mL (cIAI, cUTI); 105/26.4 mcg/mL (HABP/VABP)

AUC: 186/35.8 mcg•h/mL (cIAI, cUTI); 392/73.3 mcg•h/mL (HABP/VABP)

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
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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

  • 3 g (2 g/1 g): 2 vials of 11.4 mL each (entire contents from 2 vials)
  • 2.25 g (1.5 g/0.5 g): 11.4 mL from 1 vial (entire contents) and 5.7 mL from a second vial
  • 1.5 g (1 g/0.5 g): 11.4 mL (entire vial contents)
  • 750 mg (500 mg/250 mg): 5.7 mL
  • 450 mg (300 mg/150 mg): 3.5 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

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Images

No images available for this drug.
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Patient Handout

Patient Education
ceftolozane-tazobactam intravenous

CEFTOLOZANE/TAZOBACTAM - INJECTION

(sef-TOL-oh-zane/TAZ-oh-BAK-tam)

COMMON BRAND NAME(S): Zerbaxa

USES: Ceftolozane/tazobactam is used to treat a variety of bacterial infections. It is a cephalosporin antibiotic. It works by stopping the growth of bacteria.

HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. It should be injected slowly over 1 hour. The dosage is based on your medical condition and response to treatment.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Pain, redness, or irritation at the injection site may occur. Nausea, diarrhea, or headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: muscle cramps, weakness, fast/slow/irregular heartbeat, signs of kidney problems (such as change in the amount of urine).Get medical help right away if you have any very serious side effects, including: confusion, trouble speaking.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ceftolozane/tazobactam, tell your doctor or pharmacist if you are allergic to it; or to cephalosporins, penicillins, or other antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as congestive heart failure, high blood pressure).Ceftolozane/tazobactam may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain laboratory tests (including certain urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Laboratory and/or medical tests (such as complete blood count, kidney function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised October 2020. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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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.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.