Ceftaroline

Ceftaroline is a prescription medication used for the treatment of community-acquired bacterial pneumonia and skin and skin structure infections.

• Ceftaroline is available under the following different brand names: Teflaro

Adult and pediatric dosage

Injectable, powder for reconstitution

• 400mg/vial
• 600mg/vial

Community-Acquired Bacterial Pneumonia

Adult dosage

• 600 mg IV every 12 hours for 5-7 days

Pediatric dosage

• Children between 2 months to 1 year: 8 mg/kg IV every 8 hours for 5-14 days
• Children above 2 years and below 18 years (weighing less than 33 kg): 12 mg/kg IV every 8 hours for 5-14 days
• Children above 2 years and below 18 years (weighing above 33 kg): 400 mg every 8 hours OR 600 mg every 12 hours IV  for 5-14 days
• Children above 18 years: 600 mg IV every 12 hours for 5-7 days

Skin & Skin Structure Infections

Adult dosage

• 600 mg IV every 12 hours for 5-14 days

Pediatric dosage

• Newborns and children below 2 months: 6 mg/kg IV every 8 hours for 5-14 days
• Children between 2 months to 1 year: 8 mg/kg IV every 8 hours for 5-14 days
• Children between 2 years and 18 years (weighing below 33 kg): 12 mg/kg IV every 8 hours for 5-14 days
• Children between 2 years and 18 years (weighing above 33 kg): 400 mg every 8 hours OR 600 mg every 12 hours IV for 5-14 days
• Children above 18 years: 600 mg IV every 12 hours for 5-14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ceftaroline include:

• nausea,
• constipation,
• headache,
• vomiting,
• dizziness,
• drowsiness,
• fatigue,
• diarrhea,
• dry mouth,
• upper respiratory tract infection,
• anemia,
• abdominal pain,
• swelling of the extremities,
• fever,
• urinary tract infection,
• runny or stuffy nose,
• sinus infection,
• bronchitis,
• loss of appetite,
• muscle spasm,
• back pain,
• anxiety,
• insomnia,
• depression,
• sore throat,
• increased sweating,
• itching,
• rash,
• hot flashes, and
• high blood pressure.

Serious side effects of Ceftaroline include:

• severe stomach pain, 
• watery or bloody diarrhea (even if it occurs months after the 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.

Rare side effects of Ceftaroline include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ceftaroline has severe interactions with the following drugs:
  • BCG intravesical live
  • typhoid vaccine live
• Ceftaroline has serious interactions with the following drug:
  • cholera vaccine
• Ceftaroline has moderate interactions with the following drugs:
  • dichlorphenamide
  • probenecid
  • sodium picosulfate/magnesium oxide/anhydrous citric acid
• Ceftaroline has minor interactions with the following drugs:
  • alteplase
  • antithrombin III
  • argatroban
  • bivalirudin
  • dalteparin
  • enoxaparin
  • fondaparinux
  • heparin
  • pentosan polysulfate sodium
  • reteplase
  • tenecteplase
  • warfarin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to drug, excipients, or other cephalosporins

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ceftaroline?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ceftaroline?”

Cautions

• If anemia develops during or after treatment, consider drug-induced hemolytic anemia; perform diagnostic studies including a direct Coombs’ test; if drug-induced hemolytic anemia suspected, consider discontinuation; administer supportive care to the patient (i.e. transfusion) if clinically indicated
• Prescribing drugs in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
• Neurological adverse reactions reported during postmarketing surveillance in patients treated with cephalosporins; reactions include encephalopathy and seizures; most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment; if neurological adverse reactions occur, consider discontinuing therapy or making appropriate dosage adjustments in patients with renal impairment
• Hypersensitivity reactions
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions were reported in patients receiving beta-lactam antibacterial drugs
  • Before therapy is instituted, make careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems
  • Maintain clinical supervision if the product is to be given to a penicillin-or another beta-lactam-allergic patient; cross-sensitivity among beta-lactam antibacterial agents has been established; if allergic reaction occurs, discontinue therapy and institute appropriate treatment and supportive measures
  • Clostridium difficile-associated diarrhea (CDAD)
  • CDAD reported for nearly all systemic antibacterial agents and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile
  • C. difficile produces toxins A and B which contribute to the development of CDAD; hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy
  • CDAD must be considered in all patients who present with diarrhea following antibiotic use; careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents
  • If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible; institute appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation as clinically indicated

Pregnancy and Lactation

• No data on pregnant women are available
• Lactation
  • No data are available regarding the presence of human milk or the effects on breastfed infants or milk production.