ENTERO Vu 24%

ENTERO VU 24% is indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients. ENTERO VU 24% is a radiographic contrast agent indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients (1)

For oral use only: Adults: Recommended dose is 600 mL (2.1)

2.1Recommended Dosing

The recommended oral dose of ENTERO VU 24% is: Adults: 600 mL

2.2Administration Instructions

For oral use only Shake bottle vigorously prior to oral administration to fully suspend product Administer undiluted Discard any unused suspension Advise patients to hydrate following the barium sulfate procedure Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.

Oral suspension: barium sulfate (24% w/v) supplied in a single-dose white HDPE plastic bottle as a ready-to-use suspension for oral administration. Each bottle contains 600 mL of suspension. Oral Suspension: barium sulfate (24% w/v) supplied in single dose bottle (3)

ENTERO VU 24% 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 known or suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of ENTERO VU 24% 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 ENTERO VU 24% (4)

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

8.1Pregnancy Risk Summary

ENTERO VU 24% is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary ENTERO VU 24% 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. 8.4 Pediatric Use ENTERO VU 24% is not indicated for pediatric use. 8.5 Geriatric Use Clinical studies of ENTERO VU 24% did 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.

Risk Summary ENTERO VU 24% is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.

ENTERO VU 24% is not indicated for pediatric use.

Clinical studies of ENTERO VU 24% did 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.

ENTERO VU 24% (barium sulfate) is a radiographic contrast agent that is supplied as a suspension (24% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm 3, and the following chemical structure ENTERO VU 24% contains the following excipients: acacia, carrageenan, citric acid, methylcellulose, natural and artificial blueberry flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, and xanthan gum. Barium Sulfate Chemical Structure

Due to its high atomic number, barium (the active ingredient in ENTERO VU 24%) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

16.1How Supplied

ENTERO VU 24% (barium sulfate) is supplied as a suspension (24% w/v) in a single-dose HDPE plastic bottle containing 600 mL of barium sulfate suspension (24% w/v). Provided as: 6 x 600 mL bottles (NDC 32909-146-06)

16.2Storage and Handling

Store at USP controlled room temperature 20°C to 25°C (68°F to 77° F). Protect from freezing.

16.1How Supplied

ENTERO VU 24% (barium sulfate) is supplied as a suspension (24% w/v) in a single-dose HDPE plastic bottle containing 600 mL of barium sulfate suspension (24% w/v). Provided as: 6 x 600 mL bottles (NDC 32909-146-06)