E-Z-Disk

E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.

The recommended dose of E-Z-DISK in adults and pediatric patients aged 12 years and older is one 700 mg tablet orally during imaging.

Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet.

Advise patients to hydrate following the E-Z-DISK imaging procedure [see Warnings and Precautions (5.3)].

E-Z-DISK is formulated to disintegrate within the gastrointestinal (GI) tract. In the event of prolonged retention, consider implementing appropriate interventions.

Tablets: 700 mg of barium sulfate as a white to lightly colored, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter, flat-sided disk with EZEM inscribed on one side and 778 on the other side.

E-Z-DISK is contraindicated in patients with:

• Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Warnings and Precautions (5.1)]
• Known, suspected, or high risk of perforation of the GI tract such as patients with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, recent GI surgery or biopsy, acute GI injury, or recent radiotherapy to the pelvis [see Warnings and Precautions (5.2)]
• Known obstruction of the GI tract [see Warnings and Precautions (5.3)]
• High risk of aspiration such as patients with known or suspected tracheoesophageal fistula or obtundation [see Warnings and Precautions (5.4)]

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
• Intra-abdominal Barium Leakage [see Warnings and Precautions (5.2)]
• Baroliths and Bowel Obstruction [see Warnings and Precautions (5.3)]
• Aspiration Pneumonitis [see Warnings and Precautions (5.4)]

The following adverse reactions associated with the use of E-Z-DISK or other barium sulfate products were identified in postmarketing reports or published clinical studies. Because some of these 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:

Cardiovascular disorders: Vasovagal and syncopal episodes
Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping
Respiratory disorders: Aspiration pneumonitis

Adverse Reactions in Pediatric Patients

No additional safety signals have been reported in pediatric patients aged 12 years and older.

E-Z-DISK (barium sulfate) tablet is a radiographic contrast agent for oral use.

Barium sulfate is designated chemically as BaSO₄ with molecular weight of 233.4 g/mol, density of 4.5 g/cm³, and the following chemical structure:

E-Z-DISK is a white to lightly colored, flat-sided disk, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter. Each tablet contains 700 mg barium sulfate and the following inactive ingredients: confectioner’s sugar, microcrystalline cellulose, corn starch, povidone, croscarmellose sodium, and magnesium stearate.

How Supplied

E-Z-DISK (barium sulfate) tablets, 700 mg, are white to lightly colored, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter, flat-sided disks with EZEM inscribed on one side and 778 on the other side supplied in a glass bottle containing 100 tablets (NDC 10361-778-31).

Storage and Handling

Store at 20°C to 25°C (68°F to 77° F) [see USP controlled room temperature]. Store in original container and protect from moisture.

Administration Instructions

Instruct patients to swallow E-Z-DISK as a whole tablet with the aid of one or two swallows of water (do not cut, crush, or chew) [see Dosage and Administration (2.2)].

Hypersensitivity Reactions

Advise patients to seek medical attention for any delayed onset of hypersensitivity such as rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].

Baroliths and Bowel Obstruction

Advise patients to drink a sufficient amount of water to maintain adequate hydration following the E-Z-DISK procedure and to seek medical attention for signs and symptoms of bowel obstruction [see Warnings and Precautions (5.3)].

Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08540

by
Confab Laboratories Inc.
Saint Hubert (Quebec) Canada J3Y 3X3

rev. 08/25      301871-02

E-Z-Disk Tablets NDC: 10361-778-3