2.1 Recommended Dosage

The optimal oral dose of E-Z-PAQUE will vary depending on the size and anatomy of the patient and the procedure being performed. The recommended oral dose of reconstituted E-Z-PAQUE:

• Adults: 150 to 750 mL, 169 to 450 g barium sulfate, depending on the reconstituted concentration [see Dosage and Administration (2.2)].
  • Volumes closer to 150 mL are recommended for examination of the esophagus and stomach.
  • Volumes up to 750 mL are recommended for examination of the small bowel.
• Pediatric Patients: Adjust dose of reconstituted E-Z-PAQUE 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 Instructions for Reconstitution

The reconstituted concentration will vary, depending on the procedure being performed.

• A barium suspension up to 115% w/v is recommended for examinations of the esophagus and upper GI
• A barium suspension of 60% w/v is recommended for examinations of the small bowel.

Reconstitute the E-Z-PAQUE prior to administration according to the following instructions:

• Tap bottle on a hard surface (right side up) several times to compact the product in the bottle.
• Add water to the blue line marked ‘Initial Fill Line’ on the bottle.
• Replace cap securely on the bottle.
• Invert bottle and tap with fingers to mix contrast into the water.
• Shake vigorously for 30 seconds; wait 5 minutes.
• Add more water as needed to achieve the desired % w/v concentration using the fill lines marked on the bottle. Then, re-shake vigorously for 30 seconds.
• To use with straw, remove adhesive label on top of cap.
• Remove cap and use straw to push out cap liner; replace cap.

2.3 Administration Instructions

• Use immediately after reconstitution.
• 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.

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 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.

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, 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.

5.4 Aspiration Pneumonitis

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.

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 a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.

5.6 Risk with Hereditary Fructose Intolerance

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.

8.1 Pregnancy

Risk Summary

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 Summary

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)].

8.4 Pediatric Use

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)].

8.5 Geriatric Use

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.

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in 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 GI 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.