E-Z-HD by is a Prescription medication manufactured, distributed, or labeled by E-Z-EM Canada Inc, BRACCO DIAGNOSTICS INC, CIMBAR PERFORMANCE MINERALS, INC.. Drug facts, warnings, and ingredients follow.
Warnings and Precautions (5.6) | 2/2017 |
E-Z-HD, a radiographic contrast agent, is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal (GI) tract in patients 12 years and older (1)
For oral suspension: 334 grams of barium sulfate (98 % w/w) in a single-dose bottle for reconstitution(3)
Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping (6)
To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2017
The 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.
The E-Z-HD powder must be reconstituted prior to administration by a healthcare provider according to the following instructions:
E-Z-HD is contraindicated in patients:
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.
The use of E-Z-HD is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of E-Z-HD 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, 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.
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, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly [see Use in Specific Populations (8.4, 8.5)]. 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.
The use of E-Z-HD is contraindicated in patients at high risk of aspiration [see Contraindications (4)]. 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. 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.
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.
The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure
E-Z-HD is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.
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 older.
E-Z-HD is contraindicated in pediatric patients with tracheo-esophageal fistula. [see Contraindications (4)]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions (5.3)]
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.
E-Z-HD (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (98 % w/w) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.43 g/mol, a density of 4.5 g/cm3, and the following chemical structure:
E-Z-HD contains excipients including: acacia, artificial cherry flavor, artificial strawberry flavor, carrageenan, citric acid, ethyl maltol, polysorbate 80, saccharin sodium, simethicone, sodium citrate, and sorbitol.
16.1 How Supplied
E-Z-HD (barium sulfate)
for suspension, is supplied as a fine, white to lightly colored powder
(98 % w/w) in a single-dose HDPE plastic bottle containing 334 grams
of barium sulfate.
Provided as: 24 bottles per pack (NDC: 32909-764-01)
16.2 Storage and Handling
Store at USP controlled room temperature, 20 to 25°C (68 to 77°
F).
After administration advise patients to:
Manufactured by
EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4
For
Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Revised February 2017
E-Z-HD
barium sulfate powder, for suspension |
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Labeler - E-Z-EM Canada Inc (204211163) |
Registrant - BRACCO DIAGNOSTICS INC (849234661) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
CIMBAR PERFORMANCE MINERALS, INC. | 963805671 | API MANUFACTURE(32909-764) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
E-Z-EM Canada Inc | 204211163 | ANALYSIS(32909-764) , MANUFACTURE(32909-764) , PACK(32909-764) , LABEL(32909-764) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
E-Z-HD 74061944 not registered Dead/Abandoned |
E-Z-EM, Inc. 1990-05-23 |