Ceftaroline fosamil parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for concentrate for solution for infusion containing 600mg ceftaroline fosamil
Drugs List
Therapeutic Indications
Uses
Community acquired pneumonia
Complicated skin and soft tissue infections
Dosage
The recommended duration of treatment for cSSTI = 5 to 14 days
The recommended duration of treatment for CAP = 5 to 7 days
Adults
600mg administered every 12 hours.
Children
12 to 18 year olds with bodyweight equal to or greater than 33kg
600mg administered every 12 hours.
12 years to 18 year olds with bodyweight less than 33kg
12mg/kg (maximum 400mg) administered every 8 hours.
2 years to less than 12 years old
12mg/kg (maximum 400mg) administered every 8 hours.
2 months to less than 2 years old
8mg/kg administered every 8 hours.
Birth to less than 2 months old
6mg/kg administered every 8 hours.
Patients with Renal Impairment
12 years and older with bodyweight equal to or greater than 33kg
Creatinine clearance greater than 50 ml per minute
No dose adjustment necessary.
Creatinine clearance greater than 30ml per minute to less than or equal to 50ml per minute
400mg administered every 12 hours.
Creatinine clearance greater than or equal to 15ml per minute to less than or equal to 30ml per minute
300mg administered every 12 hours.
End stage renal disease including haemodialysis
200mg administered every 12 hours. Ceftaroline is haemodialyzable and should be administered after haemodialysis on haemodialysis days.
12 years old to less than 18 years old with bodyweight less than 33kg
Creatinine clearance greater than 50 ml per minute
No dose adjustment necessary.
Creatinine clearance greater than 30ml per minute to less than or equal to 50ml per minute
8mg/kg (maximum 300mg) administered every 8 hours.
Creatinine clearance greater than or equal to 15ml per minute to less than or equal to 30ml per minute
6mg/kg (maximum 200mg) administered every 8 hours.
End stage renal disease including haemodialysis
Contraindicated.
2 years old to less than 12 years old
Creatinine clearance greater than 50ml per minute
No dose adjustment necessary.
Creatinine clearance greater than 30ml per minute to less than or equal to 50ml per minute
8mg/kg (maximum 300mg) administered every 8 hours.
Creatinine clearance greater than or equal to 15ml per minute to less than or equal to 30ml per minute
6mg/kg (maximum 200mg) administered every 8 hours.
End stage renal disease including haemodialysis
Contraindicated.
2 months to less than 2 years old
Creatinine clearance greater than 50ml per minute
No dose adjustment necessary.
Creatinine clearance less than or equal to 50ml per minute
Contraindicated.
End stage renal disease including haemodialysis
Contraindicated.
Administration
For intravenous infusion over 60 minutes only.
Contraindications
History of serious hypersensitivity reactions
Precautions and Warnings
Immunosuppression
Septic shock
Severe sepsis
Breastfeeding
Epileptic disorder
Haemodialysis
History of seizures
Pregnancy
Renal impairment - creatinine clearance below 50ml/minute
Renal impairment in children under 18 years
Severe pulmonary disease
Reduce dose in patients with creatinine clearance below 50ml/min
Advise patient dizziness may affect ability to drive or operate machinery
Consult national/regional policy on the use of anti-infectives
May reduce seizure threshold
Consider pseudomembranous colitis if patient presents with diarrhoea
Superinfection may occur during therapy
Test interference: May cause false positive Coombs test
May affect urinary glucose test for reducing substances
Discontinue if severe and persistent diarrhoea develops
Discontinue if severe hypersensitivity reactions occur
Serious and occasionally fatal hypersensitivity reactions are possible. Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil. Use with caution in patients with a history of any other type of hypersensitivity reaction to penicillins or carbapenems. If a severe allergic reaction occurs during treatment with ceftaroline fosamil, discontinue treatment and take appropriate measures.
Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline fosamil and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftaroline fosamil. In this circumstance consider discontinuing therapy with ceftaroline fosamil and use supportive measures together with the administration of specific treatment for clostridium difficile.
There is no experience with ceftaroline fosamil in the treatment of CAP in the following patient groups: the immunocompromised, patients with severe sepsis or septic shock, severe underlying lung disease, those with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillin-resistant S. aureus or patients requiring intensive care. Caution is advised when treating such patients.
There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: the immunocompromised, patients with severe sepsis or septic shock, necrotizing fasciitis, perirectal abscess and patients with third degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.
Pregnancy and Lactation
Pregnancy
Use ceftaroline fosamil with caution during pregnancy.
The manufacturer does not recommend using ceftaroline fosamil during pregnancy.
At the time of writing, there are limited data from the use of ceftaroline fosamil in pregnant women. Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations. Following administration throughout pregnancy in rats, there was no effect on pup birth weight or growth, although minor changes in foetal weight and delayed ossification of the interparietal bone were observed when ceftaroline fosamil was administered during organogenesis.
Lactation
Use ceftaroline fosamil with caution during breastfeeding.
The manufacturer advises that the patient either discontinues ceftaroline fosamil or discontinues breastfeeding. It is unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk.
Side Effects
Abdominal pain
Abnormal INR
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaemia
Anaphylaxis
Antibiotic-associated colitis
Clostridium difficile diarrhoea
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Encephalopathy
Eosinophilia
Eosinophilic pneumonia
Erythema at injection site
Haemolytic anaemia
Headache
Hypersensitivity reactions
Increase of liver transaminases
Increased partial thromboplastin time
Injection site reactions
Leucopenia
Local pain (injection site)
Nausea
Neutropenia
Phlebitis
Phlebitis (injection site)
Positive Coombs test
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Seizures
Serum creatinine increased
Stevens-Johnson syndrome
Superinfections
Swelling of lips and face
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vomiting
Effects on Laboratory Tests
Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia The development of a positive direct antiglobulin test (DAGT) (Coombs test) may occur during treatment with cephalosporins.
In clinical studies there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
However, the possibility that haemolytic anaemia may occur in association with cephalosporins including ceftaroline treatment cannot be ruled out.
Patients experiencing anaemia during or after treatment with ceftaroline should be investigated for this possibility.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2020
Reference Sources
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Zinforo 600mg powder for concentrate for solution for infusion. Pfizer Limited. Revised September 2020.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 May 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Ceftaroline Last revised: 03 December 2018
Last accessed: 11 May 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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