Zinforo Powder

1. INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used onl …

• DOSAGE AND ADMINISTRATION Dosage of Ceftaroline Fosamil for Injection by Indication in Adult and Pediatric Patients Indication Age Range Dosage Infusion Time Duration Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to 30 to ≤ 50 400 mg IV (over 5 to 60 minutes) every 12 hours ≥ 15 to ≤ 30 300 mg IV (over 5 to 60 minutes) every 12 hours End-stage renal disease, including hemodialysis b 200 mg IV (over 5 to 60 minutes) every 12 hours c a Creatinine clearance (CrCl) estimated using the Cockcroft-Gault formula. b End-stage renal disease is defined as CrCl < 15 mL/min. c Ceftaroline fosamil for injection is hemodialyzable; thus, ceftaroline fosamil for injection should be administered after hemodialysis on hemodialysis days
• Pediatrics : No dosage adjustment is required
• In pediatric patients with CrCL > 50 mL/min/1.73 m 2 , estimated using the Schwartz equation
• There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m 2
• Preparation of Ceftaroline Fosamil for Injection for Administration Constitution of Ceftaroline Fosamil for Injection Powder for Injection Aseptic technique must be followed in preparing the infusion solution. …

3. DOSAGE FORMS AND STRENGTHS For Injection: Ceftaroline fosamil for injection is supplied as 600 mg or 400 mg of sterile ceftaroline fosamil (equivalent to 653 mg and 435 mg, respectively, of ceftaroline fosamil monoacetate) powder in single-dose, 20 mL clear glass vials. The powder is constituted and further diluted for intravenous injection. …

• The safety and effectiveness of ceftaroline fosamil for injection in the treatment of ABSSSI have been established
• In pediatric patients (at least 34 weeks gestational age and 12 days postnatal age)
• The safety and effectiveness of ceftaroline fosamil for injection in the treatment of CABP have been established in the age groups 2 months to less than 18 years old. …

Of the 1,300 adult patients treated with ceftaroline fosamil for injection in the Phase 3 ABSSSI and CABP trials, 397 (30.5%) were ≥ 65 years of age. The clinical cure rates in the ceftaroline fosamil for injection group (Clinically Evaluable [CE] Population) were similar in patients ≥ 65 years of age compared with patients < 65 years of age in both the ABSSSI and CABP trials. …

• PATIENT COUNSELING INFORMATION Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment
• They should inform their healthcare provider about any previous hypersensitivity reactions to ceftaroline fosamil for injection, other beta-lactams (including cephalosporins) or other allergens
• Advise patients that neurological adverse reactions could occur with ceftaroline fosamil for injection use. …

• CONTRAINDICATIONS Ceftaroline fosamil for injection is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class
• Anaphylaxis has been reported with ceftaroline
• Known serious hypersensitivity to ceftaroline or other members of the cephalosporin class

5. WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including ceftaroline. If a hypersensitivity reaction occurs, discontinue ceftaroline fosamil for injection. ( 5.1 ) Clostridiodes difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ceftaroline fosamil for injection. Evaluate if diarrhea occurs. ( 5.2 ) Neurological adverse reactions have been reported in patients treated with cephalosporins, including ceftaroline. …

6. ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated diarrhea [see Warnings and Precautions ( 5.2 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.3 )] Direct Coombs’ Test Seroconversion [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash. Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia. …

8.1 Pregnancy Risk Summary There are no adequate studies with ceftaroline fosamil in pregnant women that informed any drug associated risks. Th e background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies within the general population. …

10. OVERDOSAGE Ceftaroline fosamil for injection overdosage has occurred in patients with renal impairment. Reactions have included neurological sequelae, including encephalopathy [see Dosage and Administration (2.3), Warnings and Precautions ( 5.3 ) and Adverse Reactions (6.2)]. In the event of overdose, ceftaroline fosamil for injection should be discontinued and general supportive treatment given. Ceftaroline can be removed by hemodialysis. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.