ADVERSE REACTIONS SECTION.

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 population of uncertain size, it is not always possible to reliably estimate their frequency or to establish causal relationship to drug exposure:Nausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes. 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.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. VARIBAR HONEY is contraindicated in patientswith:known or suspected perforation of the gastrointestinal (GI)tractknown obstruction of the GI tracthigh risk of GI perforation such as those with recentGI 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 pelvishigh risk of aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundationknown severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR HONEY. known or suspected perforation of the gastrointestinal (GI)tract. known obstruction of the GI tract. high risk of GI perforation such as those with recentGI 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 suspectedtracheo-esophageal fistula or obtundation. known severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR 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 oraspiration (4)Known hypersensitivity to barium sulfate or any of the excipientsof VARIBAR HONEY (4). 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 oraspiration (4). Known hypersensitivity to barium sulfate or any of the excipientsof VARIBAR HONEY (4).

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only administer by syringe or spoon. The recommended dose is:Adults: mLPediatric patients: to mLDuring single modified barium swallow examination, multiple doses may be administeredMaximum cumulative dose: 30 mL (2). Adults: mL. Pediatric patients: to mL. During 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 HONEY administered orally by syringe, spoon, or cup is:Adults: mLPediatric patients months of age and older: to mL During single modified barium swallow examination, multiple doses of VARIBAR 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.. The recommended dose of VARIBAR HONEY administered orally by syringe, spoon, or cup is:Adults: mLPediatric patients months of age and older: to mL Adults: mL. Pediatric patients months of age and older: to mL. During single modified barium swallow examination, multiple doses of VARIBAR 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 onlyAdvise patients to hydrate following the barium sulfate procedure.. For oral use only. Advise patients to hydrate following the barium sulfate procedure.

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELINGINFORMATION. 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 orslow gastrointestinal passage [see Warnings and Precautions(5.3)].Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty [see Warnings andPrecautions (5.1)].. Maintain adequate hydration [see Dosage and Administration(2.2) and Warnings and Precautions(5.3)].. Seek medical attention for worsening of constipation orslow gastrointestinal passage [see Warnings and Precautions(5.3)].. Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty [see Warnings andPrecautions (5.1)].

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosing. The recommended dose of VARIBAR HONEY administered orally by syringe, spoon, or cup is:Adults: mLPediatric patients months of age and older: to mL During single modified barium swallow examination, multiple doses of VARIBAR 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.. The recommended dose of VARIBAR HONEY administered orally by syringe, spoon, or cup is:Adults: mLPediatric patients months of age and older: to mL Adults: mL. Pediatric patients months of age and older: to mL. During single modified barium swallow examination, multiple doses of VARIBAR 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.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryVARIBAR HONEY is notabsorbed systemically following oral administration, and maternaluse is not expected to result in fetal exposure to the drug.. 8.2 Lactation. Risk SummaryVARIBAR HONEY is notabsorbed systemically by the mother following oral administration,and breastfeeding is not expected to result in exposure of the infantto the drug.. 8.4 PediatricUse. The efficacyof VARIBAR HONEY in pediatric patients above months of age is basedon successful opacification of the pharynx during modified bariumswallow examinations [see Clinical Pharmacology (12.1)]. Safety and dosing recommendationsin pediatric patients above months of age are based on clinicalexperience.VARIBARHONEY is contraindicated in pediatric patients with trachea-esophagealfistula [see Contraindications (4)]. Pediatric patients with history of asthma or foodallergies may be at increased risk for development of hypersensitivityreactions [see Warnings and Precautions (5. 1)]. Monitor patients with cysticfibrosis or Hirschsprung disease for bowel obstruction after use [see Warnings and Precautions (5.3)].. 8.5 GeriatricUse. Clinicalstudies of VARIBAR HONEY did not include sufficient numbers of subjectsaged 65 and over to determine whether they respond differently fromyounger subjects. Other reported clinical experience has not identifieddifferences 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 thegreater 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 trained personnel should be immediately available (5.1)Intra-abdominal leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract (5.2)Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction (5.3)Aspiration Pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration (5.4). Intra-abdominal leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract (5.2). Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction (5.3). Aspiration Pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration (5.4). 5.1 HypersensitivityReactions. Bariumsulfate preparations contain number of excipients, including naturaland artificial flavors and may induce serious hypersensitivity reactions.The manifestations include hypotension, bronchospasm and other respiratoryimpairments, and dermal reactions including rashes, urticaria anditching. history of bronchial asthma, atopy, food allergies, ora previous reaction to contrast agent may increase the risk forhypersensitivity reactions. Emergency equipment and trained personnelshould be immediately available for treatment of hypersensitivityreaction.. 5.2 Intra-abdominalBarium Leakage. The use of VARIBAR HONEY is contraindicated in patients at high riskof perforation of the GI tract [see Contraindications (4)]. Administration of VARIBAR HONEYmay result in leakage of barium from the GI tract in the presenceof conditions such as carcinomas, GI fistula, inflammatory bowel disease,gastric or duodenal ulcer, appendicitis, or diverticulitis, and inpatients with severe stenosis at any level of the GI tract, especiallyif it is distal to the stomach. The barium leakage has been associatedwith peritonitis and granuloma formation.. 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, impaired GI motility, electrolyte imbalance,dehydration, on low residue diet, taking medications that delayGI motility, constipation, pediatric patients with cystic fibrosisor Hirschsprung disease, and the elderly [see Use in SpecificPopulations (8.4, 8.5)]. To reduce the risk of delayedGI transit and obstruction, patients should maintain adequate hydrationafter the barium sulfate procedure.. 5.4 AspirationPneumonitis. Theuse of VARIBAR HONEY is contraindicated in patients with trachea-esophagealfistula [see Contraindications (4)]. Oral administration of barium is associated with aspirationpneumonitis, especially in patients with history of food aspirationor with compromised swallowing mechanism. Vomiting following oraladministration of barium sulfate may lead to aspiration pneumonitis.In patients at risk for aspiration,begin the procedure with small ingested volume of VARIBAR HONEY.Monitor the patient closely for aspiration, discontinue administrationof VARIBAR HONEY if aspiration is suspected, and monitor for developmentof aspiration pneumonitis.. 5.5 Systemic Embolization. Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract and enter the circulation as barium embolus 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 barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.