Drug Interactions The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.
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 )] Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK ( 4 ) Known or suspected perforation of the gastrointestinal (GI) tract or conditions associated with high risk of GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of aspiration ( 4 )
AND PRECAUTIONS Emergency equipment and trained personnel should be immediately available for treatment of a serious hypersensitivity reaction ( 5.1 ) Intra-abdominal leakage: Caution is recommended in patient conditions like GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction caused by baroliths ( 5.3 ) Aspiration: Caution is recommended in patients with history of food aspiration and in patients with known swallowing disorders ( 5.4 ) E-Z-HD is not intended for pediatric use from birth through 11 years of age ( 8.4 )
5.1 Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.
5.2 Intra-abdominal Barium Leakage The use of E-Z-HD is contraindicated in patients at high risk of perforation of the GI tract <span class="opacity-50 text-xs">[see Contraindications ( 4 )]</span>. Administration of E-Z-HD may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.
5.3 Delayed Gastrointestinal Transit and Obstruction Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions 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 a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.4 , 8.5 )]</span> . To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration during and in the days following a barium sulfate procedure. Consider the administration of laxatives.
5.4 Aspiration Pneumonitis The use of E-Z-HD is contraindicated in patients at high risk of aspiration <span class="opacity-50 text-xs">[see Contraindications ( 4 )]</span> . 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. In patients at risk for aspiration, begin the procedure with a small ingested volume of E-Z-HD. Discontinue administration of E-Z-HD immediately if aspiration is suspected.
5.5 Systemic Embolization Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel 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. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.
5.6 Risk with Hereditary Fructose Intolerance E-Z-HD contains sorbitol which may cause severe reactions if ingested by patients with hereditary fructose intolerance, such as: vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of E-Z-HD assess patients for a history of hereditary fructose intolerance and avoid use in these patients.