2.1  Recommended Dosing

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

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.

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.

8.1  Pregnancy

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.

12.1  Mechanism of Action

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.

12.2  Pharmacodynamics

Barium sulfate is biologically inert and has no known pharmacological effects.

12.3  Pharmacokinetics

Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

13.1  Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

16.1  How 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)

16.2  Storage and Handling

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