E-z-paque

E-Z-PAQUE is indicated for use
in single contrast radiographic examinations of the esophagus, stomach,
duodenum and small bowel to visualize the gastrointestinal tract (GI)
in adult and pediatric patients.

• Adults: Recommended reconstituted oral dose is between
  150 – 750 mL (
  2.1 Recommended
  Dosage

  The
  optimal oral dose of E-Z-PAQUE will vary depending on the size and
  anatomy of the patient and the procedure being performed. The recommended
  oral dose of reconstituted E-Z-PAQUE:

  • Adults: 150 to 750 mL, 169 to 450 g barium sulfate, depending
    on the reconstituted concentration
    [see Dosage and Administration
    ]
    .
    • Volumes closer to 150 mL are recommended for examination
      of the esophagus and stomach.
    • Volumes up to 750 mL are recommended for examination of
      the small bowel.
  • Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUE
    based on GI volume.
    • For examinations of the upper GI tract, administer a volume
      sufficient to fully distend the esophagus or stomach.
    • For small bowel examinations:
      • Age birth to less than 2 years: 30 mL to 75 mL.
      • Age 2 years to less than 17 years: 75 mL to 480 mL.
  )
• Pediatric patients: adjust reconstituted dose based on relative
  GI volume (
  2.1 Recommended
  Dosage

  The
  optimal oral dose of E-Z-PAQUE will vary depending on the size and
  anatomy of the patient and the procedure being performed. The recommended
  oral dose of reconstituted E-Z-PAQUE:

  • Adults: 150 to 750 mL, 169 to 450 g barium sulfate, depending
    on the reconstituted concentration
    [see Dosage and Administration
    ]
    .
    • Volumes closer to 150 mL are recommended for examination
      of the esophagus and stomach.
    • Volumes up to 750 mL are recommended for examination of
      the small bowel.
  • Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUE
    based on GI volume.
    • For examinations of the upper GI tract, administer a volume
      sufficient to fully distend the esophagus or stomach.
    • For small bowel examinations:
      • Age birth to less than 2 years: 30 mL to 75 mL.
      • Age 2 years to less than 17 years: 75 mL to 480 mL.
  )
• Must reconstitute supplied powder with water prior to use.
  See Full Prescribing Information for reconstitution instructions (
  2.2 Instructions for Reconstitution

  The reconstituted concentration will vary,
  depending on the procedure being performed.

  • A barium suspension up to 115% w/v is recommended for examinations
    of the esophagus and upper GI
  • A barium suspension of 60% w/v is recommended for examinations
    of the small bowel.

  Reconstitute the E-Z-PAQUE
  prior to administration according to the following instructions:

  • Tap bottle on a hard surface (right side up) several times
    to compact the product in the bottle.
  • Add water to the blue line marked ‘Initial Fill Line’ on
    the bottle.
  • Replace cap securely on the bottle.
  • Invert bottle and tap with fingers to mix contrast into
    the water.
  • Shake vigorously for 30 seconds; wait 5 minutes.
  • Add more water as needed to achieve the desired % w/v concentration
    using the fill lines marked on the bottle. Then, re-shake vigorously
    for 30 seconds.
  • To use with straw, remove adhesive label on top of cap.
  • Remove cap and use straw to push out cap liner; replace
    cap.
  )

For oral suspension: 169 g of
barium sulfate supplied as a fine, white to lightly colored powder
(96 % w/w) in a single-dose HDPE plastic bottle for reconstitution.
The suspension can be reconstituted to a desired strength of 60,
70, 85, 100, or 115% w/v when prepared according to the corresponding
fill line on the bottle. The reconstituted solution should be opaque,
white to lightly-colored and free from particles.

Risk Summary

E-Z-PAQUE 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, dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, 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
  or diverticulitis, severe stenosis or obstructing lesions of the GI
  tract (
  5.2 Intra-abdominal
  Barium Leakage

  The use of E-Z-PAQUE is contraindicated in patients at high risk of perforation of the GI tract

  [see Contraindications ].

  Administration of E-Z-PAQUE may result in leakage of barium from the GI tract in the presence of conditions such as 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 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 a barium sulfate procedure to
  avoid obstruction or impaction caused by baroliths (
  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 rarely 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, cystic fibrosis, Hirschsprung disease, and the elderly

  [see Use in Specific Populations ].

  To reduce the
  risk of delayed GI transit and obstruction, patients should maintain
  adequate hydration during and in the days following a barium sulfate
  procedure. Consider the administration of laxatives.
  )
• Aspiration pneumonitis: Patients with history of food aspiration
  or with swallowing disorders are at increased risk. (
  5.4 Aspiration
  Pneumonitis

  The use of E-Z-PAQUE is contraindicated in patients at high risk
  of aspiration

  [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 E-Z-PAQUE. Discontinue administration
  of E-Z-PAQUE immediately if aspiration is suspected.
  )