Indications
VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older ( 1 )
Contraindications
VARIBAR PUDDING is contraindicated in patients with: - known or suspected perforation of the gastrointestinal (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 for aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; - known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING.
VARIBAR PUDDING is contraindicated in patients with: Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Conditions associated with high risk for GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Patients with trachea-esophageal fistula ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING ( 4 )
Warnings and precautions
Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal leakage: May occur with conditions which increase the risk for perforation such as – carcinomas, GI fistula, Inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, diverticulitis, or severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction by baroliths ( 5.3 ) Aspiration Pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration ( 5.4 )