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 adults, adolescents, childn, infants & neonates.
Dosage/Direction for Use
IV Recommended treatment duration: 5-14 days (for cSSTI) & 5-7 days (for CAP). cSSTI & CAP Adult & adolescent 12 to <18 yr (≥33 kg) 600 mg every 12 hr over 5-60 min infusion, adolescent 12 to <18 yr (<33 kg) & childn ≥2 to <12 yr 12 mg/kg every 8 hr over 5-60 min infusion (max: 400 mg), infant ≥2 mth to <2 yr 8 mg/kg every 8 hr over 5-60 min infusion, neonate from birth to <2 mth 6 mg/kg every 8 hr over 60-min infusion. Renal impairment: Adult w/ CrCl >30 to ≤50 mL/min 400 mg every 12 hr over 5-60 min infusion, ≥15 to ≤30 mL/min 300 mg every 12 hr over 5-60 min infusion, ESRD including haemodialysis 200 mg every 12 hr over 5-60 min infusion. Adolescent 12 to <18 yr (≥33 kg) w/ CrCl >30 to ≤50 mL/min 400 mg every 12 hr over 5-60 min infusion, ≥15 to ≤30 mL/min 300 mg every 12 hr over 5-60 min infusion, ESRD including haemodialysis 200 mg every 12 hr over 5-60 min infusion. Adolescent 12 to <18 yr (<33 kg) & childn ≥2 to <12 yr w/ CrCl >30 to ≤50 mL/min 8 mg/kg every 8 hr over 5-60 min infusion (max: 300 mg), ≥15 to ≤30 mL/min 6 mg/kg every 8 hr over 5-60 min infusion (max: 200 mg).
Contraindications
Hypersensitivity to ceftaroline fosamil or cephalosporins. Immediate & severe hypersensitivity (eg, anaphylactic reaction) to β-lactams (eg, penicillins or carbapenems).
Special Precautions
Possible serious & occasionally fatal hypersensitivity reactions; severe cutaneous AR (SCARs) eg, SJS, TEN, DRESS, acute generalised exanthematous pustulosis; discontinue & take appropriate measures if severe allergic reaction or SCAR occurs. Antibacterial-associated & pseudomembranous colitis, & superinfection to non-susceptible organisms may occur. Patients w/ pre-existing seizure disorder. Development of +ve direct antiglobulin test may occur during treatment. cSSTI caused by S. aureus w/ a MIC >1 mg/L; should not be used if MIC is >4 mg/L. May affect ability to drive & use machines. ESRD (in adolescents 12 to <18 yr w/ body wt <33 kg & childn 2-12 yr); moderate to severe renal impairment or ESRD (in paed <2 yr). Pregnancy. Interruption of breastfeeding is recommended. Paed <2 mth.
Adverse Reactions
+ve Coombs direct test. Diarrhoea, nausea, vomiting, abdominal pain; headache, dizziness; rash, pruritus; increased transaminases; phlebitis; pyrexia, infusion site reactions (erythema, phlebitis, pain).
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 conc for soln for infusion 600 mg
Packing/Price
10 × 1's
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