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
The use of Liquid E-Z-PAQUE is contraindicated in
patients at high risk of perforation of the GI tract [see CONTRAINDICATIONS].
Administration 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 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 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
The 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.
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 barium
sulfate suspension, monitor patients for potential intravasation when
administering barium sulfate.
Risk With Hereditary Fructose Intolerance
Liquid E-Z-PAQUE 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 Liquid E-Z-PAQUE assess patients for a history of hereditary
fructose intolerance and avoid use in these patients.
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
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 [see CLINICAL PHARMACOLOGY].
Liquid E-Z-PAQUE is not absorbed systemically
by the mother following oral administration, and breastfeeding is not expected
to result in exposure of the infant to Liquid E-Z-PAQUE [see CLINICAL
The efficacy of Liquid E-Z-PAQUE in pediatric patients
from birth to less than 17 years of age is based on successful opacification of
the esophagus, stomach, and small bowel during single contrast radiographic
procedures [see CLINICAL PHARMACOLOGY]. Safety and dosing
recommendations in pediatric patients are based on clinical experience [see
DOSAGE AND ADMINISTRATION].
Liquid E-Z-PAQUE is contraindicated in pediatric patients
with tracheo-esophageal fistula. [see CONTRAINDICATIONS]. Pediatric
patients with a history of asthma or food allergies may be at increased risk
for development of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Monitor pediatric patients with cystic fibrosis or Hirschsprung disease for
bowel obstruction after use [see WARNINGS AND PRECAUTIONS]
Clinical studies of Liquid E-Z-PAQUE do 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.