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Ceftolozane and tazobactam (Intravenous route)

Pronunciation:

sef-TOL-oh-zane, taz-oh-BAK-tam

Brand Names:

  • Zerbaxa

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic

Antibiotic Combination

Pharmacologic

Cephalosporin

Uses of This Medicine:

Ceftolozane and tazobactam 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.

Before Using This Medicine:

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.

Children

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.

Older adults

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

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

Breast-feeding

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.

Other medicines

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.
  • 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 of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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
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.


Last Updated: 9/15/2016
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