Description and Brand Names

US Brand Name

  1. Zerbaxa

Descriptions


Ceftolozane and tazobactam combination injection is used alone or in combination with metronidazole to treat complicated bacterial infections in many different parts of the body (eg, stomach, kidneys). It is also used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

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 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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ceftolozane and tazobactam combination 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 combination injection.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholera Vaccine, Live

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 or
  • Diarrhea—Use with caution. May make these conditions worse.
  • End-stage kidney disease or
  • 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 Use

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1 hour.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine. This is to make sure that the medicine is working properly and that the infection is cleared up completely. Blood and urine 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. 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

  1. Bloody urine
  2. blurred vision
  3. decreased frequency or amount of urine
  4. diarrhea
  5. dizziness
  6. fever
  7. headache
  8. increased thirst
  9. loss of appetite
  10. lower back or side pain
  11. nausea
  12. nervousness
  13. pounding in the ears
  14. slow or fast heartbeat
  15. swelling of the face, fingers, or lower legs
  16. trouble breathing
  17. unusual tiredness or weakness
  18. vomiting
  19. weight gain

Less common

  1. Confusion
  2. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  3. dry mouth
  4. fainting
  5. headache, sudden and severe
  6. irregular heartbeat
  7. mood changes
  8. muscle pain or cramps
  9. numbness or tingling in the hands, feet, or lips
  10. pale skin
  11. seizures
  12. skin rash
  13. stomach cramps
  14. sweating
  15. tenderness in the stomach area
  16. troubled breathing with exertion
  17. unusual bleeding or bruising
  18. watery or bloody diarrhea

Rare

  1. Anxiety
  2. bone pain
  3. burning feeling in the chest or stomach
  4. chest pain
  5. drowsiness
  6. dry mouth
  7. dry, red, hot, or irritated skin
  8. fast, pounding, or irregular heartbeat or pulse
  9. flushed, dry skin
  10. fruit-like breath odor
  11. increased hunger
  12. increased urination
  13. indigestion
  14. muscle spasms (tetany) or twitching
  15. seizures
  16. severe constipation
  17. severe vomiting
  18. stomach pain or upset
  19. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  20. thick, white, or curd-like vaginal discharge
  21. tightness in the chest
  22. trembling
  23. trouble thinking, speaking, or walking
  24. unexplained weight loss
  25. white patches in the mouth or throat or on the tongue

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:

Less common

  1. Constipation
  2. trouble sleeping

Rare

  1. Belching
  2. bloated or full feeling
  3. excess air or gas in the stomach or bowels
  4. heartburn
  5. passing gas

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.