Included as part of the PRECAUTIONS section.
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
Administration of E-Z-HD may result in leakage of barium
at any level of the GI tract in the presence of conditions such as carcinomas,
GI fistula, inflammatory bowel disease, gastric or duodenal ulcer,
appendicitis, or diverticulitis, and in patients with a severe stenosis at any
level of the GI tract, especially if it is distal to the stomach. The barium
leakage has been associated with peritonitis and granuloma formation. The use
of E-Z-HD is contraindicated in patients at high risk of perforation of the GI
tract [see CONTRAINDICATIONS].
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 lead to 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, taking medications that delay GI motility, and constipation. 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.
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-HD. The use
of E-Z-HD is contraindicated in patients at high risk of aspiration [see
CONTRAINDICATIONS]. Discontinue administration of E-Z-HD immediately if
aspiration is suspected.
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 exceedingly uncommon after oral administration of a barium
sulfate suspension, monitor patients for potential intravasation when
administering barium sulfate.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No animal studies have been performed to evaluate the
carcinogenic potential of barium sulfate or potential effects on fertility.
Use In Specific Populations
E-Z-HD is not absorbed systemically following oral
administration, and maternal use is not expected to result in fetal exposure to
Risk Summary E-Z-HD is not absorbed systemically by the
mother following oral administration, and breastfeeding is not expected to
result in exposure of the infant to E-Z-HD.
Double-contrast radiographic examinations of the
esophagus, stomach and duodenum may be used in pediatric patients 12 years and
Clinical studies of E-Z-HD 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.