Zinforo

Zinforo

ceftaroline fosamil

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ceftaroline fosamil
Indications/Uses
Complicated skin & soft tissue infections (cSSTI) & community-acquired pneumonia (CAP) in neonates, infants, childn, adolescents & adults.
Dosage/Direction for Use
IV infusion cSSTI Adult & adolescent 12 to <18 yr weighing ≥33 kg 600 mg over 5-60 min every 12 hr for 5-14 days. CAP All doses given for 5-7 days. Adolescent 12 to <18 yr weighing <33 kg & childn ≥2 to <12 yr 12 mg/kg over 5-60 min every 8 hr. Max: 400 mg, ≥2 mth to <2 yr 8 mg/kg over 5-60 min every 8 hr, birth to <2 mth 6 mg/kg over 60 min every 8 hr. Confirmed or suspected cSSTI caused by S. aureus w/ minimal inhibitory conc (MIC) = 2 or 4 mg/L All doses given over 120 min every 8 hr for 5-14 days. Adult 600 mg, adolescent & childn ≥2 to <18 yr 12 mg/kg. Max: 600 mg, ≥2 mth to <2 yr 10 mg/kg. Confirmed or suspected cSSTI caused by S. aureus w/ MIC <2 mg/L 600 mg over 5-60 min every 12 hr. Renal impairment cSSTI All doses given over 5-60 min every 12 hr for 5-7 days. Adult & adolescent 12 to <18 yr weighing ≥33 kg w/ CrCl >30 to ≤50 mL/min 400 mg, ≥15 to ≤30 mL/min 300 mg, ESRD including haemodialysis 200 mg. CAP All doses given over 5-60 min every 8 hr for 5-7 days. Adolescent 12 to <18 yr weighing <33 kg & childn ≥2 to <12 yr w/ CrCl >30 to ≤50 mL/min 8 mg/kg. Max: 300 mg, ≥15 to ≤30 mL/min 6 mg/kg. Max: 200 mg. Confirmed or suspected cSSTI caused by S. aureus w/ MIC = 2 or 4 mg/L All doses given over 120 min every 8 hr for 5-14 days. Adult w/ CrCl >30 to ≤50 mL/min 400 mg, ≥15 to ≤30 mL/min 300 mg, ESRD including haemodialysis 200 mg. Adolescent & childn ≥2 to <18 yr w/ CrCl >30 to ≤50 mL/min 10 mg/kg. Max: 400 mg, ≥15 to ≤30 mL/min 8 mg/kg. Max: 300 mg.
Contraindications
Hypersensitivity to ceftaroline fosamil & other cephalosporins. Immediate & severe hypersensitivity (eg, anaphylactic reaction) to β-lactam antibiotics (eg, penicillins & carbapenems).
Special Precautions
Discontinue use if hypersensitivity & severe cutaneous adverse reactions eg, SJS, TEN, DRESS, acute generalised exanthematous pustulosis; Clostridium difficile-associated diarrhea occur. Patients w/ history of hypersensitivity to cephalosporins, penicillins or other β-lactam antibacterials; pre-existing seizure disorders. Antibacterial-associated & pseudomembranous colitis; superinfections. Development of +ve direct antiglobulin test during treatment. May affect ability to drive or operate machines. Pregnancy & lactation.
Adverse Reactions
+ve direct Coombs test. Headache, dizziness; phlebitis; diarrhoea, nausea, vomiting, abdominal pain; increased transaminases; rash, pruritus; infusion site reactions (erythema, phlebitis, pain), pyrexia.
MIMS Class
Cephalosporins
ATC Classification
J01DI02 - ceftaroline fosamil ; Belongs to the class of other cephalosporins and penems. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zinforo powd for infusion 600 mg
Packing/Price
10 × 1's
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