Entero Vu 24%- Barium Sulfate suspension

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

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

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

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.

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

• Hypersensitivity reactions: Emergency equipment and trained
  personnel should be immediately available (
  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.
  )
• 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  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 ]

  . 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.
  )
• Delayed GI transit and obstruction: Patients should maintain
  adequate hydration in days following barium sulfate procedure to avoid
  obstruction or impaction (
  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
  ]

  . To reduce the risk
  of delayed GI transit and obstruction, patients should maintain adequate
  hydration after the barium sulfate procedure.
  )
• Aspiration Pneumonitis: Patients with a history of food
  aspiration or with swallowing disorders are at increased risk. Monitor
  patients for aspiration (
  5.4  Aspiration Pneumonitis

  The use of ENTERO VU 24% is
  contraindicated in patients with trachea-esophageal fistula

  [see Contraindications ]

  . 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.
  )