Drugplain

E-Z-Paque .6 g/mL

barium sulfate · SUSPENSION · E-Z-EM Canada Inc

No Recall History
Plain English

E-Z-Paque is a suspension containing barium sulfate at .6 g/mL, taken oral. Manufactured by E-Z-EM Canada Inc.

Key Facts

Brand Name
E-Z-Paque
Generic Name
barium sulfate
NDC Code (Product)
32909-187
Manufacturer
E-Z-EM Canada Inc
Strength
.6 g/mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
NDA208143
Drug Class
Radiographic Contrast Agent [EPC]
Marketing Start
11/01/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

renal failure18 reports
acute kidney injury17 reports
urticaria16 reports
chronic kidney disease15 reports
dyspnoea15 reports
diarrhoea14 reports
rash14 reports
pruritus13 reports
drug hypersensitivity12 reports
vomiting12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. Liquid E-Z-PAQUE is a radiographic contrast agent 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 ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adults: Recommended oral dose is 150 mL to 750 mL (87g to 435g of barium sulfate, respectively) ( 2.1 ) Pediatric patients: adjust dose based on relative GI volume ( 2.1 ) 2.1 Recommended Dosage 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 bowel Pediatric Patients: Adjust dose based on GI volume For 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 mL Age 2 years to less than 17 years: 75 mL to 480 mL 2.2 Administration Instructions For oral use only Shake bottle vigorously for 30 seconds prior to oral administration to fully suspend product Administer undiluted Ensure patients have nothing by mouth for the following time period prior to the examination: Neonates a…

Contraindications

4 CONTRAINDICATIONS Liquid E-Z-PAQUE is contraindicated in patients with 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 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 pelvis high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation known severe hypersensitivity to barium sulfate or any of the 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 or aspiration ( 4 ) Known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE ( 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

Frequently Asked Questions

What is E-Z-Paque used for?

E-Z-Paque contains barium sulfate. It is a suspension taken oral. Consult your doctor for specific uses.

Is E-Z-Paque a controlled substance?

E-Z-Paque is not classified as a controlled substance by the DEA.

What is the generic name for E-Z-Paque?

The generic name for E-Z-Paque is barium sulfate. There are 11 other brand versions of barium sulfate.

What is the NDC code for E-Z-Paque .6 g/mL?

The NDC (National Drug Code) for E-Z-Paque .6 g/mL is 32909-187, listed by E-Z-EM Canada Inc.

Product NDC

32909-187

Package NDC

32909-187-02

Other E-Z-Paque Dosages

Other Barium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)