Ceftaroline fosamil


Concise Prescribing Info
Indications/Uses
Listed in Dosage
Dosage/Direction for Use
Adult : IV Complicated skin and skin structure infections; Community-acquired pneumonia 600 mg 12 hrly.
Dosage Details
Intravenous
Community-acquired pneumonia, Complicated skin and skin structure infections
Adult: 600 mg 12 hrly via infusion over 60 min. Treatment duration: 5-14 days for complicated skin and skin structure infections (cSSSI); 5-7 days for community-acquired pneumonia (CAP). 
Child: 2 mth to <2 yr 8 mg/kg 8 hrly. 2-<12 yr 12 mg/kg (Max: 400 mg) 8 hrly. 12-<18 yr <33 kg: 12 mg/kg (Max: 400 mg) 8 hrly; ≥33 kg: Same as adult. All doses are given via infusion over 60 min. Treatment duration: 5-14 days for cSSSI; 5-7 days for CAP.
Renal Impairment
ESRD (including haemodialysis): 200 mg 12 hrly.

 CrCl (mL/min) Dosage
 15-30 300 mg 12 hrly.
 31-50 400 mg 12 hrly. 
Reconstitution
Add 20 mL of sterile water for inj to a vial containing 400 or 600 mg to provide a 20 or 30 mg/mL soln, respectively. Further dilute reconstituted soln in 50-250 mL (based on patient’s volume requirement) of compatible soln to a final concentration not exceeding 12 mg/mL. 
Contraindications
Hypersensitivity to cephalosporins, immediate and severe hypersensitivity to other β-lactam antibacterials (e.g. penicillins, carbapenems).
Special Precautions
Patient w/ history of non-severe hypersensitivity to other β-lactam antibacterials, seizure disorder. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Superinfections, seizures, risk of haemolytic anaemia.
Nervous: Headache, dizziness.
CV: Phlebitis.
GI: Diarrhoea, nausea, vomiting, constipation, abdominal pain.
Hepatic: Increased transaminases.
Endocrine: Hypokalaemia.
Dermatologic: Pruritus, rash.
Others: Pyrexia, infusion site reactions (e.g. erythema, pain).
Potentially Fatal: Hypersensitivity reactions, Clostridium difficile-associated diarrhoea.
IV/Parenteral: B
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor renal function and for signs of hypersensitivity reactions during first dose.
Lab Interference
False positive Coombs’ test.
Action
Description: Ceftaroline fosamil is a 5th generation cephalosporin. It is a prodrug metabolised into bioactive ceftaroline which inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) 1-3 and inhibiting cell wall biosynthesis thereby causing bacterial cell death. It has strong affinity to PBP2a (a modified PBP in MRSA) and PBP2x in S. pneumoniae.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 1 hr.
Distribution: Volume of distribution: 20.3 L. Plasma protein binding: Approx 20%.
Metabolism: Ceftaroline fosamil is metabolised in the plasma into ceftaroline by phosphatase enzymes. Ceftaroline is further metabolised via hydrolysis into ceftaroline M-1 (inactive).
Excretion: Mainly via urine (approx 88%, mainly as unchanged drug); faeces (approx 6%). Terminal elimination half-life: Approx 2.66 hr.
Chemical Structure

Chemical Structure Image
Ceftaroline fosamil

Source: National Center for Biotechnology Information. PubChem Database. Ceftaroline fosamil, CID=9852981, https://pubchem.ncbi.nlm.nih.gov/compound/Ceftaroline-fosamil (accessed on Jan. 21, 2020)

Storage
Store at 25°C. Reconstituted soln: Stable for 6 hr when stored at room temp or for 24 hr when stored between 2-8°C.
MIMS Class
ATC Classification
J01DI02 - ceftaroline fosamil ; Belongs to the class of other cephalosporins and penems. Used in the systemic treatment of infections.
References
Anon. Ceftaroline Fosamil. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/09/2017.

Buckingham R (ed). Ceftaroline Fosamil Acetate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2017.

Joint Formulary Committee. Ceftaroline Fosamil. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Ceftaroline Fosamil. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 04/09/2017.

Teflaro (Forest Laboratories, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/09/2017.

Disclaimer: This information is independently developed by MIMS based on Ceftaroline fosamil from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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