ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactionshave been identified from spontaneous reporting or clinical studiesof barium sulfate administered orally. Because the reactions are reportedvoluntarily from population of uncertain size, it is not alwayspossible to reliably estimate their frequency or to establish causalrelationship to 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanismof Action. Due to its high atomic number, barium (the active ingredient in E-Z-HD)is opaque to x-rays and therefore acts as positive contrast agentfor radiographic studies.. 12.3 Pharmacokinetics. Under physiological conditions,barium sulfate passes through the GI tract in an unchanged form andis absorbed only in pharmacologically insignificant amounts.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. E-Z-HD is contraindicated in patients:Known or suspected perforation of the GI tractKnown obstruction of the GI tractAt 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 pelvisAt high risk of aspiration such as those with prior aspiration,tracheo-esophageal fistula, or obtundationWith known severe hypersensitivity to barium sulfate orany of the E-Z-HD excipients. Known or suspected perforation of the GI tract. Known obstruction of the GI tract. At 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. At 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 E-Z-HD excipients. Known or suspected perforation of the GI tract (4)Conditions associated to high risk of aspiration (4)Conditions associated to high risk of GI perforation (4)Known hypersensitivity to barium sulfate or any of the excipientsof E-Z-HD (4). Known or suspected perforation of the GI tract (4). Conditions associated to high risk of aspiration (4). Conditions associated to high risk of GI perforation (4). Known hypersensitivity to barium sulfate or any of the excipientsof E-Z-HD (4).

DESCRIPTION SECTION.

11 DESCRIPTION. E-Z-HD (barium sulfate) is aradiographic contrast agent that is supplied as fine, white to lightlycolored powder for suspension (98 w/w) for oral administration.The active ingredient barium sulfate is designated chemically as BaSO4 with molecular weight of 233.43 g/mol, densityof 4.5 g/cm3, and the following chemicalstructure:E-Z-HD contains excipients including: acacia,artificial cherry flavor, artificial strawberry flavor, carrageenan,citric acid, ethyl maltol, polysorbate 80, saccharin sodium, simethicone,sodium citrate, and sorbitol.. barium-sulfate-structure.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. Recommended reconstituted oral dose for adults and pediatricpatients 12 years and older is between 65 mL to 135 mL (155 to 321grams of barium sulfate, respectively) (2.1) Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions(2.2). Recommended reconstituted oral dose for adults and pediatricpatients 12 years and older is between 65 mL to 135 mL (155 to 321grams of barium sulfate, respectively) (2.1) Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions(2.2). 2.1 RecommendedDosage. Therecommended dose of reconstituted E-Z-HD for adults and pediatricpatients 12 years and olderis between 65 and135 mL given orally (155 to 321 grams of barium sulfate, respectively).Volumes closer to 65 mL are recommended for the examination of theesophagus and volumes up to 135 mL are recommended for examinationof the entire upper GI tract.. 2.2 Instructionsfor Reconstitution. The E-Z-HD powder must be reconstituted priorto administration by healthcare provider according to the followinginstructions:Accurately measure 65 mL of water and add this water tothe bottle containing the supplied E-Z-HD powderReplace cap securely on bottle and shake vigorously for30 secondsWait minutes and re-shake bottle thoroughly. Reconstitutionyields approximately 140 mL of E-Z-HD for oral suspension containing2.38 grams of barium sulfate per mL. Accurately measure 65 mL of water and add this water tothe bottle containing the supplied E-Z-HD powder. Replace cap securely on bottle and shake vigorously for30 seconds. Wait minutes and re-shake bottle thoroughly. Reconstitutionyields approximately 140 mL of E-Z-HD for oral suspension containing2.38 grams of barium sulfate per mL. 2.3 AdministrationInstructions. Administer the reconstituted E-Z-HD for oral suspensionimmediately upon reconstitutionTo use with straw, remove the adhesive label from topof the cap. Remove cap and use straw to push out cap liner. ReplacecapDiscard any unused suspensionAdvise patients to hydrate following the barium sulfateprocedure. Administer the reconstituted E-Z-HD for oral suspensionimmediately upon reconstitution. To use with straw, remove the adhesive label from topof the cap. Remove cap and use straw to push out cap liner. Replacecap. Discard any unused suspension. Advise patients to hydrate following the barium sulfateprocedure.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. For oral suspension: 334 gramsof barium sulfate supplied as fine, white to lightly colored powder(98 w/w) in single-dose HDPE plastic bottle for reconstitution.The suspension is 238% w/v when reconstituted and should be homogeneousand white to lightly colored.. For oral suspension: 334 gramsof barium sulfate (98 w/w) in single-dose bottle for reconstitution(3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGEAND HANDLING. 16.1 How SuppliedE-Z-HD (barium sulfate)for suspension, is supplied as fine, white to lightly colored powder(98 w/w) in single-dose HDPE plastic bottle containing 334 gramsof barium sulfate. Provided as: 24 bottles per pack (NDC 32909-764-01)16.2 Storage and HandlingStore at USP controlled room temperature, 20 to 25C (68 to 77F).

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. E-Z-HD is indicated for use in double-contrastradiographic examinations of the esophagus, stomach and duodenum tohelp visualize the gastrointestinal (GI) tract in patients 12 yearsand older.. E-Z-HD, radiographic contrastagent, is indicated for use in double-contrast radiographic examinationsof the esophagus, stomach and duodenum to visualize the gastrointestinal(GI) tract in patients 12 years and older (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. After administration advise patients to:Maintain adequate hydrationSeek medical attention for worsening of constipation orslow gastrointestinal passageSeek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficultyManufactured byEZEM Canada IncAnjou (Quebec) Canada H1J 2Z4 ForBracco Diagnostics Inc.Monroe Township, NJ 08831 Revised February 2017. Maintain adequate hydration. Seek medical attention for worsening of constipation orslow gastrointestinal passage. Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis,Mutagenesis, Impairment of Fertility. No animal studies have been performed toevaluate the carcinogenic potential of barium sulfate or potentialeffects on fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

EZ-HDLabelsNDC: 32909-764-01. e-z-hd-unit-label. e-z-hd-external-label.

RECENT MAJOR CHANGES SECTION.

RECENT MAJOR CHANGES. Warnings and Precautions (5.6)2/2017.

SPL UNCLASSIFIED SECTION.

2.1 RecommendedDosage. Therecommended dose of reconstituted E-Z-HD for adults and pediatricpatients 12 years and olderis between 65 and135 mL given orally (155 to 321 grams of barium sulfate, respectively).Volumes closer to 65 mL are recommended for the examination of theesophagus and volumes up to 135 mL are recommended for examinationof the entire upper GI tract.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryE-Z-HD is not absorbed systemically followingoral administration, and maternal use is not expected to result infetal exposure to the drug.. 8.2 Lactation. Risk SummaryE-Z-HDis not absorbed systemically by the mother following oral administration,and breastfeeding is not expected to result in exposure of the infantto E-Z-HD.. 8.4 Pediatric Use. Double-contrast radiographicexaminations of the esophagus, stomach and duodenum may be used inpediatric patients 12 years and older.E-Z-HD is contraindicatedin pediatric patients with tracheo-esophageal fistula. [seeContraindications (4)]. Pediatricpatients with history of asthma or food allergies may be at increasedrisk for 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)] 8.5 GeriatricUse. Clinicalstudies of E-Z-HD did not include sufficient numbers of subjects aged65 and over to determine whether they respond differently from youngersubjects. Other reported clinical experience has not identified differencesin responses between the elderly and younger patients. In general,dose selection for an elderly patient should be cautious, usuallystarting at the low end of the dosing range, reflecting the greaterfrequency of decreased hepatic, renal, or cardiac function, and ofconcomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Emergency equipment and trained personnel should be immediatelyavailable for treatment of serious hypersensitivity reaction (5.1)Intra-abdominal leakage: Caution is recommended in patientconditions like GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2) Patients should maintain adequate hydration in days followinga barium sulfate procedure to avoid obstruction or impaction causedby baroliths (5.3)Aspiration: Caution is recommended in patients with historyof food aspiration and in patients with known swallowing disorders(5.4)E-Z-HD is not intended for pediatric use from birth through11 years of age (8.4). Emergency equipment and trained personnel should be immediatelyavailable for treatment of serious hypersensitivity reaction (5.1). Intra-abdominal leakage: Caution is recommended in patientconditions like GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2) Patients should maintain adequate hydration in days followinga barium sulfate procedure to avoid obstruction or impaction causedby baroliths (5.3). Aspiration: Caution is recommended in patients with historyof food aspiration and in patients with known swallowing disorders(5.4). E-Z-HD is not intended for pediatric use from birth through11 years of age (8.4). 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, ora previous reaction to contrast agent may increase the risk forhypersensitivity reactions. Emergency equipment and trained personnelshould be immediately available for treatment of hypersensitivityreaction.. 5.2 Intra-abdominal BariumLeakage. Theuse of E-Z-HD is contraindicated in patients at high risk of perforationof the GI tract [see Contraindications (4)]. Administration of E-Z-HD may result in leakageof barium from the GI tract in the presence of conditions such ascarcinomas, GI fistula, inflammatory bowel disease, gastric or duodenalulcer, appendicitis, or diverticulitis, and in patients with severestenosis at any level of the GI tract, especially if it is distalto the stomach. The barium leakage has been associated with peritonitisand granuloma formation. 5.3 Delayed GastrointestinalTransit and Obstruction. Orally administered bariumsulfate may accumulate proximal to constricting lesion of the colon,causing obstruction or impaction with development of baroliths (inspissatedbarium associated with feces) and may lead to abdominal pain, appendicitis,bowel obstruction, or rarely perforation. Patients with the followingconditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility,electrolyte imbalance, dehydration, on low residue diet, takingmedications that delay GI motility, constipation, pediatric patientswith cystic fibrosis or 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 Aspiration Pneumonitis. The use of E-Z-HD is contraindicatedin patients at high risk of aspiration [see Contraindications(4)]. Oral administrationof barium is associated with aspiration pneumonitis, especially inpatients with history of food aspiration or with compromised swallowingmechanism. Vomiting following oral administration of barium sulfatemay lead to aspiration pneumonitis. In patients at risk for aspiration,begin the procedure with small ingested volume of E-Z-HD. Discontinueadministration of E-Z-HD 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 Risk with Hereditary Fructose Intolerance. E-Z-HD containssorbitol which may cause severe reactions if ingested by patientswith hereditary fructose intolerance, such as: vomiting, hypoglycemia,jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of E-Z-HD assess patients for history ofhereditary fructose intolerance and avoid use in these patients.