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Ceftaroline (Intravenous route)

Pronunciation:

sef-TAR-oh-leen FOS-a-mil

Brand Names:

  • Teflaro

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

5th Generation Cephalosporin

Uses of This Medicine:

Ceftaroline injection is used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by bacteria in adult patients.

Ceftaroline injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

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

  • Anemia or
  • Colitis (inflammation in gut), history of or
  • Diarrhea, severe, history of—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of 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. This medicine is given through a needle placed in one of your veins.

This medicine is usually given every 12 hours for 5 to 14 days or until your body responds to the medicine. Each treatment usually takes at least an hour.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must receive this medicine on a regular schedule.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

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

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Hemolytic anemia may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty with breathing; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; unusual tiredness or weakness; or yellowing of the eyes or skin.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

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
Back, leg, or stomach pains
bleeding gums
chills
dark urine
difficulty with breathing
fever
general body swelling
headache
loss of appetite
nausea or vomiting
nosebleeds
pale skin
sore throat
unusual tiredness or weakness
yellowing of the eyes or skin
Less common
Abdominal or stomach tenderness
black, tarry stools
blood in the urine or stools
bluish color
changes in skin color
chest pain or discomfort
confusion
convulsions
cough
decreased frequency or amount of urine
diarrhea
difficulty with swallowing
dizziness
dry mouth
fast, irregular, pounding, or racing heartbeat or pulse
general tiredness and weakness
hives
increased blood pressure
increased thirst
itching
light-colored stools
lightheadedness, dizziness, or fainting
lower back or side pain
mood changes
muscle pain or cramps
nervousness
numbness or tingling in the hands, feet, or lips
painful or difficult urination
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
severe abdominal or stomach cramps and pain
shortness of breath
skin itching, rash, or redness
slow or irregular heartbeat
sores, ulcers, or white spots on the lips or in the mouth
swelling of the face, throat, fingers, or lower legs
swollen glands
tenderness
tightness in the chest
troubled breathing
troubled breathing with exertion
unusual bleeding or bruising
upper right abdominal or stomach pain
watery and severe diarrhea, which may also be bloody
weakness or heaviness of the legs
weight gain
wheezing

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
Blurred vision
difficulty having a bowel movement (stool)
flushed, dry skin fruit-like breath odor
hives or welts
increased hunger
increased urination
sweating
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: 4/4/2014

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