Teflaro is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Teflaro is used to treat skin infections caused by bacteria in adults and newborns (at least 34 weeks gestational age and 12 days postnatal age).

Teflaro is also used to treat pneumonia caused by bacteria in adults and children 2 months of age and older.

You should not use Teflaro if you are allergic to ceftaroline or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others. Tell your doctor if you are allergic to any drugs, especially penicillins or other antibiotics.

Use Teflaro for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Teflaro will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using Teflaro and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Use Teflaro exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Teflaro is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Teflaro should look clear or yellow in color. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

This medicine must be given slowly, and the IV infusion can take up at least 1 hour to complete.

Teflaro injection must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine. Do not mix Teflaro in the same injection with other antibiotics.

Teflaro is sometimes given for up to 14 days. Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Teflaro will not treat a viral infection such as the flu or a common cold.

Store unmixed vials of Teflaro powder at room temperature, away from moisture and heat.

After mixing Teflaro injection with a diluent, you may store the mixture for up to 6 hours at room temperature, or up to 24 hours in a refrigerator. Do not freeze.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose of Teflaro for Pneumonia:

600 mg IV every 12 hours

Duration of therapy:
-Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
-Community-acquired bacterial pneumonia (CABP): 5 to 7 days

Uses:
-For the treatment of ABSSSI due to susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, and K oxytoca
-For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K pneumoniae, K oxytoca, and E coli

Usual Adult Dose of Teflaro for Skin and Structure Infection:

600 mg IV every 12 hours

Duration of therapy:
-Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
-Community-acquired bacterial pneumonia (CABP): 5 to 7 days

Uses:
-For the treatment of ABSSSI due to susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, and K oxytoca
-For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K pneumoniae, K oxytoca, and E coli

Usual Pediatric Dose of Teflaro for Skin and Structure Infection:

Less than 2 months (gestational age at least 34 weeks and postnatal age at least 12 days): 6 mg/kg IV every 8 hours
2 months to less than 2 years: 8 mg/kg IV every 8 hours
2 years to less than 18 years (up to 33 kg): 12 mg/kg IV every 8 hours
2 years to less than 18 years (greater than 33 kg): 400 mg IV every 8 hours OR 600 mg IV every 12 hours

Duration of therapy: 5 to 14 days

Comments:
-Drug levels in cerebrospinal fluid have not been evaluated in pediatric patients younger than 2 months.
-No information available for dosing this drug in infants less than 34 weeks gestational age and younger than 12 days postnatal age.

Use: For the treatment of ABSSSI due to susceptible isolates of S aureus (including methicillin-susceptible and -resistant isolates), S pyogenes, S agalactiae, E coli, K pneumoniae, and K oxytoca

Usual Pediatric Dose of Teflaro for Pneumonia:

2 months to less than 2 years: 8 mg/kg IV every 8 hours
2 years to less than 18 years (up to 33 kg): 12 mg/kg IV every 8 hours
2 years to less than 18 years (greater than 33 kg): 400 mg IV every 8 hours OR 600 mg IV every 12 hours

Duration of therapy: 5 to 14 days

Use: For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), H influenzae, K pneumoniae, K oxytoca, and E coli

To make sure Teflaro is safe for you, tell your doctor if you have:

• a seizure;

• an allergy to any drugs (especially penicillins);

• kidney disease (or if you are on dialysis); or

• intestinal problems, such as colitis.

Tell your doctor if you are pregnant or breastfeeding.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction to Teflaro: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• little or no urination;

• a seizure;

• drowsiness, tiredness, confusion, thinking problems;

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, muscle weakness or limp feeling; or

• low blood cell counts - sudden weakness or ill feeling, fever, chills, cold or flu symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common Teflaro side effects may include:

• nausea;

• diarrhea; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with ceftaroline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.