Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
03/14/2019
Trade Name:
Avycaz
Generic Name or Proper Name (*):
ceftazidime/ avibactam
Indications Studied:
Treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) to include patients 3 months to less than 18 years
Label Changes Summary:
*Safety and effectiveness in the treatment of cUTI and cIAI have been established in pediatric patients 3 months to less than 18 years. Use in these age groups is supported by evidence from adequate and well-controlled studies of Avycaz in adults with cUTI and cIAI and additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 3 months with cUTI or cIAI have not been established. *Safety and effectiveness in pediatric patients less than 18 years of age with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia have not been established. *Dosage adjustment is required in pediatric patients with cIAI or cUTI and renal impairment from 2 years to < 18 years with eGFR 50 mL/min/1.73 m2 or less. There is insufficient information to recommend a dosing regimen for pediatric patients younger than 2 years of age with cIAI or cUTI and renal impairment. * Safety in patients ages 3 months to less than 18 years was similar to that observed in adults. *Information on recommended dosing, dosing in renal impairment patients, PK parameters and clinical trials in patients ages 3 months to less than 18 years. *Postmarketing study.
Product Labeling:
[INVALID]
PREA(P):
P
Sponsor:
Allergan
NNPS:
FALSE
Therapeutic Category:
Antibiotic
-
-