Varibar Thin Honey

1 INDICATIONS AND USAGE VARIBAR THIN HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN HONEY 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 )

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 cramp ( 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

4 CONTRAINDICATIONS VARIBAR THIN HONEY 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 HONEY 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 HONEY ( 4 )

11 DESCRIPTION VARIBAR THIN HONEY (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm 3 , and the following chemical structure: VARIBAR THIN HONEY has a viscosity of 1500 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol. barium-sulfate-structure

2 DOSAGE AND ADMINISTRATION For oral use only – administer by syringe, spoon, or cup. The recommended dose is: Adults: 5 mL Pediatric patients: 1 to 3 mL During a single modified barium swallow examination, multiple doses may be administered Maximum cumulative dose: 30 mL ( 2 ) 2.1 Recommended Dosing The recommended dose of VARIBAR THIN HONEY administered orally by syringe, spoon, or cup is: Adults: 5 mL Pediatric patients: 1 to 3 mL During a single modified barium swallow examination, multiple doses of VARIBAR THIN HONEY may be administered, to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 30 mL. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days. 2.2 Important Administration Instructions For oral use only Advise patients to hydrate following the barium sulfate procedure.

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

20241107

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3 DOSAGE FORMS AND STRENGTHS Oral suspension: barium sulfate (40% w/v) supplied in either a multiple-dose plastic bottle or tube as a ready-to-use suspension for oral administration. Each bottle contains 250 mL of suspension; each tube contains 30 mL of suspension. Oral suspension: barium sulfate (40% w/v) supplied in a multiple-dose bottle or tube for oral administration ( 3 )

Varibar Thin Honey barium sulfate Barium Sulfate Barium Sulfate anhydrous citric acid carboxymethylcellulose sodium dimethicone 350 dimethicone 1000 glycerin modified corn starch (1-octenyl succinic anhydride) polysorbate 80 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate water xanthan gum 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.

NDA208143

Varibar Thin Honey

barium sulfate

32909-121

HUMAN PRESCRIPTION DRUG

ORAL

250 mL Varibar Thin Honey External Label Varibar Thin Honey External Label 10-23 CEEE203

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. August 2024 CLEE5-03

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary VARIBAR THIN HONEY 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 HONEY 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 HONEY 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 HONEY 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 HONEY 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 HONEY is supplied as a suspension in both a multiple-dose polyethylene bottle containing 250 mL and multiple-dose polyethylene tube containing 30 mL of barium sulfate (40 % w/v). Provided as: 12 x 250 mL bottles (NDC 32909-121-07); 24 x 30 mL tubes (NDC 32909-121-54) 16.2 Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from freezing. Once opened, VARIBAR THIN HONEY 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).