E-Z-PAQUE- barium sulfate powder, for suspension
E-Z-EM Canada Inc
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use E-Z-PAQUE safely and effectively. See full prescribing information for E-Z-PAQUE.
E-Z-PAQUE (barium sulfate) for oral suspension
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
E-Z-PAQUE is a radiographic contrast agent indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
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
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal tract (GI) in adult and pediatric patients.
For oral suspension: 169 g of barium sulfate supplied as a fine, white to lightly colored powder (96 % w/w) in a single-dose HDPE plastic bottle for reconstitution. The suspension can be reconstituted to a desired strength of 60, 70, 85, 100, or 115% w/v when prepared according to the corresponding fill line on the bottle. The reconstituted solution should be opaque, white to lightly-colored and free from particles.
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.
The use of E-Z-PAQUE is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of 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.
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, 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.
The use of 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 E-Z-PAQUE. Discontinue administration of E-Z-PAQUE immediately if aspiration is suspected.
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.
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 E-Z-PAQUE assess patients for a history of hereditary fructose intolerance and avoid use in these patients.
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
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)].
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 E-Z-PAQUE [see Clinical Pharmacology (12.3)].
The efficacy of E-Z-PAQUE in pediatric patients from birth to less than 17 years of age is based on successful opacification of the esophagus, stomach, duodenum and small bowel during radiologic examinations [see Clinical Pharmacology (12.1)]. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration (2.1)].
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)]. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions (5.3)]. Pediatric patients with hereditary fructose intolerance may develop severe symptoms with administration of E-Z-Paque; assess for this risk and avoid use in patients with hereditary fructose intolerance [see Warnings and Precautions (5.6)].
Clinical studies of E-Z-PAQUE 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.
E-Z-PAQUE (barium sulfate) is a radiographic contrast agent that is supplied as a fine, white to lightly colored powder for suspension (96 % w/w) 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:
E-Z-PAQUE contains excipients including: carrageenan, citric acid, natural and artificial natural and artificial strawberry flavor, natural and artificial vanilla flavor, pectin, polysorbate 80, propylene glycol, saccharin sodium, simethicone, sodium citrate, sorbitol, tragacanth and xanthan gum.
barium sulfate powder, for suspension
|Labeler - E-Z-EM Canada Inc (204211163)|
|Registrant - BRACCO DIAGNOSTICS INC (849234661)|
|E-Z-EM Canada Inc||204211163||MANUFACTURE(32909-750) , ANALYSIS(32909-750)|