ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions have been identified fromspontaneous reporting or clinical studies of barium sulfate administeredorally. Because the reactions are reported voluntarily from populationof uncertain size, it is not always possible to reliably estimatetheir frequency or to establish causal relationship to drug exposureNausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Nausea, vomiting, diarrhea and abdominal cramping. Serious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. 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-1088or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. No animal studies have been performed to evaluatethe carcinogenic potential of barium sulfate or potential effectson fertility.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Due to its high atomic number, barium (the active ingredientin VARIBAR PUDDING) is opaque to x-rays and therefore acts as positivecontrast agent for radiographic studies.. 12.2 Pharmacodynamics. Barium sulfate is biologically inert and has no known pharmacologicaleffects.. 12.3 Pharmacokinetics. Under physiological conditions, barium sulfate passes throughthe gastrointestinal tract in an unchanged form and is absorbed onlyin small, pharmacologically insignificant amounts.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. VARIBAR PUDDING is contraindicated in patients with:- known or suspected perforationof the gastrointestinal (GI) tract;- known obstructionof the GI tract;- high risk of GI perforation such asthose with recent GI perforation, acute GI hemorrhage or ischemia,toxic megacolon, severe ileus, post GI surgery or biopsy, acute GIinjury or burn, or recent radiotherapy to the pelvis;-high risk for aspiration such as those with known or suspected tracheo-esophagealfistula or obtundation;- known hypersensitivity to bariumsulfate or any of the excipients of VARIBAR PUDDING.. VARIBAR PUDDING is contraindicatedin 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 excipientsof VARIBAR PUDDING (4). 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 excipientsof VARIBAR PUDDING (4).

DESCRIPTION SECTION.

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

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only administered by syringe or spoon (2.1)Adults: mLPediatric patients: 1-3 mL Multiple doses may be administeredMaximum cumulative dose 30 mL. For oral use only administered by syringe or spoon (2.1)Adults: mLPediatric patients: 1-3 mL Adults: mL. Pediatric patients: 1-3 mL. Multiple doses may be administered. Maximum cumulative dose 30 mL. 2.1 RecommendedDosing. The recommended oral dose of VARIBAR PUDDING delivered byoral syringe or spoon:Adults mLPediatric patients 1-3 mL During single modified barium swallow examination, multipledoses of VARIBAR PUDDING may be administered as appropriate, to assessthe 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 immediatecontainer label. Discard any unused product after 21 days.. The recommended oral dose of VARIBAR PUDDING delivered byoral syringe or spoon:Adults mLPediatric patients 1-3 mL Adults mL. Pediatric patients 1-3 mL. During single modified barium swallow examination, multipledoses of VARIBAR PUDDING may be administered as appropriate, to assessthe 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 immediatecontainer label. Discard any unused product after 21 days.. 2.2 ImportantAdministration Instructions. Advise patients to hydrate following the barium sulfateprocedure.Advise patient at risk for constipation or delayed gastrointestinaltransit to monitor for worsening of their condition after administrationof barium sulfate and seek medical attention if worsening and adviseusing laxatives to enhance gastrointestinal transit.. Advise patients to hydrate following the barium sulfateprocedure.. Advise patient at risk for constipation or delayed gastrointestinaltransit to monitor for worsening of their condition after administrationof barium sulfate and seek medical attention if worsening and adviseusing laxatives to enhance gastrointestinal transit.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGEFORMS AND STRENGTHS. Oral paste:barium sulfate (40% w/v) supplied in multiple-dose white polyethylenetube as ready-to-use paste for oral administration. Each tube contains230 mL of paste.. Oral paste: barium sulfate (40%w/v) in 230 mL multiple dose tube for oral administration (3).

GERIATRIC USE SECTION.

8.5 Geriatric Use. Clinical studies of VARIBAR PUDDING did not include sufficientnumbers of subjects aged 65 and over to determine whether they responddifferently from younger subjects. Other reported clinical experiencehas not identified differences in responses between the elderly andyounger patients. In general, dose selection for an elderly patientshould be cautious, usually starting at the low end of the dosingrange, reflecting the greater frequency of decreased hepatic, renal,or cardiac function, and of concomitant disease or other drug therapy.

HOW SUPPLIED SECTION.

16 HOWSUPPLIED/STORAGE AND HANDLING. VARIBAR PUDDING is supplied as paste ina multiple-dose polyethylene tube containing 230 mL of barium sulfate(40 w/v).Providedas: 12 230 mL tubes (NDC 32909-125-22)Store at USP Controlled Room Temperature20 to 25C (68 to 77 F). Protect from freezing.Once opened, VARIBAR PUDDING may be usedfor up to 21 days when stored at USP Controlled Room Temperature,20 to 25C (68 to 77 F).

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. VARIBAR PUDDING is indicated for modified barium swallow examinationsto evaluate the oral and pharyngeal function and morphology in adultand pediatric patients months of age and older.. VARIBAR PUDDING is radiographiccontrast agent indicated for use in modified barium swallow examinationsto evaluate the oral and pharyngeal function and morphology in adultand pediatric patients months of age and older (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. After administration, advise patients to:Maintain adequate hydration.Seek medical attention for worsening of constipation orslow gastrointestinal passage.Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty.Rx onlyManufactured forBraccoDiagnostics Inc.Monroe Township, NJ 08831byEZEM Canada IncAnjou (Quebec) Canada H1J 2Z4 VARIBAR(R) is registered trademark ofE-Z-EM, Inc.. Maintain adequate hydration.. Seek medical attention for worsening of constipation orslow gastrointestinal passage.. Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty.

LABOR & DELIVERY SECTION.

8.2Lactation. Risk SummaryVARIBAR PUDDING isnot absorbed systemically by the mother following oral administrationand breastfeeding is not expected to result in exposure of the infantto the drug. [see Clinical Pharmacology (12.3)].

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Due to its high atomic number, barium (the active ingredientin VARIBAR PUDDING) is opaque to x-rays and therefore acts as positivecontrast agent for radiographic studies.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. No animal studies have been performed to evaluatethe carcinogenic potential of barium sulfate or potential effectson fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

VaribarPudding LabelVaribar Pudding Tube. varibar-pudding-label. varibar-pudding-tube.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. The efficacy of VARIBAR PUDDING in pediatric patients above6 months of age is based on successful opacification of the pharynxduring modified barium swallow examinations [see ClinicalPharmacology (12.1)]. Safetyand dosing recommendations in pediatric patients above months ofage are based on clinical experience [see Indications (1), Dosage and Administration (2.1)].VARIBAR PUDDING is contraindicated in pediatricpatients with tracheo-esophageal fistula. [see Contraindications (4)].Pediatric patients with history of asthma or food allergies maybe at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Pediatric patients with cystic fibrosis or Hirschsprungdisease should be monitored for bowel obstruction after use [see Warnings and Precautions (5.3)].

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. Barium sulfate is biologically inert and has no known pharmacologicaleffects.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. Under physiological conditions, barium sulfate passes throughthe gastrointestinal tract in an unchanged form and is absorbed onlyin small, pharmacologically insignificant amounts.

PREGNANCY SECTION.

8.1Pregnancy. Risk SummaryVARIBAR PUDDING isnot absorbed systemically following oral administration, and maternaluse is not expected to result in fetal exposure to the drug. [see Clinical Pharmacology (12.3)].

SPL UNCLASSIFIED SECTION.

2.1 RecommendedDosing. The recommended oral dose of VARIBAR PUDDING delivered byoral syringe or spoon:Adults mLPediatric patients 1-3 mL During single modified barium swallow examination, multipledoses of VARIBAR PUDDING may be administered as appropriate, to assessthe 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 immediatecontainer label. Discard any unused product after 21 days.. The recommended oral dose of VARIBAR PUDDING delivered byoral syringe or spoon:Adults mLPediatric patients 1-3 mL Adults mL. Pediatric patients 1-3 mL. During single modified barium swallow examination, multipledoses of VARIBAR PUDDING may be administered as appropriate, to assessthe 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 immediatecontainer label. Discard any unused product after 21 days.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1Pregnancy. Risk SummaryVARIBAR PUDDING isnot absorbed systemically following oral administration, and maternaluse is not expected to result in fetal exposure to the drug. [see Clinical Pharmacology (12.3)] 8.2Lactation. Risk SummaryVARIBAR PUDDING isnot absorbed systemically by the mother following oral administrationand breastfeeding is not expected to result in exposure of the infantto the drug. [see Clinical Pharmacology (12.3)] 8.4 Pediatric Use. The efficacy of VARIBAR PUDDING in pediatric patients above6 months of age is based on successful opacification of the pharynxduring modified barium swallow examinations [see ClinicalPharmacology (12.1)]. Safetyand dosing recommendations in pediatric patients above months ofage are based on clinical experience [see Indications (1), Dosage and Administration (2.1)].VARIBAR PUDDING is contraindicated in pediatricpatients with tracheo-esophageal fistula. [see Contraindications (4)].Pediatric patients with history of asthma or food allergies maybe at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Pediatric patients with cystic fibrosis or Hirschsprungdisease 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 sufficientnumbers of subjects aged 65 and over to determine whether they responddifferently from younger subjects. Other reported clinical experiencehas not identified differences in responses between the elderly andyounger patients. In general, dose selection for an elderly patientshould be cautious, usually starting at the low end of the dosingrange, reflecting the greater frequency of decreased hepatic, renal,or cardiac function, and of concomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal leakage: May occur with conditions whichincrease the risk for perforation such as carcinomas, GI fistula,Inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,diverticulitis, or severe stenosis or obstructing lesions of the GItract (5.2)Obstruction: Patients should maintain adequate hydrationin days following barium sulfate procedure to avoid obstruction orimpaction by baroliths (5.3)Aspiration Pneumonitis: Aspiration may occur during themodified barium swallow examination, monitor the patient for aspiration(5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal leakage: May occur with conditions whichincrease the risk for perforation such as carcinomas, GI fistula,Inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,diverticulitis, or severe stenosis or obstructing lesions of the GItract (5.2). Obstruction: Patients should maintain adequate hydrationin days following barium sulfate procedure to avoid obstruction orimpaction by baroliths (5.3). Aspiration Pneumonitis: Aspiration may occur during themodified barium swallow examination, monitor the patient for aspiration(5.4). 5.1 HypersensitivityReactions. Barium sulfate preparations contain number of excipients, includingnatural and artificial flavors and may induce serious hypersensitivityreactions. The manifestations include: hypotension, bronchospasm andother respiratory impairments, and dermal reactions including rashes,urticaria, and itching. history of bronchial asthma, atopy, foodallergies, or previous reaction to contrast agent may increasethe risk for hypersensitivity reactions. Emergency equipment and trainedpersonnel should be immediately available for treatment of hypersensitivityreaction.. 5.2 Intra-abdominalBarium Leakage. Administration of VARIBAR PUDDING may result in leakage of bariumfrom the GI tract in the presence of conditions and ailments thatincrease the risk of perforation such as known carcinomas, GI fistula,inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,or diverticulitis, and in patients with severe stenosis at any levelof the gastrointestinal tract, especially if it is distal to the stomach.The barium leakage has been associated with peritonitis and granulomaformation. The use of VARIBAR PUDDING is contraindicated in patientsat high risk of perforation of the GI tract [see Contraindications(4)].. 5.3 DelayedGastrointestinal Transit and Obstruction. Orally administered barium sulfate may accumulateproximal to constricting lesion of the colon, causing obstructionor impaction with development of baroliths (inspissated barium associatedwith feces) and may lead to abdominal pain, appendicitis, bowel obstruction,or rarely perforation. Patients with the following conditions areat higher risk for developing obstruction or baroliths: severe stenosisat any level of the GI tract, with impaired gastrointestinal motility,electrolyte imbalance, dehydration, on low residue diet, takingmedications that delay GI motility, constipation, pediatric patientswith cystic fibrosis or Hirschsprung disease, and the elderly. [see Use in Specific Populations (8.4, 8.5)]. To reduce therisk of delayed GI transit and obstruction, patients should maintainadequate hydration after the barium sulfate procedure and considerthe administration of laxatives.. 5.4 Aspiration Pneumonitis. Oral administration of barium is associatedwith aspiration pneumonitis, especially in patients with historyof food aspiration or with compromised swallowing mechanism. Vomitingfollowing oral administration of barium sulfate may lead to aspirationpneumonitis. In patients at risk for aspiration, begin the procedurewith small ingested volume of VARIBAR PUDDING. The use of VARIBARPUDDING is contraindicated in patients with trachea-esophageal fistula [see Contraindications (4)]. Monitor the patient closely for aspiration, discontinue administrationof VARIBAR PUDDING if aspiration is suspected, and monitor for developmentof aspiration pneumonitis.. 5.5 SystemicEmbolization. Barium sulfate products may occasionally intravasate into the venousdrainage of the large bowel and enter the circulation as bariumembolus leading to potentially fatal complications which includesystemic and pulmonary embolism, disseminated intravascular coagulation,septicemia and prolonged severe hypotension. Although this complicationis exceedingly uncommon after oral administration of barium sulfatesuspension, monitor patients for potential intravasation when administeringbarium sulfate.