Zinforo

Zinforo

ceftaroline fosamil

Manufacturer:

Pfizer

Distributor:

Pfizer
Concise Prescribing Info
Contents
Ceftaroline fosamil
Indications/Uses
Adult, adolescent & childn >2 mth w/ complicated skin & soft tissue infections (cSSTI) & community-acquired pneumonia (CAP).
Dosage/Direction for Use
IV infusion Adult & adolescent 12 to <18 yr weighing ≥33 kg 600 mg every 12 hr over 5-60 min. Treatment of cSSTI confirmed or suspected to be caused by Staph aureus w/ MIC <2 mg/L 600 mg every 12 hr over 5-60 min. Treatment of adult w/ cSSTI confirmed or suspected to be caused by Staph aureus w/ 2-4 mg/L MIC 600 mg every 8 hr over 120 min. Adolescent 12 yr to <18 yr w/ cSSTI 600 mg every 12 hr over 5-60 min for 5-14 days; cSSTI in adult when caused by Staph aureus w/ 2-4 mg/L MIC 600 mg every 8 hr over 120 min for 5-14 days; CAP 600 mg every 12 hr over 5-60 min for 5-7 days. Childn ≥12 yr to <18 yr 12 mg/kg every 8 hr over 5-60 min; ≥2 yr to <12 yr 12 mg/kg every 8 hr over 5-60 min; ≥2 mth to <2 yr 8 mg/kg every 8 hr over 5-60 min. Renal impairment in adult & adolescent 12 yr to <18 yr w/ CrCl >30 to ≤50 mL/min 400 mg every 12 hr over 5-60 min (cSSTI & CAP), 400 mg every 8 hr over 120 min (cSSTI caused by Staph aureus w/ MIC 2-4 mg/L); ≥15 to ≤30 mL/min 300 mg every 12 hr over 5-60 min (cSSTI & CAP), 300 mg every 8 hr over 120 min (cSSTI caused by Staph aureus w/ MIC 2-4 mg/L); ESRD including hemodialysis 200 mg every 12 hr over 5-60 min (cSSTI & CAP), 200 mg every 8 hr over 120 min (cSSTI caused by Staph aureus w/ MIC 2-4 mg/L). Renal impairment in childn ≥12 yr to <18 yr & ≥2 yr to <12 yr w/ CrCl >30 to ≤50 mL/min 8 mg/kg every 8 hr over 5-60 min; ≥12 yr to <18 yr & ≥2 yr to <12 yr w/ CrCl ≥15 to ≤30 mL/min 6 mg/kg every 8 hr over 5-60 min.
Contraindications
Hypersensitivity to ceftaroline fosamil & other cephalosporins. Immediate & severe hypersensitivity (eg, anaphylactic reaction) to β-lactam antibiotics (eg, penicillins & carbapenems).
Special Precautions
Hypersensitivity reactions, severe cutaneous adverse reactions (SCARs) are possible. Discontinue if severe allergic reaction occurs. C. difficile-associated diarrhea. Preexisting seizure disorder. Development of +ve direct antiglobulin test. cSSTI caused by MRSA w/ an MIC >1 mg/L to ceftaroline. Superinfections. May affect ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
+ve Coombs' direct test. Headache, dizziness; phlebitis; diarrhea, nausea, vomiting, abdominal pain; increased transaminases; rash, pruritus; infusion site reactions (erythema, 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 inj (conc) 600 mg
Packing/Price
20 mL x 1's
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