5.1  Hypersensitivity Reactions

E-Z-DISK may induce serious hypersensitivity reactions with manifestations including hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, food allergies, or a reaction to a contrast agent may increase the risk for hypersensitivity reactions. E-Z-DISK is contraindicated in patients with known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Contraindications (4)]. Have emergency equipment and trained personnel immediately available during the procedure.

5.2  Intra-abdominal Barium Leakage

Barium leakage from the GI tract has been associated with peritonitis and granuloma formation. Barium sulfate from orally administered E-Z-DISK may leak in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with severe stenosis of the GI tract, especially if it is distal to the stomach. E-Z-DISK is contraindicated in patients with known, suspected, or high risk of perforation of the GI tract [see Contraindications (4)].

5.3  Baroliths and Bowel Obstruction

Barium sulfate from orally administered E-Z-DISK may accumulate in the GI tract, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, or perforation. Patients with the following are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, low residue diet, medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and advanced age. E-Z-DISK is contraindicated in patients with known obstruction of the GI tract [see Contraindications (4)]. To reduce the risk of delayed GI transit and obstruction, maintain adequate hydration after the E-Z-DISK procedure. Monitor patients at risk for delayed gastrointestinal transit for development of signs and symptoms of bowel obstruction.

5.4  Aspiration Pneumonitis

Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. E-Z-DISK is contraindicated in patients with high risk of aspiration such as known or suspected tracheoesophageal fistula or obtundation [see Contraindications (4)].

5.5  Systemic Embolization

Barium sulfate from orally administered E-Z-DISK may intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications, which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia, and prolonged severe hypotension.

8.1  Pregnancy

Risk Summary

Barium sulfate is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to E-Z-DISK [see Clinical Pharmacology (12.3)]

8.2  Lactation

Risk Summary

Barium sulfate 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-DISK.

8.4  Pediatric Use

The safety and effectiveness of E-Z-DISK for use in radiographic evaluation of esophageal patency have been established in pediatric patients 12 years and older. Use of E-Z-DISK in this age group for this indication is supported by effectiveness established in studies of adults and pediatric safety data from other barium sulfate products [see Adverse Reactions (6)].

8.5  Geriatric use

Reported clinical experience has not identified differences between elderly and younger patients.

12.1  Mechanism of Action

E-Z-DISK is formulated to pass through the esophagus into the stomach when the esophageal lumen is greater than 11.5 mm to 13.5 mm (0.45 inch to 0.53 inch) in diameter. Due to its high atomic number, barium is opaque to X-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2  Pharmacodynamics

Barium sulfate has no pharmacological effects.

12.3  Pharmacokinetics

Orally administered barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in insignificant amounts.

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.