Teflaro

TEFLARO- ceftaroline fosamil powder, for solution
Allergan, Inc.

1. INDICATIONS AND USAGE

1.1 Acute Bacterial Skin and Skin Structure Infections

Teflaro is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Escherichia coli , Klebsiella pneumoniae , and Klebsiella oxytoca [see Dosage and Administration ( 2.2) and Use in Specific Populations ( 8.4)].

1.2 Community-Acquired Bacterial Pneumonia

Teflaro is indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

1.3 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adult Patients

The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥ 18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.

The recommended dosage and administration by infection is described in Table 1.

Table 1: Dosage of Teflaro by Indication in Adults
In dication Dosage Frequency Infusion Time Recommended Duration of Treatment
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 600 mg Every 12 hours 5 to 60 minutes 5-14 days
Community-Acquired Bacterial Pneumonia (CABP) 600 mg Every 12 hours 5 to 60 minutes 5-7 days

2.2 Recomme n ded Dosage in Pediatric Patients

The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. The duration of therapy should be guided by the severity, site of infection and the patient’s clinical and bacteriological progress.

Pediatric Patients 2 Months of Age and Older

  • For pediatric patients 2 months of age and older, Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes.
  • Teflaro dosing regimen is dependent on the type of infection (ABSSSI, CABP). See dosing Table 2 below.
Table 2: Dosage of Teflaro by Indication in Pediatric Patients 2 Months of Age and Older
Indication Age Range Dosage and Frequency Infusion time Recommended Duration of Treatment
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)ORCommunity-Acquired Bacterial Pneumonia (CABP) 2 months to < 2 years 8 mg/kg every 8 hours 5 to 60 minutes 5-14 days
> 2 years to < 18 years (< 33 kg) 12 mg/kg every 8 hours
> 2 years to < 18 years (> 33 kg) 400 mg every 8 hoursOR600 mg every 12 hours

Pediatric Patients Less Than 2 Months of Age

  • Teflaro is administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age.
  • Teflaro dosing regimen is only recommended for patients with ABSSSI. See dosing Table 3 below.
  • Concentrations of Teflaro in the cerebrospinal fluid have not been evaluated [see Use in Specific Populations ( 8.4)].
  • There is no information for dosing Teflaro in infants less than 34 weeks gestational age and less than 12 days postnatal age.
Table 3: Dosage of Teflaro in Pediatric Patients less Than 2 Months of Age
Indication Age Range Dosage and Frequency Infusion time Recommended Duration of Treatment
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 0* to < 2 months 6 mg/kg every 8 hours 30 to 60 minutes 5-14 days

*Gestational age 34 weeks and older and postnatal age 12 days and older.

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