Data from FDA - Curated by Marshall Pearce - Last updated 05 December 2017

Indication(s)

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)

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Advisory information

contraindications
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)
Adverse reactions
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

Usage information

Dosing and administration
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.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary TAGITOLVis 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)]. 8.2 Lactation Risk Summary TAGITOL V is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the infant to the drug [see Clinical Pharmacology (12.3)] 8.4 Pediatric Use TAGITOL V is not indicated for pediatric use. 8.5 Geriatric Use Clinical studies of TAGITOL V do not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

More information

Category Value
Authorisation number NDA208143
Agency product number 25BB7EKE2E
Orphan designation No
Product NDC 32909-814
Date Last Revised 26-08-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder E-Z-EM Canada Inc