e-z-disk

Important safety information

Hypersensitivity Reactions: Have emergency equipment and trained personnel immediately available during the procedure. ( 5.1 ) Intra-abdominal Barium Leakage: Barium leakage may occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis, diverticulitis, and severe stenosis or obstructing lesions of the GI tract and has been associated with peritonitis and granuloma formation. ( 5.2 ) Baroliths and Bowel Obstruction: Maintain adequate hydration following a barium sulfate procedure and monitor patients at risk for delayed GI transit for development of signs and symptoms of bowel obstruction. ( 5.3 ) Aspiration Pneumonitis: Patients with a history of food aspiration or compromised swallowing mechanism may be at high risk. ( 5.4 ) 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.