NDC 32909-187 E-z-paque

Barium Sulfate

NDC Product Code 32909-187

NDC 32909-187-02

Package Description: 12 BOTTLE, PLASTIC in 1 CARTON > 355 mL in 1 BOTTLE, PLASTIC

NDC Product Information

E-z-paque with NDC 32909-187 is a a human prescription drug product labeled by E-z-em Canada Inc. The generic name of E-z-paque is barium sulfate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: E-z-em Canada Inc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

E-z-paque Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BARIUM SULFATE .6 g/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Radiographic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • X-Ray Contrast Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: E-z-em Canada Inc
Labeler Code: 32909
FDA Application Number: NDA208143 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 11-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

E-z-paque Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1   Indications And Usage

Liquid E-Z-PAQUE is indicated for use in
single contrast radiographic examinations of the esophagus, stomach,
and small bowel to visualize the gastrointestinal (GI) tract in adult
and pediatric patients.

  • The
  • Optimal oral dose of Liquid E-Z-PAQUE will vary depending on the size
  • And anatomy of the patient and the procedure being performed. The
  • Recommended oral dose of Liquid E-Z-PAQUE:Adults: 150 to 750 mL (87 g to 435 g of barium sulfate,
  • Respectively). Volumes closer to 150 mL are recommended for examination
  • Of the esophagus and stomach and volumes up to 750 mL are recommended
  • For examination of the small bowelPediatric Patients: Adjust dose based on GI volumeFor examinations of the upper GI tract, administer a volume
  • Sufficient to fully distend the esophagus or stomach. For small bowel examinations:Age birth to less than 2 years: 30 mL to 75 mLAge 2 years to less than 17 years: 75 mL to 480 mL

2.2 Administration Instructions

  • For oral use onlyShake bottle vigorously for 30 seconds prior to oral administration
  • To fully suspend productAdminister undilutedEnsure patients have nothing by mouth for the following
  • Time period prior to the examination:Neonates and Infants < 3 months                 2 hoursInfants 3-12 months
  • 3 hours> 12 months of age
  • 4 hoursDiscard any unused suspensionEncourage patients to maintain hydration following the barium
  • Sulfate procedure

3   Dosage Forms And Strengths

Liquid E-Z-PAQUE oral suspension:
213 grams of barium sulfate supplied as a suspension (60 % w/v) in
a single-dose bottle.

4   Contraindications

  • Liquid E-Z-PAQUE is contraindicated in patients
  • With the following conditions:known or suspected perforation of the GI tractknown obstruction of the GI tracthigh risk of GI perforation such as those with a recent
  • 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 pelvishigh risk of aspiration such as those with prior aspiration,
  • Tracheo-esophageal fistula, or obtundationknown severe hypersensitivity to barium sulfate or any of
  • The excipients of Liquid E-Z-PAQUE

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 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.

5.2 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
(4)]. 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.

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 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 (8.4, 8.5)]. To reduce the
risk of delayed GI transit and obstruction, patients should maintain
adequate hydration following a barium sulfate procedure.

5.4 Aspiration Pneumonitis

The use of Liquid E-Z-PAQUE 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 Liquid E-Z-PAQUE. Discontinue
administration of Liquid E-Z-PAQUE 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 barium sulfate
suspension, monitor patients for potential intravasation when administering
barium sulfate.

5.6 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.

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 crampingSerious adverse reactions and fatalities include aspiration
  • Pneumonitis, barium sulfate impaction, intestinal perforation with
  • Consequent peritonitis and granuloma formation, vasovagal and syncopal
  • Episodes

8.1 Pregnancy

Risk SummaryLiquid
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 (12.3)].

8.2 Lactation

Risk SummaryLiquid
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 Pharmacology
(12.3).

8.4 Pediatric Use

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 (12.1)]. Safety and dosing recommendations in pediatric patients
are based on clinical experience [see Dosage and Administration
(2.1)].Liquid E-Z-PAQUE 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)].
Monitor pediatric patients with cystic fibrosis or Hirschsprung disease
for bowel obstruction after use [see Warnings and Precautions
(5.3)]

8.5 Geriatric Use

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.

11   Description

Liquid E-Z-PAQUE (barium sulfate) is a radiographic contrast agent
supplied as a white to lightly colored barium sulfate suspension (60%w/v)
for oral administration. The active ingredient barium sulfate is designated
chemically as BaSO4 with a molecular weight
of 233.4 g/mol, a density of 4.5 g/cm3,
and the following chemical structure:Liquid E-Z-PAQUE contains
the following excipients: carboxymethyl cellulose sodium, citric acid,
natural and artificial strawberry lemon cream flavor, polysorbate
80, potassium sorbate, purified water, saccharin sodium, simethicone
emulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthan
gum.

12.1 Mechanism Of Action

Due to its high atomic number, barium (the active ingredient in Liquid
E-Z-PAQUE) 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 gastrointestinal tract in an unchanged
form and is absorbed only in pharmacologically insignificant amounts.

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

How SuppliedLiquid E-Z-PAQUE (barium sulfate) is a suspension (60% w/v) supplied
as a unit dose in a single use HDPE plastic bottle containing 213
grams of barium sulfate in 355 mL.Provided as: 24 x 355 mL bottles (NDC 32909-186-02).Storage and HandlingStore at USP controlled room temperature 20 to 25°C (68
to 77° F). Protect from freezing.

17   Patient Counseling Information

  • After administration advise patients to:Maintain adequate hydrationSeek medical attention for worsening of constipation or
  • Slow gastrointestinal passageSeek medical attention for any delayed onset of hypersensitivity,
  • Such as: rash, urticaria, or respiratory difficultyManufactured forBracco Diagnostics Inc.Monroe Township, NJ 08831by EZEM Canada IncAnjou (Quebec) Canada H1J 2Z4

* Please review the disclaimer below.