E-z-paque
(Barium Sulfate)E-Z-Paque Prescribing Information
Liquid E-Z-PAQUE is indicated for use in
single contrast radiographic examinations of the esophagus, stomach,
and small bowel to visualize the gastrointestinal (GI) tract in adult
and pediatric patients.
- Adults: Recommended oral dose is 150 mL to 750 mL (87g
to 435g of barium sulfate, respectively) ()2.1 Recommended
DosageThe
optimal oral dose of Liquid E-Z-PAQUE will vary depending on the size
and anatomy of the patient and the procedure being performed. The
recommended oral dose of Liquid E-Z-PAQUE:- Adults: 150 to 750 mL (87 g to 435 g of barium sulfate,
respectively). Volumes closer to 150 mL are recommended for examination
of the esophagus and stomach and volumes up to 750 mL are recommended
for examination of the small bowel - Pediatric Patients: Adjust dose 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
- For examinations of the upper GI tract, administer a volume
- Adults: 150 to 750 mL (87 g to 435 g of barium sulfate,
- Pediatric patients: adjust dose based on relative GI volume
()2.1 Recommended
DosageThe
optimal oral dose of Liquid E-Z-PAQUE will vary depending on the size
and anatomy of the patient and the procedure being performed. The
recommended oral dose of Liquid E-Z-PAQUE:- Adults: 150 to 750 mL (87 g to 435 g of barium sulfate,
respectively). Volumes closer to 150 mL are recommended for examination
of the esophagus and stomach and volumes up to 750 mL are recommended
for examination of the small bowel - Pediatric Patients: Adjust dose 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
- For examinations of the upper GI tract, administer a volume
- Adults: 150 to 750 mL (87 g to 435 g of barium sulfate,
Liquid E-Z-PAQUE oral suspension:
213 grams of barium sulfate supplied as a suspension (60 % w/v) in
a single-dose bottle.
Risk Summary
Liquid
E-Z-PAQUE is not absorbed systemically following oral administration,
and maternal use is not expected to result in fetal exposure to the
drug
12.3 PharmacokineticsUnder physiological conditions,
barium sulfate passes through the gastrointestinal tract in an unchanged
form and is absorbed only in pharmacologically insignificant amounts.
Liquid E-Z-PAQUE 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 prior aspiration,
tracheo-esophageal fistula, or obtundation - known severe hypersensitivity to barium sulfate or any of
the excipients of Liquid E-Z-PAQUE
- Hypersensitivity reactions: Emergency equipment and trained
personnel should be immediately available ()5.1 Hypersensitivity
ReactionsBarium 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 LeakageThe use of Liquid E-Z-PAQUE is contraindicated in patients at high
risk of perforation of the GI tract[see ContraindicationsAdministration of Liquid
].
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 ()5.3 Delayed
Gastrointestinal Transit and ObstructionOrally 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 or 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 following a barium sulfate procedure. - Aspiration pneumonitis: Patients with history of food
aspiration or with swallowing disorders are at increased risk ()5.4 Aspiration
PneumonitisThe use of Liquid 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 Liquid E-Z-PAQUE. Discontinue
administration of Liquid E-Z-PAQUE immediately if aspiration is suspected.