Tagitol V

1 INDICATIONS AND USAGE TAGITOL V is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent. TAGITOL V is a radiographic contrast agent indicated in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent ( 1 )

2 DOSAGE AND ADMINISTRATION The recommended dose is: One 20 mL bottle (8g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the CT colonography examination ( 2.1 ). Total dose = 3 bottles (24 g barium sulfate) For oral use only ( 2.2 ). 2.1 Recommended Dosing The recommended oral dose of TAGITOL V is one 20 mL bottle (8 g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose = 3 bottles (24 g barium sulfate). 2.2 Important Administration Instructions TAGITOL V is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient. Shake bottle for 15 seconds prior to administration. For oral use only. Encourage patients to hydrate following the barium sulfate procedure. Discard any unused suspension.

4 CONTRAINDICATIONS TAGITOL V 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 of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation; - known hypersensitivity to barium sulfate or any of the excipients of TAGITOL V. TAGITOL V is contraindicated in patients with: Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of TAGITOL V ( 4 )

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal barium leakage: May occur in conditions which increase the risk of perforation such as - carcinoma, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, diverticulitis, or 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 by baroliths ( 5.3 ) Aspiration pneumonitis: Caution is recommended in patients with a history of food aspiration and in patients with known swallowing disorders ( 5.4 ) 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 TAGITOL V is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications ( 4 )]. Administration of TAGITOL V may result in leakage of barium from the GI tract in the presence of conditions that increase the risk of perforation 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 gastrointestinal 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 gastrointestinal motility, electrolyte imbalance, dehydration, on a low residue diet, on medications that delay GI motility, constipation, cystic fibrosis, Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure. 5.4 Aspiration Pneumonitis The use of TAGITOL V is contraindicated in patients at high risk of aspiration [see Contraindications ( 4 )]. 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. 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 barium sulfate products, monitor patients for potential intravasation when administering barium sulfate.

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes. Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

8.1 Pregnancy Risk Summary TAGITOLV is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] .