E-Z-Paque

E-Z-Paque is an FDA-registered drug product whose active ingredient is BARIUM SULFATE. It is labelled by E-Z-EM Canada Inc taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 32909-187, application NDA208143, label effective 20260415. It is one of 10 FDA drug label records sharing the active ingredient BARIUM SULFATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BARIUM SULFATE are most often described in connection with: liquid e-z-paque, single contrast, radiographic examinations, esophagus stomach, small bowel, gastrointestinal tract, pediatric patients, agent indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 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 barium sulfate procedure

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 )

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

FDA lists 10 drug label records with BARIUM SULFATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is E-Z-Paque used for?
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 …

Who makes E-Z-Paque?
E-Z-EM Canada Inc is the labeler of record for E-Z-Paque. 10 FDA label records share the active ingredient BARIUM SULFATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does E-Z-Paque come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is E-Z-Paque prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BARIUM SULFATE?
Yes. 10 FDA drug label records list BARIUM SULFATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has E-Z-Paque been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.