Zerbaxa - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Intraabdominal Infection, Urinary Tract Infection|
|Class:||Beta-lactamase inhibitors, Cephalosporins|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||ceftolozane, tazobactam, citric acid, L-arginine, and sodium chloride|
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ceftolozane and tazobactam
What is Zerbaxa Used For
ZERBAXA is used by healthcare professionals to treat complicated infections within the abdominal cavity and urinary tract infections, including a condition called “pyelonephritis” (a type of urinary tract infection that affects one or both kidneys) in adults.
Antibacterial drugs , including ZERBAXA, should only be used to treat bacterial infections. They do not treat viral infections (e.g. the common cold). Although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed and should not be shared. Skipping doses or not completing the full course of therapy may lead to development of resistant bacteria. Incorrect use of ZERBAXA may increase the likelihood that bacteria will develop resistance and will not be treatable by ZERBAXA or other antibacterials in the future.
How Does Zerbaxa Work
ZERBAXA contains 2 active substances. Ceftolozane prevents the growth of the bacterial cell wall and tazobactam binds to bacterial enzymes ( e.g. beta-lactamases) that breakdown the antibiotics. Both work together to kill bacteria and reduce the infection.
What are the Ingredients in Zerbaxa
Medicinal ingredients: ceftolozane 1 g (as ceftolozane sulfate) and tazobactam 0.5 g (as tazobactam sodium) per vial.
Non-medicinal ingredients: citric acid, L-arginine, and sodium chloride
ZERBAXA comes in the following dosage forms:
ZERBAXA is available as a lyophilized powder injection for intravenous use.
Do not use ZERBAXA if you are hypersensitive (allergic) to:
- this drug or to any ingredient listed above.
- antibiotics like penicillin, or medicines known as “cephalosporins”, or other beta-lactams.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZERBAXA. Talk about any health conditions or problems you may have, including if you:
- know you are, or have previously been hypersensitive to penicillins, cephalosporins, beta-lactamases, or other antibacterial medicines.
- have recently had diarrhea, or have had diarrhea before taking this medicine.
- have liver or kidney problems.
- are pregnant or planning to become pregnant. If you think you may be pregnant or are planning to have a baby, ask your healthcare professional or pharmacist for advice before taking this medicine.
- are breast-feeding or planning to breastfeed.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ZERBAXA:
- Probenecid (a drug used to treat gout)
Serious Warnings and Precautions
Severe and sometimes fatal allergic reactions (e.g. anaphylaxis) have occurred with beta-lactam antibiotics. Tell your doctor if you are allergic to antibacterial drugs such as penicillins, cephalosporin or carbapenem. If you have a severe allergic reaction, stop taking ZERBAXA and get immediate medical attention (See What are the possible side effects).
How to Take Zerbaxa
The usual total daily dose of ZERBAXA for adults is 1.5 g (1 g ceftolozane and 0.5 gtazobactam) administered every 8 hours by intravenous (IV) infusion over 1 hour, administered by the healthcare professional.
If you have kidney problems, your dose may be reduced.
|If you think you have taken too much ZERBAXA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
ZERBAXA is usually administered by a healthcare professional. If you suspect a missed dose, talk to your healthcare professional.
What are Possible Side Effects From Using Zerbaxa
Like all medicines, ZERBAXA may have side effects. The most common side effects are:
- Increase in the number of certain types of blood cells known as platelets
- Decrease in potassium (from blood tests)
- Atrial fibrillation (abnormal heart rhythm)
- Decrease in blood pressure
- Abdominal pain (stomach ache)
- Fever (high temperature)
- Increased liver enzymes (from blood tests)
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking ZERBAXA and contact your healthcare professional immediately.
These are not all the possible side effects you may feel when taking ZERBAXA. If you experience any side effects not listed here, contact your healthcare professional.
Serious Side Effects and What to do About Them
|Symptom / effect||Talk to your healthcare professional||Stop taking drug and get immediate medical help|
|Only if severe||In all cases|
Allergic Reaction: rash, hives (skin eruptions), swelling of the face, lips, tongue or throat, difficulty swallowing or breathing,
|Liver Disorder: yellowing of the skin or eyes, dark urine, pale stools||✓|
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Unopened vials: Store in a refrigerator (2°C – 8°C/36 - 46°F).
Store in the original package in order to protect from light.
Keep out of reach and sight of children.
If you want more information about Zerbaxa
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website or Merck Canada website merck.ca or by calling Merck Canada at 1-800-567-2594.
To report an adverse event related to ZERBAXA, please contact 1-800-567-2594.