Barium sulfate

1 INDICATIONS AND USAGE Liquid E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients. Liquid E-Z-PAQUE is a radiographic contrast agent indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients ( 1 )

2 DOSAGE AND ADMINISTRATION Adults: Recommended oral dose is 150 mL to 750 mL (87g to 435g of barium sulfate, respectively) ( 2.1 ) Pediatric patients: adjust dose based on relative GI volume ( 2.1 ) 2.1 Recommended Dosage The optimal oral dose of Liquid E-Z-PAQUE will vary depending on the size and anatomy of the patient and the procedure being performed. The recommended oral dose of Liquid E-Z-PAQUE: Adults: 150 to 750 mL (87 g to 435 g of barium sulfate, respectively). Volumes closer to 150 mL are recommended for examination of the esophagus and stomach and volumes up to 750 mL are recommended for examination of the small bowel Pediatric Patients: Adjust dose based on GI volume For examinations of the upper GI tract, administer a volume sufficient to fully distend the esophagus or stomach. For small bowel examinations: Age birth to less than 2 years: 30 mL to 75 mL Age 2 years to less than 17 years: 75 mL to 480 mL 2.2 Administration Instructions For oral use only Shake bottle vigorously for 30 seconds prior to oral administration to fully suspend product Administer undiluted Ensure patients have nothing by mouth for the following time period prior to the examination: Neonates and Infants < 3 months 2 hours Infants 3-12 months 3 hours > 12 months of age 4 hours Discard any unused suspension Encourage patients to maintain hydration following the barium sulfate procedure

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch