Varibar Pudding

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 at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

4 CONTRAINDICATIONS VARIBAR PUDDING 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 for aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; - known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING. VARIBAR PUDDING is contraindicated in patients with: Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Conditions associated with high risk for GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Patients with trachea-esophageal fistula ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING ( 4 )

11 DESCRIPTION VARIBAR PUDDING (barium sulfate) is a radiographic contrast agent that is supplied as a 40 % w/v ready to use paste with a vanilla aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol and the following chemical structure: VARIBAR PUDDING has a viscosity of 5000 cPs and contains the following excipients: artificial vanilla flavor, carboxymethylcellulose sodium, citric acid, ethyl vanillin, glycerin, maltodextrin, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, xanthan gum, and xylitol. barium-sulfate-structure

2 DOSAGE AND ADMINISTRATION For oral use only – administered by syringe or spoon ( 2.1 ) Adults: 5 mL Pediatric patients: 1-3 mL Multiple doses may be administered Maximum cumulative dose : 30 mL 2.1 Recommended Dosing The recommended oral dose of VARIBAR PUDDING delivered by oral syringe or spoon: Adults 5 mL Pediatric patients 1-3 mL During a single modified barium swallow examination, multiple doses of VARIBAR PUDDING may be administered as appropriate, to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 30 mL oral. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days. 2.2 Important Administration Instructions Advise patients to hydrate following the barium sulfate procedure. Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.

1 INDICATIONS AND USAGE VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older ( 1 )

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in VARIBAR PUDDING) 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.

12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in VARIBAR PUDDING) 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 Oral paste: barium sulfate (40% w/v) supplied in a multiple-dose white polyethylene tube as a ready-to-use paste for oral administration. Each tube contains 230 mL of paste. Oral paste: barium sulfate (40% w/v) in a 230 mL multiple dose tube for oral administration ( 3 )

Varibar Pudding Barium Sulfate Barium Sulfate Barium Sulfate ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM DIMETHICONE 350 DIMETHICONE 1000 ETHYL VANILLIN GLYCERIN MALTODEXTRIN POLYSORBATE 80 POTASSIUM SORBATE SACCHARIN SODIUM SILICON DIOXIDE SODIUM BENZOATE WATER XANTHAN GUM XYLITOL

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.

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.

NDA208844

Varibar Pudding

Barium Sulfate

32909-125

HUMAN PRESCRIPTION DRUG

ORAL

Varibar Pudding Label Varibar Pudding Tube varibar-pudding-label varibar-pudding-tube

17 PATIENT COUNSELING INFORMATION After administration, advise patients to: Maintain adequate hydration. Seek medical attention for worsening of constipation or slow gastrointestinal passage. Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty. Rx only Manufactured for Bracco Diagnostics Inc. Monroe Township, NJ 08831 by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 VARIBAR ® is a registered trademark of E-Z-EM, Inc. Revised: December 2022 CL87D02

8.5 Geriatric Use Clinical studies of VARIBAR PUDDING 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

8.2 Lactation Risk Summary VARIBAR PUDDING 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. [see Clinical Pharmacology ( 12.3 )]

8.4 Pediatric Use The efficacy of VARIBAR PUDDING in pediatric patients above 6 months of age 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 above 6 months of age are based on clinical experience [see Indications ( 1 ), Dosage and Administration ( 2.1 )] . VARIBAR PUDDING 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 )] .

8.1 Pregnancy Risk Summary VARIBAR PUDDING 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 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary VARIBAR PUDDING 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 VARIBAR PUDDING 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. [see Clinical Pharmacology ( 12.3 )] 8.4 Pediatric Use The efficacy of VARIBAR PUDDING in pediatric patients above 6 months of age 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 above 6 months of age are based on clinical experience [see Indications ( 1 ), Dosage and Administration ( 2.1 )] . VARIBAR PUDDING 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 )] . 8.5 Geriatric Use Clinical studies of VARIBAR PUDDING 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 VARIBAR PUDDING is supplied as a paste in a multiple-dose polyethylene tube containing 230 mL of barium sulfate (40 % w/v). Provided as: 12 X 230 mL tubes (NDC 32909-125-22) Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from freezing. Once opened, VARIBAR PUDDING may be used for up to 21 days when stored at USP controlled room temperature, 20°C to 25°C (68°F to 77°F).