E-z-hd
(Barium Sulfate)E-Z-Hd Prescribing Information
Warnings and Precautions (E-Z-HD contains sorbitol which may cause severe reactions if ingested by patients with hereditary fructose intolerance, such as: vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of E-Z-HD assess patients for a history of hereditary fructose intolerance and avoid use in these patients. | 2/2017 |
E-Z-HD is indicated for use in double-contrast
radiographic examinations of the esophagus, stomach and duodenum to
help visualize the gastrointestinal (GI) tract in patients 12 years
and older.
- Recommended reconstituted oral dose for adults and pediatric
patients 12 years and older is between 65 mL to 135 mL (155 to 321
grams of barium sulfate, respectively) ()2.1 Recommended
DosageThe
recommended dose of reconstituted E-Z-HD for adults and pediatric
patients 12 years and olderis between 65 and
135 mL given orally (155 to 321 grams of barium sulfate, respectively).
Volumes closer to 65 mL are recommended for the examination of the
esophagus and volumes up to 135 mL are recommended for examination
of the entire upper GI tract. - Must reconstitute supplied powder with water prior to use.
See Full Prescribing Information for reconstitution instructions
()2.2 Instructions
for ReconstitutionThe E-Z-HD powder must be reconstituted prior
to administration by a healthcare provider according to the following
instructions:- Accurately measure 65 mL of water and add this water to
the bottle containing the supplied E-Z-HD powder - Replace cap securely on bottle and shake vigorously for
30 seconds - Wait 5 minutes and re-shake bottle thoroughly. Reconstitution
yields approximately 140 mL of E-Z-HD for oral suspension containing
2.38 grams of barium sulfate per mL
- Accurately measure 65 mL of water and add this water to
For oral suspension: 334 grams
of barium sulfate supplied as a fine, white to lightly colored powder
(98 % w/w) in a single-dose HDPE plastic bottle for reconstitution.
The suspension is 238% w/v when reconstituted and should be homogeneous
and white to lightly colored.
Risk Summary
E-Z-HD is not absorbed systemically following
oral administration, and maternal use is not expected to result in
fetal exposure to the drug.
E-Z-HD is contraindicated in patients:
- Known or suspected perforation of the GI tract
- Known obstruction of the GI tract
- At high risk of GI perforation such as those with a recent
prior 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 - At high risk of aspiration such as those with prior aspiration,
tracheo-esophageal fistula, or obtundation - With known severe hypersensitivity to barium sulfate or
any of the E-Z-HD excipients