Tagitol V 400 mg/mL
Barium Sulfate · SUSPENSION · E-Z-EM Canada Inc
Tagitol V is a suspension containing barium sulfate at 400 mg/mL, taken oral. Manufactured by E-Z-EM Canada Inc.
Key Facts
- Brand Name
- Tagitol V
- Generic Name
- Barium Sulfate
- NDC Code (Product)
32909-814- Manufacturer
- E-Z-EM Canada Inc
- Strength
- 400 mg/mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- NDA208143
- Drug Class
- Radiographic Contrast Agent [EPC]
- Marketing Start
- 08/04/2017
Recall History
Bracco Diagnostics Inc
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & 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.
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
Frequently Asked Questions
What is Tagitol V used for?
Tagitol V contains Barium Sulfate. It is a suspension taken oral. Consult your doctor for specific uses.
Is Tagitol V a controlled substance?
Tagitol V is not classified as a controlled substance by the DEA.
What is the generic name for Tagitol V?
The generic name for Tagitol V is Barium Sulfate. There are 11 other brand versions of Barium Sulfate.
What is the NDC code for Tagitol V 400 mg/mL?
The NDC (National Drug Code) for Tagitol V 400 mg/mL is 32909-814, listed by E-Z-EM Canada Inc.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)