Ceftaroline

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Acute bacterial skin and skin structure infections caused by Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca
• Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (Including cases with concurrent bacteraemia), Staphyloccus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae and Escherichia coli

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to the cephalosporin class of antibacterials
• History of immediate and severe hypersensitivity to other beta-lactam antibacterials (e.g. penicillins or carbapenems)

Cautions

• History of non-severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g. penicillins or carbapenems)
• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment
• History of seizure disorders
• Immunocompromised patients  
• Severe sepsis/septic shock
• Severe underlying lung disease
• Patients with PORT Risk Class V, and/or community acquired pneumonia requiring ventilation at presentation
• Community acquired pneumonia due to methicillin-resistant S. aureus 
• Non-susceptible organisms
• Patients requiring intensive care
• Necrotizing fasciitis
• Perirectal abscess  
• Third degree and extensive burns
• Diabetic foot infections
• Diarrhoea
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

Infections caused by Gram-positive aerobic cocci (including Methicilin-resistant S. aureus); Gram-negative bacilli (excluding Enterobacteriaceae, Pseudomonas spp.); Limited anaerobic cover, including Peptostreptococcus

General dosing range

• IV: 600mg, 12hrly, over 1hr; Treatment duration: 5-14 days

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Acute bacterial skin and skin structure infections

• IV: 600mg, 12hrly, over 1hr; Treatment duration: 5-14 days

Community acquired bacterial pneumonia

• IV: 600mg, 12hrly, over 1hr; Treatment duration: 5-7 days

Not established for use in children in South Africa

Pregnancy

• Caution
• There are no or limited amount of 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, 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
• As a precautionary measure, it is preferable to avoid the use of  ceftaroline during pregnancy unless the clinical condition of the woman requires treatment with an antibiotic with ceftaroline's antibacterial profile

Breastfeeding

• Caution
• It is unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ceftaroline therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• The effects of ceftaroline on fertility on humans have not been studied. Animal studies with ceftaroline do not indicate harmful effects with respect to fertility

Renal Impairment

• CrCl >50ml/min: No dose adjustment recommended
• CrCl ≤50ml/min: Caution; dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness

Cardiovascular Disorders

• Phlebitis

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Abdominal pain
• Clostridium difficile colitis

Hepatobiliary Disorders

• Increased transaminases

Genitourinary Disorders

• Increased blood creatinine

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Infusion site reaction
• Infusion site erythema
• Infusion site pain
• Urticaria
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Acute generalised exanthematous pustulosis

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Leucopenia
• Neutropenia
• Thrombocytopenia
• Prolonged prothrombin time  
• Prolonged activated partial thromboplastin time  
• Increased international normalized ratio
• Agranulocytosis
• Eosinophilia and systemic symptoms
• Anaphylaxis
• Hypersensitivity
• Lip and face swelling
• Fever

No information available

None routine. Specific cases may require

• Renal function

Ceftaroline is a cephalosporin with in vitro activity against Gram-positive and Gram-negative bacteria. The bactericidal action of ceftaroline is mediated through inhibition of bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).

Spectrum of activity: Gram-positive aerobic cocci (including Methicilin-resistant S. aureus); Gram-negative bacilli (excluding Enterobacteriaceae, Pseudomonas spp.); Limited anaerobic cover, including Peptostreptococcus,

Injection (per vial) 600mg

• Zinforo (AstraZeneca) originator