E-z-hd

Barium Sulfate


E-z-em Canada Inc
Human Prescription Drug
NDC 32909-764
E-z-hd also known as Barium Sulfate is a human prescription drug labeled by 'E-z-em Canada Inc'. National Drug Code (NDC) number for E-z-hd is 32909-764. This drug is available in dosage form of Powder, For Suspension. The names of the active, medicinal ingredients in E-z-hd drug includes Barium Sulfate - 980 mg/g . The currest status of E-z-hd drug is Active.

Drug Information:

Drug NDC: 32909-764
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: E-z-hd
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Barium Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: E-z-em Canada Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Powder, For Suspension
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:BARIUM SULFATE - 980 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 11 Jan, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 23 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA208036
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:E-Z-EM Canada Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000180185
N0000010258
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:25BB7EKE2E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:X-Ray Contrast Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Radiographic Contrast Agent [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Radiographic Contrast Agent [EPC]
X-Ray Contrast Activity [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
32909-764-0124 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE18 Apr, 2016N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

E-z-hd barium sulfate barium sulfate barium sulfate acacia anhydrous citric acid dimethicone 1000 ethyl maltol polysorbate 80 saccharin sodium silicon dioxide trisodium citrate dihydrate sorbitol carrageenan sodium

Indications and Usage:

1 indications and usage 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. 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 )

Warnings and Cautions:

5 warnings and precautions emergency equipment and trained personnel should be immediately available for treatment of a serious hypersensitivity reaction ( 5.1 ) intra-abdominal leakage: caution is recommended in patient conditions like gi fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the gi tract ( 5.2 ) patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction caused by baroliths ( 5.3 ) aspiration: caution is recommended in patients with history of food aspiration and in patients with known swallowing disorders ( 5.4 ) e-z-hd is not intended for pediatric use from birth through 11 years of age ( 8.4 ) 5.1 hypersensitivity reactions 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 respi
ratory 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. 5.2 intra-abdominal barium leakage 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. 5.3 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, 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. 5.4 aspiration pneumonitis 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. 5.5 systemic embolization 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. 5.6 risk with hereditary fructose intolerance 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.

Dosage and Administration:

2 dosage and administration 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 ) must reconstitute supplied powder with water prior to use. see full prescribing information for reconstitution instructions ( 2.2 ) 2.1 recommended dosage 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. 2.2 instructions for reconstitution the 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 2.3 administration instructions administer the reconstituted e-z-hd for oral suspension immediately upon reconstitution to use with a straw, remove the adhesive label from top of the cap. remove cap and use straw to push out cap liner. replace cap discard any unused suspension advise patients to hydrate following the barium sulfate procedure

Dosage Forms and Strength:

3 dosage forms and strengths 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. for oral suspension: 334 grams of barium sulfate (98 % w/w) in a single-dose bottle for reconstitution( 3 )

Contraindications:

4 contraindications 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 known or suspected perforation of the gi tract ( 4 ) conditions associated to high risk of aspiration ( 4 ) conditions associated to high risk of gi perforation ( 4 ) known hypersensitivity to barium sulfate or any of the excipients of e-z-hd ( 4 )

Adverse Reactions:

6 adverse reactions 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 nausea, vomiting, diarrhea and abdominal cramping serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes 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

Use in Specific Population:

8 use in specific populations 8.1 pregnancy 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. 8.2 lactation 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. 8.4 pediatric use 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 )] 8.5 geriatric use c
linical 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.

Description:

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 baso 4 with a molecular weight of 233.43 g/mol, a density of 4.5 g/cm 3 , 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. barium-sulfate-structure

Clinical Pharmacology:

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.

Nonclinical Toxicology:

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.

How Supplied:

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).

Information for Patients:

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 cl80608 revised december 2021

Package Label Principal Display Panel:

Ez-hd labels ndc: 32909-764-01 e-z-hd-unit-label e-z-hd-external-label


Comments/ Reviews:

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