Label: ENTERO VU 24%- barium sulfate suspension
- NDC Code(s): 32909-145-06, 32909-146-06
- Packager: E-Z-EM Canada Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated January 17, 2022
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ENTERO VU 24% safely and effectively. See full prescribing information for ENTERO VU 24%.
ENTERO VU 24% (barium sulfate) oral suspension
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
- For oral use only:
- Adults: Recommended dose is 600 mL (2.1)
DOSAGE FORMS AND STRENGTHS
- Oral Suspension: barium sulfate (24% w/v) supplied in single dose bottle (3)
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available (5.1)
- Intra-abdominal barium leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis, diverticulitis, severe stenosis or obstructing lesions of the GI tract (5.2)
- Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction (5.3)
- Aspiration Pneumonitis: Patients with a history of food aspiration or with swallowing disorders are at increased risk. Monitor patients for aspiration (5.4)
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
See 17 for PATIENT COUNSELING INFORMATION.
- For oral use only:
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.2 Administration 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.
- 3 DOSAGE FORMS AND STRENGTHS
- 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%
5 WARNINGS AND PRECAUTIONS
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, and dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, food allergies, 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 ENTERO VU 24% is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of ENTERO VU 24% may result in leakage of barium from the GI tract in the presence of conditions that increase the risk of perforation such as known carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. 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 cause abdominal pain, appendicitis, bowel obstruction, or 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 GI motility, electrolyte imbalance, dehydration, on a low residue diet, on medications that delay GI motility, constipation, and the elderly [see Use in Specific Populations (8.5)]. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure.
5.4 Aspiration Pneumonitis
The use of ENTERO VU 24% is contraindicated in patients with trachea-esophageal fistula [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. In patients at risk for aspiration, begin the procedure with a small ingested volume of ENTERO VU 24%. Monitor the patient closely for aspiration, discontinue administration of ENTERO VU 24% if aspiration is suspected, and monitor for development of 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 uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.
5.6 Risk with Hereditary Fructose Intolerance
ENTERO VU 24% contains sorbitol which may cause severe symptoms if ingested by patients with hereditary fructose intolerance. Severe symptoms may include the following: vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of ENTERO VU 24% assess patients for a history of hereditary fructose intolerance and avoid use in these patients.
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
8 USE IN SPECIFIC POPULATIONS
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.
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 BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
- 13 NONCLINICAL TOXICOLOGY
16 HOW SUPPLIED/STORAGE
17 PATIENT COUNSELING INFORMATION
- Maintain adequate hydration [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].
- Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions (5.3)].
- Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ENTERO VU 24%
barium sulfate suspension
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-145 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (UNII: 25BB7EKE2E) (BARIUM SULFATE - UNII:25BB7EKE2E) BARIUM SULFATE 240 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARRAGEENAN SODIUM (UNII: 7CY8BVL34N) DIMETHICONE 350 (UNII: 2Y53S6ATLU) DIMETHICONE 1000 (UNII: MCU2324216) METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM CHLORIDE (UNII: 660YQ98I10) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32909-145-06 12 in 1 CASE 05/01/2020 10/31/2021 1 600 mL in 1 JUG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208143 05/01/2020 10/31/2021 ENTERO VU 24%
barium sulfate suspension
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-146 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (UNII: 25BB7EKE2E) (BARIUM SULFATE - UNII:25BB7EKE2E) BARIUM SULFATE 240 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARRAGEENAN SODIUM (UNII: 7CY8BVL34N) DIMETHICONE 350 (UNII: 2Y53S6ATLU) DIMETHICONE 1000 (UNII: MCU2324216) METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM CHLORIDE (UNII: 660YQ98I10) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32909-146-06 6 in 1 CASE 10/01/2020 1 600 mL in 1 JUG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208143 10/01/2020 Labeler - E-Z-EM Canada Inc (204211163) Registrant - E-Z-EM, INC. (002041226) Establishment Name Address ID/FEI Business Operations E-Z-EM Canada Inc 204211163 LABEL(32909-145, 32909-146) , ANALYSIS(32909-145, 32909-146) , PACK(32909-146, 32909-145) , MANUFACTURE(32909-145, 32909-146)