Zerbaxa

Zerbaxa injection is used alone or in combination with metronidazole to treat bacterial infections in many different parts of the body.

Ceftolozane and tazobactam combination is an antibiotic that belongs to the group of medicines known as cephalosporins and beta-lactamase inhibitors.

It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor. This product is available in the following dosage forms:

• Powder for Solution

Before using Zerbaxa, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of ceftolozane and tazobactam injection in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ceftolozane and tazobactam injection in the elderly.

However, elderly patients are more likely to have unwanted effects and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving ceftolozane and tazobactam injection.

Pregnancy: All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to cephalosporins, beta-lactams, or penicillins, history of 
• Diarrhea—Use with caution. May make these conditions worse
• Kidney disease, moderate to severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body

Proper usage of Zerbaxa requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give you this medicine in a hospital.

This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 1 hour.

Before using Zerbaxa, there are some precautions you must take. Your doctor will check your progress closely while you are receiving this medicine. This is to make sure that the infection is cleared up completely. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Ceftolozane and tazobactam combination may cause diarrhea, and in some cases, it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor.

Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

As with many medications, there are several potential side effects associated with Zerbaxa. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More Common:

• Fever

Less Common:

• Blurred vision
• Confusion
• Convulsions
• Decreased urine
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Increased thirst
• Irregular heartbeat
• Loss of appetite
• Muscle pain or cramps
• Nausea or vomiting
• Numbness or tingling in the hands, feet, or lips
• Pale skin
• Rash
• Sweating
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Rare:

• Abdominal or stomach cramps or pain
• Arm, back, or jaw pain
• Bloating
• Bloody urine
• Chest pain or discomfort
• Chest tightness or heaviness
• Constipation
• Creamy white, curd-like patches in the mouth or throat
• Decreased frequency or amount of urine
• Diarrhea
• Dry, red, hot, or irritated skin
• Fast or irregular heartbeat
• Hives or welts, itching skin
• Increased thirst
• Lower back or side pain
• Pain when eating or swallowing
• Severe constipation
• Severe vomiting
• Swelling of the face, fingers, or lower legs
• Weight gain

Incidence Not Known:

• Abdominal or stomach tenderness
• Cough
• Difficulty with swallowing
• Dizziness
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Severe abdominal or stomach cramps and pain
• Watery and severe diarrhea, which may also be bloody

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common:

• Headache

Less Common:

• Acid or sour stomach
• Belching
• Burning feeling in the chest or stomach
• Fear or nervousness
• Heartburn
• Indigestion
• Stomach discomfort or upset
• Trouble sleeping

Rare:

• Flushed, dry skin
• Fruit-like breath odor
• Increased hunger
• Increased urination
• Unexplained weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.