Zinforo IV Infusion 600mg/vial

Ceftaroline is a cephalosporin with activity against Gram-positive and Gram-negative bacteria. In vitro studies have shown that ceftaroline is bactericidal, due to inhibition of bacterial cell wall synthesis by binding to penicillin binding proteins (PBPs). Ceftaroline is also active against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-nonsusceptible Streptococcus pneumoniae (PNSP) due to its affinity for the altered PBPs found in these organisms.

The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.

Indications	Age Range	Dosage	Infusion Time	Duration
Acute Bacterial Skin and Skin Structure Infections	18 years and older	600 mg every 12 hours	5 to 60 minutes	5 to 14 days
	≥2 years to <18 years (>33 kg)	600 mg every 12 hours	5 to 60 minutes	5 to 14 days
	≥2 years to <18 years (≤33kg)	12 mg/kg every 8 hours	5 to 60 minutes	5 to 14 days
	2 months to <2 years	8 mg/kg every 8 hours	5 to 60 minutes	5 to 14 days
	0 to <2 months	6 mg/kg every 8 hours	30 to 60 minutes	5 to 14 days
Community Acquired Bacterial Pneumonia	18 years and older	600 mg every 12 hours	5 to 60 minutes	5 to 14 days
	≥2 years to <18 years (>33 kg)	600 mg every 12 hours	5 to 60 minutes	5 to 14 days
	≥2 years to <18 years (≤33kg)	12 mg/kg every 8 hours	5 to 60 minutes	5 to 14 days
	2 months to <2 years	8 mg/kg every 8 hours	5 to 60 minutes	5 to 14 days

No clinical drug-drug interaction studies have been conducted with Zinforo. There is minimal potential for drug-drug interactions between Zinforo and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

• Hypersensitivity to the active substance or to any of its excipients.
• Hypersensitivity to the cephalosporin class of antibacterials.
• Immediate and severe hypersensitivity (e.g., anaphylactic reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).

The common side effects include diarrhea, nausea, vomiting, abdominal pain, headache, dizziness, rash, pruritus, increased transaminases, phlebitis, pyrexia and infusion site reactions (erythema, phlebitis, pain). The uncommon side effects are anemia, leucopenia, thrombocytopenia, hypersensitivity/anaphylaxis, urticaria, Clostridium difficile colitis, prolonged prothrombin time, increased blood creatinine; and rarely eosinophilia.

No clinical data on pregnancy is available for Ceftaroline. Animal studies with Ceftaroline fosamil do not indicate harmful effects with respect to fertility, pregnancy, parturition or postnatal development. Ceftaroline should not be used during pregnancy unless clearly necessary and only if the potential benefit outweighs the possible risk. It is not known whether Ceftaroline is excreted in human milk, but because many beta-lactams are excreted in breast milk, women who are breast-feeding should be treated with Ceftaroline only if clearly indicated. Interruption of breast-feeding is recommended.

Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Zinforo. If a hypersensitivity reaction occurs, discontinue Zinforo. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Zinforo. Evaluate if diarrhea occurs.

Neurological adverse reactions have been reported in patients treated with cephalosporins, including Zinforo. If neurological adverse reactions occur, consider discontinuing Zinforo or making appropriate dosage adjustments in patients with renal impairment.

If anemia develops during or after therapy, a diagnostic workup for drug-induced hemolytic anemia should be performed and consideration given to discontinuation of Zinforo.

Use in pediatric patients: Safety and effectiveness of Zinforo in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. Safety and effectiveness of Zinforo in pediatric patients below the age of 2 months for the treatment of CABP have not been established as no data are available.

Renal Impairment: Dosage adjustment is required in adult patients with moderate (CrCl >30 to ≤50 ml/min) or severe (CrCl ≥15 to ≤30 ml/min) renal impairment and in patients with end-stage renal disease (ESRD – defined as CrCl<15 ml/min), including patients on hemodialysis (HD). There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl <50 ml/min.

Hepatic Insufficiency: The pharmacokinetics of Zinforo in patients with hepatic impairment have not been established. As Zinforo does not appear to undergo significant hepatic metabolism, the systemic clearance of Zinforo is not expected to be significantly affected by hepatic impairment.

Zinforo overdosage has occurred in patients with renal impairment. Reactions have included neurological sequelae, including encephalopathy. In the event of overdose, Zinforo should be discontinued and general supportive treatment given.