Dosing & Uses
Dosage Forms & Strengths
injectable, powder for reconstitution
- 400mg/vial
- 600mg/vial
Community-Acquired Bacterial Pneumonia
Indicated for treatment of community-acquired bacterial pneumonia (CABP)
600 mg IV q12hr x5-7 days
Skin & Skin Structure Infections
Indicated for acute bacterial skin and skin structure infections (ABSSSI), including MRSA
600 mg IV q12hr x5-14 days
Dosage Modifications
Renal impairment
- CrCl 30-50 mL/min: 400 mg IV q12hr
- CrCl 15 to ≤30 mL/min: 300 mg IV q12hr
- ESRD (including hemodialysis): 200 mg IV q12hr
Dosing Considerations
Susceptible isolates
-
CABP
- Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli
-
ABSSSI
- Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca
Dosage Forms & Strengths
injectable, powder for reconstitution
- 400mg/vial
- 600mg/vial
Community-Acquired Bacterial Pneumonia
Indicated in children aged ≥2 months for treatment of community-acquired bacterial pneumonia (CABP)
2 months to <2 years: 8 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (≤33 kg): 12 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (>33 kg): 400 mg q8hr OR 600 mg q12hr IV x5-14 days
≥18 years: 600 mg IV q12hr x5-7 days
Skin & Skin Structure Infections
Indicated in pediatric patients (≥34 weeks gestation and at least 12 days postnatal age) for treatment of acute bacterial skin and skin structure infections (ABSSSI)
Birth to <2 months: 6 mg/kg IV q8hr x5-14 days
2 months to <2 years: 8 mg/kg IV q8hr x5-14 days
2 years to <18 years (≤33 kg): 12 mg/kg IV q8hr x5-14 days
2 years to <18 years (>33 kg): 400 mg q8hr OR 600 mg q12hr IV x5-14 days
≥18 years: 600 mg IV q12hr x5-14 days
Dosage Modifications
Renal impairment
- CrCl >50 mL/min/1.73 m2 (estimated by Schwartz equation): No dose adjustment required
- CrCl <50 mL/min/1.73 m2: Insufficient information to recommend dose
Dosing Considerations
Susceptible isolates
-
CABP
- Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli
-
ABSSSI
- Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- BCG intravesical live
ceftaroline decreases effects of BCG intravesical live by pharmacodynamic antagonism. Contraindicated. Contraindicated; wait until antibiotic treatment completed.
- typhoid vaccine live
ceftaroline decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Delay vaccine until 3 days after antibiotic course completed, or administer 3 days before antibiotic initiated.
Serious - Use Alternative (1)
- cholera vaccine
ceftaroline, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
Monitor Closely (3)
- dichlorphenamide
dichlorphenamide and ceftaroline both decrease serum potassium. Use Caution/Monitor.
- probenecid
probenecid increases levels of ceftaroline by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
ceftaroline decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.
Minor (12)
- alteplase
ceftaroline increases effects of alteplase by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- antithrombin III
ceftaroline increases effects of antithrombin III by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- argatroban
ceftaroline increases effects of argatroban by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- bivalirudin
ceftaroline increases effects of bivalirudin by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- dalteparin
ceftaroline increases effects of dalteparin by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- enoxaparin
ceftaroline increases effects of enoxaparin by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- fondaparinux
ceftaroline increases effects of fondaparinux by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- heparin
ceftaroline increases effects of heparin by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- pentosan polysulfate sodium
ceftaroline increases effects of pentosan polysulfate sodium by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- reteplase
ceftaroline increases effects of reteplase by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- tenecteplase
ceftaroline increases effects of tenecteplase by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- warfarin
ceftaroline increases effects of warfarin by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
Adverse Effects
1-10% (Adults)
Diarrhea (5%)
Nausea (4%)
Rash (3%)
Constipation (2%)
Vomiting (2%)
Increased transaminases (2%)
Hypokalemia (2%)
Phlebitis (2%)
<2%
- Blood and lymphatic system disorders: Anemia, eosinophilia, neutropenia, thrombocytopenia
- Cardiac disorders: Bradycardia, palpitations
- Gastrointestinal disorders: Abdominal pain
- General disorders and administration site conditions: Pyrexia
- Hepatobiliary disorders: Hepatitis
- Immune system disorders: Hypersensitivity, anaphylaxis
- Infections and infestations: Clostridium difficile colitis
- Metabolism and nutrition disorders: Hyperglycemia, hyperkalemia
- Nervous system disorders: Dizziness, convulsion
- Renal and urinary disorders: Renal failure
- Skin and subcutaneous tissue disorders: Urticaria
1-10% (Pediatrics)
Diarrhea (8%)
Rash (7%)
Vomiting (5%)
Nausea (3%)
Pyrexia (3%)
Increased ALT/AST (<3%)
Headache (<3%)
Pruritus (<3%)
Postmarketing Reports (Pediatrics)
Agranulocytosis
Leukopenia
Eosinophilic pneumonia
Encephalopathy, seizures
Warnings
Contraindications
Hypersensitivity to drug, excipients or other cephalosporins
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 patient (i.e. transfusion) if clinically indicated
Prescribing drug in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of 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 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 product is to be given to a penicillin-or other beta-lactam-allergic patient; cross sensitivity among beta-lactam antibacterial agents has been clearly 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 normal flora of colon and may permit overgrowth of C. difficile
- C. difficile produces toxins A and B which contribute to 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 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 & Lactation
Pregnancy
No data in pregnant women are available
Animal studies
- In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation
- In rabbits exposed to ceftaroline during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity
Lactation
No data are available regarding presence in human milk, or the effects on breastfed infants or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Beta-lactam cephalosporin with activity against aerobic and anaerobic gram-positive and aerobic gram-negative bacteria
Demonstrates activity in vivo against resistant methicillin-resistant Staphylococcus aureus (MRSA) strains and in vitro against vancomycin-resistant and linezolid-resistant S aureus
Absorption
Peak plasma concentration: 21.3 mcg/mL
Peak plasma time: 1 hr
Distribution
Vd: 20.3 L
Protein bound: 20%
Metabolism
Ceftaroline fosamil converted to bioactive ceftaroline in plasma by phosphatase enzyme; undergoes hydrolysis
Elimination
Clearance: 9.6 L/hr
Half-life: 2.6 hr
Excretion: urine (88%)
Administration
IV Compatibilities
Solution: 0.9% NaCl; D5W; 2.5% dextrose/0.45% NaCl; Lactated Ringer’s solution
IV Preparation
Reconstitute vial by adding 20 mL sterile water for injection, 0.9% NaCl, D5W, or lactated ringer’s injection; mix gently and ensure all powder has dissolved completely
Resulting approximate concentrations: 400 mg vial (20 mg/mL); 600 mg vial (30 mg/mL)
Color of solution ranges from clear to light-to-dark yellow depending on concentration and storage conditions
Dilution of reconstituted solution
- Withdraw total volume from vial and add to 50-250 mL of 0.9% NaCl, D5W, 2.5% dextrose/0.45% NaCl, or lactated ringer’s solution; use the same diluent that was used for reconstituting (unless sterile water for injection was used)
Dilution of the constituted solution in 50 mL infusion bags
- Preparation of 600 mg dose in (for adult patients): Withdraw 20 mL from bag before adding constituted drug; resulting concentration ~12 mg/mL
- Preparation of 400 mg dose (for adult and pediatric patients weighing >33 kg): Withdraw 20 mL from bag before adding constituted drug; resulting concentration ~8 mg/mL
-
Preparation for children weighing ≤33 kg
- Preparation of dose in infusion bag for pediatric patients weighing ≤33 kg: Amount of solution withdrawn from the constituted vial for dilution in the infusion bag will vary according to the weight and age of the child; infusion solution concentration should not exceed 12 mg/mL ceftaroline
IV Administration
Administer IV injection via volumetric infusion pump
Adults and children aged >2 months: Infuse over 5-60 minutes
Children aged <2 months: Infuse over 30-60 minutes
Storage
Unopened vials: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Stability of diluted drug in infusion bag or 50-mL bag
- Room temperature: 6 hr
- Refrigerated 2-8°C (36-46°F): 24 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Teflaro intravenous - | 400 mg vial |  | |
| Teflaro intravenous - | 600 mg vial |  | |
| Teflaro intravenous - | 400 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ceftaroline fosamil intravenous
CEFTAROLINE - INJECTION
(sef-TAR-oh-leen)
COMMON BRAND NAME(S): Teflaro
USES: Ceftaroline is an antibiotic used to treat a variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.
HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually every 8 or 12 hours. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on age and weight.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check the product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: Pain, redness, or swelling at the injection site may occur. Nausea or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion), seizures.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using ceftaroline, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.Ceftaroline may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant before using this medication.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain medical/laboratory tests (such as Coombs' test, urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Laboratory and/or medical tests (such as kidney function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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