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).

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ceftaroline injection to treat ABSSSI in children at least 34 weeks gestational age and 12 days and older, and to treat CABP in children 2 months of age and older. However, safety and efficacy have not been established in children younger than these age groups.

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.

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
• Warfarin

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, end stage or
• Kidney disease, moderate or severe—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 or your child this medicine. This medicine is given through a needle placed in one of your veins.

This medicine is usually given every 8 hours (for children) or 12 hours (for adults) for 5 to 14 days or until your body responds to the medicine. Each treatment usually takes 5 to 60 minutes.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you or your child 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 or your child's 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 or your child's 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 or your child have itching, hives, hoarseness, 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 or your child 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.

This medicine may cause brain or nerve problems (eg, encephalopathy and seizures). Check with your doctor right away if you have agitation, back pain, blurred vision, coma, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, shaking or jerking of one area or side of the body, stiff neck, unusual tiredness or weakness, or vomiting.

Hemolytic anemia may occur while you are using this medicine. Check with your doctor right away if you or your child 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 or your child 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

Black, tarry stools

blood in the urine or stools

bluish color

changes in skin color

chest pain, discomfort, or tightness

confusion

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

increased blood pressure

increased thirst

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

seizures

skin itching, rash, redness, or hives

slow or irregular heartbeat

sores, ulcers, or white spots on the lips or in the mouth

stomach cramps, pain, or tenderness

swelling of the face, throat, fingers, or lower legs

swollen glands

trouble breathing

unusual bleeding or bruising

watery and severe diarrhea, which may also be bloody

weakness or heaviness of the legs

weight gain

Incidence not known

Agitation

back pain

blurred vision

coma

hallucinations

irritability

mood or mental changes

shaking or jerking of one area or side of the body

stiff neck

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

Difficulty having a bowel movement (stool)

flushed, dry skin fruit-like breath odor

increased hunger

increased urination

sweating

unexplained weight loss

welts

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.