E-z-paque suspension

1 indications and usage

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

Liquid E-Z-PAQUE is a radiographiccontrast agent indicated for use in single contrast radiographicexaminations of the esophagus, stomach, and small bowel to visualizethe gastrointestinal (GI) tract in adult and pediatric patients ( 1)

2 dosage and administration

  • Adults: Recommended oral dose is 150 mL to 750 mL (87gto 435g of barium sulfate, respectively) ( 2.1)
  • Pediatric patients: adjust dose based on relative GI volume( 2.1)

2.1 recommendeddosage

Theoptimal oral dose of Liquid E-Z-PAQUE will vary depending on the sizeand anatomy of the patient and the procedure being performed. Therecommended 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 examinationof the esophagus and stomach and volumes up to 750 mL are recommendedfor examination of the small bowel
  • Pediatric Patients: Adjust dose based on GI volume
    • For examinations of the upper GI tract, administer a volumesufficient to fully distend the esophagus or stomach.
    • For small bowel examinations:
      • Age birth to less than 2 years: 30 mL to 75 mL
      • Age 2 years to less than 17 years: 75 mL to 480 mL

2.2 administrationinstructions

  • For oral use only
  • Shake bottle vigorously for 30 seconds prior to oral administrationto fully suspend product
  • Administer undiluted
  • Ensure patients have nothing by mouth for the followingtime period prior to the examination:
    • Neonates and Infants < 3 months 2 hours
    • Infants 3-12 months 3 hours
    • > 12 months of age 4 hours
  • Discard any unused suspension
  • Encourage patients to maintain hydration following the bariumsulfate procedure

3 dosage forms and strengths

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

  • Oral suspension 213 g barium sulfate (60% w/v) ( 3)

4 contraindications

Liquid E-Z-PAQUE is contraindicated in patientswith the following conditions:

  • known or suspected perforation of the GI tract
  • known obstruction of the GI tract
  • high risk of GI perforation such as those with a recentGI 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
  • high risk of aspiration such as those with prior aspiration,tracheo-esophageal fistula, or obtundation
  • known severe hypersensitivity to barium sulfate or any ofthe excipients of Liquid E-Z-PAQUE
  • Known or suspected perforation of the GI tract ( 4)
  • Known obstruction of the GI tract ( 4)
  • Conditions associated with high risk of GI perforation oraspiration ( 4)
  • Known severe hypersensitivity to barium sulfate or any ofthe excipients of Liquid E-Z-PAQUE ( 4)

5 warningsand precautions

  • Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available ( 5.1)
  • Intra-abdominal barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract ( 5.2)
  • Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following a barium sulfate procedure toavoid obstruction or impaction ( 5.3)
  • Aspiration pneumonitis: Patients with history of foodaspiration or with swallowing disorders are at increased risk ( 5.4)

5.1 hypersensitivityreactions

Barium sulfate preparations contain a number of excipients, includingnatural and artificial flavors and may induce serious hypersensitivityreactions. The manifestations include hypotension, bronchospasm andother respiratory impairments, dermal reactions including rashes,urticaria and itching. A history of bronchial asthma, atopy or aprevious reaction to a contrast agent may increase the risk for hypersensitivityreactions. Emergency equipment and trained personnel should be immediatelyavailable for treatment of a hypersensitivity reaction.

5.2 intra-abdominalbarium leakage

The use of Liquid E-Z-PAQUE is contraindicated in patients at highrisk of perforation of the GI tract [see Contraindications( 4)].Administration of LiquidE-Z-PAQUE may result in leakage of barium from the GI tract in thepresence of conditions such as carcinomas, GI fistula, inflammatorybowel 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 associatedwith peritonitis and granuloma formation.

5.3 delayedgastrointestinal transit and obstruction

Orally administered barium sulfate may accumulateproximal to a constricting lesion of the colon, causing obstructionor impaction with development of baroliths (inspissated barium associatedwith feces) and may cause abdominal pain, appendicitis, bowel obstruction,or rarely perforation. Patients with the following conditions areat higher risk for developing obstruction or baroliths: severe stenosisat 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 therisk of delayed GI transit and obstruction, patients should maintainadequate hydration following a barium sulfate procedure.

5.4 aspirationpneumonitis

The use of Liquid E-Z-PAQUE is contraindicated in patients at highrisk of aspiration [see Contraindications ( 4)]. Oral administration of bariumis associated with aspiration pneumonitis, especially in patientswith a history of food aspiration or with compromised swallowing mechanism.Vomiting following oral administration of barium sulfate may leadto aspiration pneumonitis. In patients at risk for aspiration, beginthe procedure with a small ingested volume of Liquid E-Z-PAQUE. Discontinueadministration of Liquid E-Z-PAQUE immediately if aspiration is suspected.

5.5 systemicembolization

Barium sulfate products may occasionally intravasate into the venousdrainage of the large bowel and enter the circulation as a "bariumembolus" leading to potentially fatal complications which includesystemic and pulmonary embolism, disseminated intravascular coagulation,septicemia and prolonged severe hypotension. Although this complicationis exceedingly uncommon after oral administration of barium sulfatesuspension, monitor patients for potential intravasation when administeringbarium sulfate.

5.6 riskwith hereditary fructose intolerance

Liquid E-Z-PAQUE contains sorbitol whichmay cause severe symptoms if ingested by patients with hereditaryfructose intolerance. Severe symptoms may include the following:vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia,and kidney failure. Before administration of Liquid E-Z-PAQUE assesspatients for a history of hereditary fructose intolerance and avoiduse in these patients.

6 adverse reactions

The following adverse reactions have beenidentified from spontaneous reporting or clinical studies of bariumsulfate administered orally. Because the reactions are reported voluntarilyfrom a population of uncertain size, it is not always possible toreliably estimate their frequency or to establish a causal relationshipto drug exposure:

  • Nausea, vomiting, diarrhea and abdominal cramping
  • Serious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes

Common adverse reactions includenausea, 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-1088or www.fda.gov/medwatch

8 use in specific populations

8.1 pregnancy

Risk Summary
LiquidE-Z-PAQUE is not absorbed systemically following oral administration,and maternal use is not expected to result in fetal exposure to thedrug [see Clinical Pharmacology ( 12.3)].

8.2 lactation

Risk Summary
LiquidE-Z-PAQUE is not absorbed systemically by the mother following oraladministration, and breastfeeding is not expected to result in exposureof the infant to Liquid E-Z-PAQUE [see Clinical Pharmacology( 12.3).

8.4 pediatricuse

The efficacyof Liquid E-Z-PAQUE in pediatric patients from birth to less than17 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 patientsare based on clinical experience [see Dosage and Administration( 2.1)].

Liquid E-Z-PAQUE is contraindicated in pediatricpatients with tracheo-esophageal fistula. [see Contraindications( 4)].Pediatric patientswith a history of asthma or food allergies may be at increased riskfor development of hypersensitivity reactions [ see Warningsand Precautions ( 5.1)].Monitor pediatric patients with cystic fibrosis or Hirschsprung diseasefor bowel obstruction after use [see Warnings and Precautions( 5.3)]

8.5 geriatricuse

Clinicalstudies of Liquid E-Z-PAQUE do not include sufficient numbers of subjectsaged 65 and over to determine whether they respond differently fromyounger subjects. Other reported clinical experience has not identifieddifferences 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 thegreater frequency of decreased hepatic, renal, or cardiac function,and of concomitant disease or other drug therapy.

11description

Liquid E-Z-PAQUE (barium sulfate) is a radiographic contrast agentsupplied as a white to lightly colored barium sulfate suspension (60%w/v)for oral administration. The active ingredient barium sulfate is designatedchemically as BaSO 4with a molecular weightof 233.4 g/mol, a density of 4.5 g/cm 3,and the following chemical structure:

barium-sulfate-structure

Liquid E-Z-PAQUE containsthe following excipients: carboxymethyl cellulose sodium, citric acid,natural and artificial strawberry lemon cream flavor, polysorbate80, potassium sorbate, purified water, saccharin sodium, simethiconeemulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthangum.

12 clinical pharmacology

12.1 mechanismof action

Due to its high atomic number, barium (the active ingredient in LiquidE-Z-PAQUE) is opaque to x-rays and therefore acts as a positive contrastagent for radiographic studies.

12.3 pharmacokinetics

Under physiological conditions,barium sulfate passes through the gastrointestinal tract in an unchangedform and is absorbed only in pharmacologically insignificant amounts.

13 nonclinical toxicology

13.1 carcinogenesis,mutagenesis, impairment of fertility

No animal studies have been performed toevaluate the carcinogenic potential of barium sulfate or potentialeffects on fertility.

16 how supplied/storage and handling

How Supplied
Liquid E-Z-PAQUE (barium sulfate) is a suspension (60% w/v) suppliedas a unit dose in a single use HDPE plastic bottle containing 213grams of barium sulfate in 355 mL.

Provided as: 24 x 355 mL bottles (NDC 32909-186-02).

Storage and Handling
Store at USP controlled room temperature 20 to 25C (68to 77 F). Protect from freezing.

17 patient counseling information

After administration advise patients to:

  • Maintain adequate hydration
  • Seek medical attention for worsening of constipation orslow gastrointestinal passage
  • Seek medical attention for any delayed onset of hypersensitivity,such as: rash, urticaria, or respiratory difficulty

Manufactured for
Bracco Diagnostics Inc.
Monroe Township, NJ 08831
by EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4

Ingredients and appearance - Product information

E-z-paque suspension- Barium sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 32909-186
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Barium sulfate ( UNII: 25BB7EKE2E)( Barium sulfate - UNII: 25BB7EKE2E ) 0.6 gin 1 mL

Inactive Ingredients

Ingredient Name Code
Carboxymethylcellulose sodium ( UNII: K679OBS311)
Anhydrous citric acid ( UNII: XF417D3PSL)
Dimethicone 350 ( UNII: 2Y53S6ATLU)
Dimethicone 1000 ( UNII: MCU2324216)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Potassium sorbate ( UNII: 1VPU26JZZ4)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium benzoate ( UNII: OJ245FE5EU)
Trisodium citrate dihydrate ( UNII: B22547B95K)
Sorbitol ( UNII: 506T60A25R)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE Flavor STRAWBERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA208143 USA

Labeler - E-Z-EM Canada Inc( 204211163)

Establishment

Name ID/FEI Business Operations
E-Z-EM Canada Inc 204211163 PACK( 32909-186), MANUFACTURE( 32909-186), LABEL( 32909-186), ANALYSIS( 32909-186)

Package label.principal display panel



LIQUID E-Z-PAQUE 355 mL Carton and Label
NDC: 32909-186-02