ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions have beenidentified from spontaneous reporting or clinical studies of bariumsulfate administered orally. Because the reactions are reported voluntarilyfrom population of uncertain size, it is not always possible toreliably estimate their frequency or to establish causal relationshipto drug exposureNausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Nausea, vomiting, diarrhea and abdominal cramping. Serious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Common adverse reactions includenausea, vomiting, diarrhea and abdominal cramping (6)To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDAat 1-800-FDA-1088 or www.fda.gov/medwatch.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. E-Z-PAQUE is contraindicated in patients withthe following conditions:Known or suspected perforation of the GI tractKnown obstruction of the GI tractHigh risk of GI perforation such as those with recentprior GI perforation, acute GI hemorrhage or ischemia, toxic megacolon,severe ileus, post GI surgery or biopsy, acute GI injury or burn,or recent radiotherapy to the pelvisHigh risk of aspiration such as those with prior aspiration,tracheo-esophageal fistula, or obtundationWith known severe hypersensitivity to barium sulfate orany of the excipients of E-Z-PAQUE. Known or suspected perforation of the GI tract. Known obstruction of the GI tract. High risk of GI perforation such as those with recentprior GI perforation, acute GI hemorrhage or ischemia, toxic megacolon,severe ileus, post GI surgery or biopsy, acute GI injury or burn,or recent radiotherapy to the pelvis. High risk of aspiration such as those with prior aspiration,tracheo-esophageal fistula, or obtundation. With known severe hypersensitivity to barium sulfate orany of the excipients of E-Z-PAQUE. Known or suspected perforation of the GI tract (4)Known obstruction of the GI tract (4)Conditions associated to high risk of GI aspiration (4)Conditions associated to high risk of GI perforation (4)Known hypersensitivity to barium sulfate or any of the excipientsof E-Z-PAQUE (4). Known or suspected perforation of the GI tract (4). Known obstruction of the GI tract (4). Conditions associated to high risk of GI aspiration (4). Conditions associated to high risk of GI perforation (4). Known hypersensitivity to barium sulfate or any of the excipientsof E-Z-PAQUE (4).

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. Adults: Recommended reconstituted oral dose is between150 750 mL (2.1)Pediatric patients: adjust reconstituted dose based on relativeGI volume (2.1)Must reconstitute supplied powder with water prior to use.See Full Prescribing Information for reconstitution instructions (2.2). Adults: Recommended reconstituted oral dose is between150 750 mL (2.1). Pediatric patients: adjust reconstituted dose based on relativeGI volume (2.1). Must reconstitute supplied powder with water prior to use.See Full Prescribing Information for reconstitution instructions (2.2). 2.1 RecommendedDosage. Theoptimal oral dose of E-Z-PAQUE will vary depending on the size andanatomy of the patient and the procedure being performed. The recommendedoral dose of reconstituted E-Z-PAQUE:Adults: 150 to 750 mL, 169 to 450 barium sulfate, dependingon the reconstituted concentration [see Dosage and Administration(2.2)].Volumes closer to 150 mL are recommended for examinationof the esophagus and stomach.Volumes up to 750 mL are recommended for examination ofthe small bowel. Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUEbased on GI volume.For examinations of the upper GI tract, administer volumesufficient to fully distend the esophagus or stomach.For small bowel examinations:Age birth to less than years: 30 mL to 75 mL.Age years to less than 17 years: 75 mL to 480 mL. Adults: 150 to 750 mL, 169 to 450 barium sulfate, dependingon the reconstituted concentration [see Dosage and Administration(2.2)].Volumes closer to 150 mL are recommended for examinationof the esophagus and stomach.Volumes up to 750 mL are recommended for examination ofthe small bowel. Volumes closer to 150 mL are recommended for examinationof the esophagus and stomach.. Volumes up to 750 mL are recommended for examination ofthe small bowel.. Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUEbased on GI volume.For examinations of the upper GI tract, administer volumesufficient to fully distend the esophagus or stomach.For small bowel examinations:Age birth to less than years: 30 mL to 75 mL.Age years to less than 17 years: 75 mL to 480 mL. For examinations of the upper GI tract, administer volumesufficient to fully distend the esophagus or stomach.. For small bowel examinations:Age birth to less than years: 30 mL to 75 mL.Age years to less than 17 years: 75 mL to 480 mL. Age birth to less than years: 30 mL to 75 mL.. Age years to less than 17 years: 75 mL to 480 mL.. 2.2 Instructions for Reconstitution. The reconstituted concentration will vary,depending on the procedure being performed.A barium suspension up to 115% w/v is recommended for examinationsof the esophagus and upper GIA barium suspension of 60% w/v is recommended for examinationsof the small bowel.Reconstitute the E-Z-PAQUEprior to administration according to the following instructions:Tap bottle on hard surface (right side up) several timesto compact the product in the bottle.Add water to the blue line marked Initial Fill Line onthe bottle.Replace cap securely on the bottle.Invert bottle and tap with fingers to mix contrast intothe water.Shake vigorously for 30 seconds; wait minutes.Add more water as needed to achieve the desired w/v concentrationusing the fill lines marked on the bottle. Then, re-shake vigorouslyfor 30 seconds.To use with straw, remove adhesive label on top of cap.Remove cap and use straw to push out cap liner; replacecap.. barium suspension up to 115% w/v is recommended for examinationsof the esophagus and upper GI. barium suspension of 60% w/v is recommended for examinationsof the small bowel.. Tap bottle on hard surface (right side up) several timesto compact the product in the bottle.. Add water to the blue line marked Initial Fill Line onthe bottle.. Replace cap securely on the bottle.. Invert bottle and tap with fingers to mix contrast intothe water.. Shake vigorously for 30 seconds; wait minutes.. Add more water as needed to achieve the desired w/v concentrationusing the fill lines marked on the bottle. Then, re-shake vigorouslyfor 30 seconds.. To use with straw, remove adhesive label on top of cap.. Remove cap and use straw to push out cap liner; replacecap.. 2.3 Administration Instructions. Use immediately after reconstitution.Ensure patients have nothing by mouth for the followingtime period prior to the examination: Neonates and infants 3 months hoursInfants 3-12 months hours> 12 months of age hours Discard any unused suspension.Encourage patients to maintain hydration following the bariumsulfate procedure.. Use immediately after reconstitution.. Ensure patients have nothing by mouth for the followingtime period prior to the examination: Neonates and infants 3 months hoursInfants 3-12 months hours> 12 months of age hours Neonates and infants 3 months hours. Infants 3-12 months hours. 12 months of age hours. Discard any unused suspension.. Encourage patients to maintain hydration following the bariumsulfate procedure.

SPL UNCLASSIFIED SECTION.

2.1 RecommendedDosage. Theoptimal oral dose of E-Z-PAQUE will vary depending on the size andanatomy of the patient and the procedure being performed. The recommendedoral dose of reconstituted E-Z-PAQUE:Adults: 150 to 750 mL, 169 to 450 barium sulfate, dependingon the reconstituted concentration [see Dosage and Administration(2.2)].Volumes closer to 150 mL are recommended for examinationof the esophagus and stomach.Volumes up to 750 mL are recommended for examination ofthe small bowel. Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUEbased on GI volume.For examinations of the upper GI tract, administer volumesufficient to fully distend the esophagus or stomach.For small bowel examinations:Age birth to less than years: 30 mL to 75 mL.Age years to less than 17 years: 75 mL to 480 mL. Adults: 150 to 750 mL, 169 to 450 barium sulfate, dependingon the reconstituted concentration [see Dosage and Administration(2.2)].Volumes closer to 150 mL are recommended for examinationof the esophagus and stomach.Volumes up to 750 mL are recommended for examination ofthe small bowel. Volumes closer to 150 mL are recommended for examinationof the esophagus and stomach.. Volumes up to 750 mL are recommended for examination ofthe small bowel.. Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUEbased on GI volume.For examinations of the upper GI tract, administer volumesufficient to fully distend the esophagus or stomach.For small bowel examinations:Age birth to less than years: 30 mL to 75 mL.Age years to less than 17 years: 75 mL to 480 mL. For examinations of the upper GI tract, administer volumesufficient to fully distend the esophagus or stomach.. For small bowel examinations:Age birth to less than years: 30 mL to 75 mL.Age years to less than 17 years: 75 mL to 480 mL. Age birth to less than years: 30 mL to 75 mL.. Age years to less than 17 years: 75 mL to 480 mL.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryE-Z-PAQUE is not absorbed systemically followingoral administration, and maternal use is not expected to result infetal exposure to the drug [see Clinical Pharmacology (12.3)].. 8.2 Lactation. Risk SummaryE-Z-PAQUE is not absorbed systemically bythe mother following oral administration, and breastfeeding is notexpected to result in exposure of the infant to E-Z-PAQUE [see Clinical Pharmacology (12.3)].. 8.4 PediatricUse. The efficacyof E-Z-PAQUE in pediatric patients from birth to less than 17 yearsof age is based on successful opacification of the esophagus, stomach,duodenum and small bowel during radiologic examinations [seeClinical Pharmacology (12.1)]. Safety and dosing recommendations in pediatric patients are basedon clinical experience [see Dosage and Administration (2.1)].E-Z-PAQUE is contraindicated in pediatricpatients with tracheo-esophageal fistula [see Contraindications(4)]. Pediatric patientswith history of asthma or food allergies may be at increased riskfor development of hypersensitivity reactions [see Warningsand Precautions (5.1)]. Pediatric patients with cystic fibrosis or Hirschsprung disease shouldbe monitored for bowel obstruction after use [see Warningsand Precautions (5.3)]. Pediatric patients with hereditary fructose intolerance may developsevere symptoms with administration of E-Z-Paque; assess for thisrisk and avoid use in patients with hereditary fructose intolerance [see Warnings and Precautions (5.6)].. 8.5 GeriatricUse. Clinicalstudies of E-Z-PAQUE did not include sufficient numbers of subjectsaged 65 and over to determine whether they respond differently fromyounger subjects. Other reported clinical experience has not identifieddifferences in responses between the elderly and younger patients.In general, dose selection for an elderly patient should be cautious,usually starting at the low end of the dosing range, reflecting thegreater frequency of decreased hepatic, renal, or cardiac function,and of concomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2)Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction caused by baroliths (5.3)Aspiration pneumonitis: Patients with history of food aspirationor with swallowing disorders are at increased risk. (5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2). Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction caused by baroliths (5.3). Aspiration pneumonitis: Patients with history of food aspirationor with swallowing disorders are at increased risk. (5.4). 5.1 HypersensitivityReactions. Barium sulfate preparations contain number of excipients, includingnatural and artificial flavors and may induce serious hypersensitivityreactions. The manifestations include hypotension, bronchospasm andother respiratory impairments, dermal reactions including rashes,urticaria, and itching. history of bronchial asthma, atopy, or aprevious reaction to contrast agent may increase the risk for hypersensitivityreactions. Emergency equipment and trained personnel should be immediatelyavailable for treatment of hypersensitivity reaction.. 5.2 Intra-abdominalBarium Leakage. The use of E-Z-PAQUE is contraindicated in patients at high riskof perforation of the GI tract [see Contraindications (4)]. Administration of E-Z-PAQUEmay result in leakage of barium from the GI tract in the presenceof conditions such as carcinomas, GI fistula, inflammatory bowel disease,gastric or duodenal ulcer, appendicitis, diverticulitis, and in patientswith severe stenosis at any level of the GI tract, especially distalto the stomach. Barium leakage has been associated with peritonitisand granuloma formation.. 5.3 DelayedGastrointestinal Transit and Obstruction. Orally administered barium sulfate may accumulateproximal to constricting lesion of the colon, causing obstructionor impaction with development of baroliths (inspissated barium associatedwith feces) and may cause abdominal pain, appendicitis, bowel obstruction,or rarely perforation. Patients with the following conditions areat higher risk for developing obstruction or baroliths: severe stenosisat any level of the GI tract, impaired GI motility, electrolyte imbalance,dehydration, on low residue diet, on medications that delay GI motility,constipation, cystic fibrosis, Hirschsprung disease, and the elderly [see Use in Specific Populations (8.4, 8.5)]. To reduce therisk of delayed GI transit and obstruction, patients should maintainadequate hydration during and in the days following barium sulfateprocedure. Consider the administration of laxatives.. 5.4 AspirationPneumonitis. The use of E-Z-PAQUE is contraindicated in patients at high riskof aspiration [see Contraindications (4)]. Oral administration of barium is associatedwith aspiration pneumonitis, especially in patients with historyof food aspiration or with compromised swallowing mechanism. Vomitingfollowing oral administration of barium sulfate may lead to aspirationpneumonitis. In patients at risk for aspiration, begin the procedurewith small ingested volume of E-Z-PAQUE. Discontinue administrationof E-Z-PAQUE immediately if aspiration is suspected.. 5.5 SystemicEmbolization. Barium sulfate products may occasionally intravasate into the venousdrainage of the large bowel and enter the circulation as bariumembolus leading to potentially fatal complications which includesystemic and pulmonary embolism, disseminated intravascular coagulation,septicemia and prolonged severe hypotension. Although this complicationis exceedingly uncommon after oral administration of barium sulfatesuspension, monitor patients for potential intravasation when administeringbarium sulfate.. 5.6 Riskwith Hereditary Fructose Intolerance. E-Z-PAQUE contains sorbitol which may causesevere symptoms if ingested by patients with hereditary fructose intolerance. Severe symptoms may include the following: vomiting, hypoglycemia,jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of E-Z-PAQUE assess patients for historyof hereditary fructose intolerance and avoid use in these patients.