BARIUM: 412 Adverse Event Reports & Safety Profile

DESCRIPTION LIQUID POLIBAR PLUS ® Barium Sulfate Suspension (105% w/v, 58% w/w) is a barium sulfate suspension for oral and rectal administration.

Each

100 mL contains 105 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO 4 . Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.

Inactive

Ingredients acacia, citric acid, hydrochloric acid, natural and artificial vanilla flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium carrageenan, sodium citrate, sorbitol solution and xanthan gum.

AND USAGE 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. 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 )

AND ADMINISTRATION Adults: Recommended reconstituted oral dose is between 150 – 750 mL ( 2.1 ) Pediatric patients: adjust reconstituted dose based on relative GI volume ( 2.1 ) Must reconstitute supplied powder with water prior to use.

See Full Prescribing

Information for reconstitution instructions ( 2.2 )

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 <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.2 )]</span> . 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 &lt; 3 months 2 hours Infants 3-12 months 3 hours &gt; 12 months of age 4 hours Discard any unused suspension. Encourage patients to maintain hydration following the barium sulfate procedure.

E-Z-DISK is contraindicated in patients with: Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Warnings and Precautions ( 5.1 )] Known, suspected, or high risk of perforation of the GI tract such as patients with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, recent GI surgery or biopsy, acute GI injury, or recent radiotherapy to the pelvis [see Warnings and Precautions ( 5.2 )] Known obstruction of the GI tract [see Warnings and Precautions ( 5.3 )] High risk of aspiration such as patients with known or suspected tracheoesophageal fistula or obtundation [see Warnings and Precautions ( 5.4 )] Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK ( 4 ) Known or suspected perforation of the gastrointestinal (GI) tract or conditions associated with high risk of GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of aspiration ( 4 )

REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Intra-abdominal Barium Leakage [see Warnings and Precautions ( 5.2 )] Baroliths and Bowel Obstruction [see Warnings and Precautions ( 5.3 )]

Aspiration

Pneumonitis [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of E-Z-DISK or other barium sulfate products were identified in postmarketing reports or published clinical studies. Because some of these 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: Cardiovascular disorders : Vasovagal and syncopal episodes Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping Respiratory disorders : Aspiration pneumonitis Adverse Reactions in Pediatric Patients No additional safety signals have been reported in pediatric patients aged 12 years and older. 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

AND PRECAUTIONS Emergency equipment and trained personnel should be immediately available for treatment of a serious hypersensitivity reaction ( 5.1 ) Intra-abdominal leakage: Caution is recommended in patient conditions like GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction caused by baroliths ( 5.3 ) Aspiration: Caution is recommended in patients with history of food aspiration and in patients with known swallowing disorders ( 5.4 ) E-Z-HD is not intended for pediatric use from birth through 11 years of age ( 8.4 )

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-HD is contraindicated in patients at high risk of perforation of the GI tract <span class="opacity-50 text-xs">[see Contraindications ( 4 )]</span>. Administration of E-Z-HD 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, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The 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 lead to 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, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.4 , 8.5 )]</span> . 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-HD is contraindicated in patients at high risk of aspiration <span class="opacity-50 text-xs">[see Contraindications ( 4 )]</span> . 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-HD. Discontinue administration of E-Z-HD 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 &quot;barium embolus&quot; 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-HD contains sorbitol which may cause severe reactions if ingested by patients with hereditary fructose intolerance, such as: vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of E-Z-HD assess patients for a history of hereditary fructose intolerance and avoid use in these patients.

PRECAUTIONS General Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease. Ingestion of this product is not recommended in patients with a history of food aspiration. If barium studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. If this product is aspirated into the larynx, further administration should be immediately discontinued. After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose, following completion of the examination may also be required. These mild laxatives are recommended on a routine basis and in patients with a history of constipation unless contraindicated.

Oral Administration

Use with caution in patient with complete or nearly complete obstruction of the gastrointestinal tract.

Rectal Administration

Use with caution when obstructive lesions of the colon are suspected. Care should be taken to minimize the amount of barium sulfate allowed to flow proximal to obstructive lesions of the colon. When used rectally, care must be taken during insertion of the enema tip into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Information for Patients Before administration of this product patients should be instructed to: Inform their physician if they are pregnant. Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see PRECAUTIONS - General ). Inform their physician about any other medications they are currently taking.

Drug Interactions

The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered. Usage in Pregnancy Radiation is known to cause harm to the unborn fetus exposed in utero . Therefore, radiographic procedures should only be used when, in the judgement of the physician, their use is deemed essential to the welfare of the pregnant patient.

Nursing Mothers

Barium sulfate products may be used during lactation.

Drug Interactions The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.

ACTIVE INGREDIENTS: Echinacea (Angustifolia) 3X, Collinsonia Canadensis 3X, 12X, Phytolacca Decandra 4X, Kali Iodatum 6X, Pinus Sylvestris 6X, Pix Liquida 6X, Ferrum Phosphoricum 8X, Aesculus Hippocastanum 12X, Baryta Carbonica 12X, Berberis Vulgaris 12X, Calcarea Carbonica 12X, Calcarea Phosphorica 12X, Causticum 12X, Hepar Sulphuris Calcareum 12X, Kreosotum 12X, Lycopodium Clavatum 12X, Mercurius Solubilis 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Silicea 12X, Stellaria Media 12X, Sulphur 12X, Terebinthina 12X, Thuja Occidentalis 12X, Bufo Rana 14X.

Inactive Ingredients: carboxymethylcellulose sodium, citric acid, ethyl vanillin, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, simethicone emulsion, sodium citrate, and sorbitol solution.