Tagitol V

Liquid E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients. Liquid E-Z-PAQUE is a radiographic contrast agent indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients ( 1 )

Liquid E-Z-PAQUE is contraindicated in patients with the following conditions: known or suspected perforation of the GI tract known obstruction of the GI tract high risk of GI perforation such as those with a recent 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 high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE ( 4 )

Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal barium leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction ( 5.3 ) Aspiration pneumonitis: Patients with history of food aspiration or with swallowing disorders are at increased risk ( 5.4 )

5.1Hypersensitivity 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.