E-Z-HD (Page 2 of 2)
8.5 Geriatric Use
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.
11 DESCRIPTION
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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Due to its high atomic number, barium (the active ingredient in E-Z-HD) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.
12.3 Pharmacokinetics
Under physiological conditions, barium sulfate passes through the GI tract in an unchanged form and is absorbed only in pharmacologically insignificant amounts.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.
16 HOW SUPPLIED/STORAGE AND HANDLING
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).
17 PATIENT COUNSELING INFORMATION
After administration advise patients to:
- Maintain adequate hydration
- Seek medical attention for worsening of constipation or slow gastrointestinal passage
- Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty
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 | Operations |
CIMBAR PERFORMANCE MINERALS, INC. | 963805671 | API MANUFACTURE (32909-764) |
Establishment | |||
Name | Address | ID/FEI | Operations |
E-Z-EM Canada Inc | 204211163 | ANALYSIS (32909-764), MANUFACTURE (32909-764), PACK (32909-764), LABEL (32909-764) |
Revised: 02/2017 E-Z-EM Canada Inc
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