Varibar Thin Liquid

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

4 CONTRAINDICATIONS VARIBAR THIN LIQUID is contraindicated in patients with: known or suspected perforation of the gastrointestinal (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 known or suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of VARIBAR THIN LIQUID Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR THIN LIQUID ( 4 )

2 DOSAGE AND ADMINISTRATION For oral use only– once reconstituted, administer by infant bottle, syringe, spoon, or cup. The recommended dose is: ● Adults: 5 mL ● Pediatric patients 6 months and older: 1 mL to 3 mL ● Pediatric patients younger than 6 months of age: 0.5 mL to 1 mL During a single modified barium swallow examination, multiple doses may be administered Maximum cumulative dose: 80 mL ( 2.1 ) Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions ( 2.2 ) 2.1 Recommended Dosing and Administration Instructions The recommended dose of reconstituted VARIBAR THIN LIQUID administered orally by infant bottle, syringe, spoon, or cup is: Adults: 5 mL Pediatric patients 6 months and older: 1 mL to 3 mL Pediatric patients younger than 6 months of age: 0.5 mL to 1 mL During a single modified barium swallow examination, multiple doses of VARIBAR THIN LIQUID may be administered, to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 80 mL. For oral use only Advise patients to hydrate following the barium sulfate procedure. 2.2 Instructions for Reconstitution The VARIBAR THIN LIQUID powder must be reconstituted prior to administration by a healthcare provider according to the following instructions: Add water to the fill line on the bottle label Replace the lid securely Invert the bottle and tap with fingers to mix the powder into the water Shake vigorously for 30 seconds. Let stand for 5 minutes Refill with water to the fill line on the bottle label and reshake thoroughly. Once reconstituted, write the discard after date on the immediate container label. After reconstitution, store in refrigerator at 2°C to 8°C (36ºF to 46ºF) for up to 72 hours. Reconstitution yields approximately 300 mL of VARIBAR THIN LIQUID oral suspension containing 0.4 grams of barium sulfate per mL (40% w/v) and should be homogeneous and white to lightly colored.

1 INDICATIONS AND USAGE VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN LIQUID is a radiopaque contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients ( 1 )

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in VARIBAR THIN LIQUID) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies. 12.2 Pharmacodynamics Barium sulfate is biologically inert and has no known pharmacological effects. 12.3 Pharmacokinetics Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

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3 DOSAGE FORMS AND STRENGTHS For oral suspension: 120 grams of barium sulfate supplied as a white to lightly colored powder (81% w/w) in a multiple-dose plastic bottle for reconstitution. For oral suspension: 120 g barium sulfate (81% w/w) supplied in a multiple-dose bottle for reconstitution ( 3 )

Varibar Thin Liquid barium sulfate Barium Sulfate Barium Sulfate anhydrous citric acid carboxymethylcellulose sodium dimethicone 1000 maltodextrin polysorbate 80 silicon dioxide sorbitol trisodium citrate dihydrate xylitol saccharin sodium

13 NONCLINICAL TOXICOLOGY 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.

NDA208036

Varibar Thin Liquid

barium sulfate

32909-105

HUMAN PRESCRIPTION DRUG

ORAL

Varibar ® Thin Liquid - Barium Sulfate for Suspension NDC: 32909-105-10 CLDAE03 April 2023 Varibar Thin Liquid - Internal Varibar Thin Liquid - External

11 DESCRIPTION VARIBAR THIN LIQUID (barium sulfate) is a radiographic contrast agent that is supplied as a white to lightly colored powder for suspension (81% w/w) with an apple aroma 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/cm 3 , and the following chemical structure: VARIBAR THIN LIQUID has a viscosity of <15 cPs when reconstituted and contains the following excipients: carboxymethylcellulose sodium, citric acid, maltodextrin, natural and artificial apple flavor, polysorbate 80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol. Barium Sulfate Chemical Structure

17 PATIENT COUNSELING INFORMATION After administration, advise patients to: Maintain adequate hydration [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )] . Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions ( 5.3 )] . Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions ( 5.1 )]. Rx Only Manufactured by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 For Bracco Diagnostics Inc. Monroe Township, NJ 08831 VARIBAR is a registered trademark of E-Z-EM, Inc.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary VARIBAR THIN LIQUID is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary VARIBAR THIN LIQUID is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to the drug. 8.4 Pediatric Use The efficacy of VARIBAR THIN LIQUID in pediatric patients is based on successful opacification of the pharynx during modified barium swallow examinations [see Clinical Pharmacology ( 12.1 )] . Safety and dosing recommendations in pediatric patients are based on clinical experience. VARIBAR THIN LIQUID is contraindicated in pediatric patients with trachea-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 )]. Monitor patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use [see Warnings and Precautions ( 5.3 )] . 8.5 Geriatric Use Clinical studies of VARIBAR THIN LIQUID 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.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VARIBAR THIN LIQUID is supplied as a white to lightly colored powder in a multiple-dose polyethylene bottle containing 120 grams of barium sulfate (81% w/w). Provided as: 24 x 148 g bottles (NDC 32909-105-10) 16.2 Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68° F to 77° F).