E-Z-HD

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

4 CONTRAINDICATIONS E-Z-HD is contraindicated in patients: Known or suspected perforation of the GI tract Known obstruction of the GI tract At high risk of GI perforation such as those with a recent prior 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 or any 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 excipients of E-Z-HD ( 4 )

11 DESCRIPTION E-Z-HD (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (98 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.43 g/mol, a density of 4.5 g/cm 3 , and the following chemical structure: 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

2 DOSAGE AND ADMINISTRATION Recommended reconstituted oral dose for adults and pediatric patients 12 years and older is between 65 mL to 135 mL (155 to 321 grams 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 Recommended Dosage The recommended dose of reconstituted E-Z-HD for adults and pediatric patients 12 years and olderis between 65 and 135 mL given orally (155 to 321 grams of barium sulfate, respectively). Volumes closer to 65 mL are recommended for the examination of the esophagus and volumes up to 135 mL are recommended for examination of the entire upper GI tract. 2.2 Instructions for Reconstitution The E-Z-HD powder must be reconstituted prior to administration by a healthcare provider according to the following instructions: Accurately measure 65 mL of water and add this water to the bottle containing the supplied E-Z-HD powder Replace cap securely on bottle and shake vigorously for 30 seconds Wait 5 minutes and re-shake bottle thoroughly. Reconstitution yields approximately 140 mL of E-Z-HD for oral suspension containing 2.38 grams of barium sulfate per mL 2.3 Administration Instructions Administer the reconstituted E-Z-HD for oral suspension immediately upon reconstitution To use with a straw, remove the adhesive label from top of the cap. Remove cap and use straw to push out cap liner. Replace cap Discard any unused suspension Advise patients to hydrate following the barium sulfate procedure

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

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

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

E-Z-HD barium sulfate Barium Sulfate Barium Sulfate acacia anhydrous citric acid dimethicone 1000 ethyl maltol polysorbate 80 saccharin sodium silicon dioxide trisodium citrate dihydrate sorbitol carrageenan sodium

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

NDA208036

E-Z-HD

barium sulfate

32909-764

HUMAN PRESCRIPTION DRUG

ORAL

EZ-HD Labels NDC: 32909-764-01 e-z-hd-unit-label e-z-hd-external-label

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

17 PATIENT COUNSELING INFORMATION After administration advise patients to: Maintain adequate hydration Seek medical attention for worsening of constipation or slow gastrointestinal passage Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty Manufactured by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 For Bracco Diagnostics Inc. Monroe Township, NJ 08831 CL80608 Revised December 2021

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary E-Z-HD is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary E-Z-HD is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to E-Z-HD. 8.4 Pediatric Use Double-contrast radiographic examinations of the esophagus, stomach and duodenum may be used in pediatric patients 12 years and older. E-Z-HD is contraindicated in pediatric patients with tracheo-esophageal fistula. [see Contraindications ( 4 )]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [ see Warnings and Precautions ( 5.1 )]. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions ( 5.3 )] 8.5 Geriatric Use Clinical studies of E-Z-HD did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences 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 the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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