DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGEFORMS AND STRENGTHS. Oral suspension: barium sulfate (40% w/v) supplied as ready-to-use suspension in 20 mL, single-dose, bottle for oral administration. Each 20 mL bottle contains g of barium sulfate.. Oral suspension barium sulfate (40% w/v) 20 mL single dose bottles as ready to use suspension for oral administration (3). Oral suspension barium sulfate (40% w/v) 20 mL single dose bottles as ready to use suspension for oral administration (3).

GERIATRIC USE SECTION.

8.5 Geriatric Use. Clinical studies of TAGITOL do 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.

HOW SUPPLIED SECTION.

16 HOWSUPPLIED/STORAGE AND HANDLING. 16.1 How Supplied. TAGITOL (barium sulfate) is an oral suspension (40% w/v) supplied as box of three 20 mL bottles. Each bottle contains grams barium sulfate.Provided as: 24 boxes, each containing (20 mL) bottles (NDC 32909-814). 16.2 Storage and Handling. Store at room temperature 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Do Not Freeze.

INDICATIONS & USAGE SECTION.

1 INDICATIONSAND USAGE. TAGITOL is indicatedfor use in adult patients for use in computed tomography (CT) colonographyas fecal tagging agent.. TAGITOL is radiographic contrast agent indicated in adult patients for use in computed tomography (CT) colonography as fecal tagging agent (1).

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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment ofFertility. No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Due to its high atomic number, barium (the active ingredientin TAGITOL V) 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 pharmacological effects.. 12.3 Pharmacokinetics. Under physiological conditions, barium sulfate passes throughthe gastrointestinal tract in an unchanged form and is absorbed onlyin pharmacologically insignificant amounts.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. TAGITOL is contraindicated in patients with: known or suspected perforationof the gastrointestinal (GI) tract; known obstruction of the GI tract; high risk of GI perforationsuch as those with recent GI perforation, acute GI hemorrhage orischemia, toxic megacolon, severe ileus, post GI surgery or biopsy,acute GI injury or burn, or recent radiotherapy to the pelvis; high risk of aspirationsuch as those with prior aspiration, tracheo-esophageal fistula, orobtundation; knownhypersensitivity to barium sulfate or any of the excipients of TAGITOLV.. TAGITOL is contraindicated in patients with: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 TAGITOL (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 or aspiration (4). Known hypersensitivity to barium sulfate or any of the excipients of TAGITOL (4).

DESCRIPTION SECTION.

11 DESCRIPTION. TAGITOL (barium sulfate) is radiographic contrast agent that is supplied as 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with molecular weight of 233.4 g/mol and the following chemical structure:TAGITOL contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol.. barium-sulfate-structure.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. The recommended dose is:One 20 mL bottle (8g barium sulfate) with each meal (breakfast,lunch and dinner) the day before the CT colonographyexamination (2.1).Total dose 3 bottles (24 barium sulfate) For oral use only (2.2).. The recommended dose is:One 20 mL bottle (8g barium sulfate) with each meal (breakfast,lunch and dinner) the day before the CT colonographyexamination (2.1).Total dose 3 bottles (24 barium sulfate) One 20 mL bottle (8g barium sulfate) with each meal (breakfast,lunch and dinner) the day before the CT colonographyexamination (2.1).. Total dose 3 bottles (24 barium sulfate). For oral use only (2.2).. 2.1 Recommended Dosing. The recommended oral dose of TAGITOL is one 20 mL bottle (8 barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose 3 bottles (24 barium sulfate).. The recommended oral dose of TAGITOL is one 20 mL bottle (8 barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose 3 bottles (24 barium sulfate).. 2.2 Important Administration Instructions. TAGITOL is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient.Shake bottle for 15 seconds prior to administration.For oral use only.Encourage patients to hydrate following the barium sulfate procedure.Discard any unused suspension.. TAGITOL is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient.. Shake bottle for 15 seconds prior to administration.. For oral use only.. Encourage patients to hydrate following the barium sulfate procedure.. Discard any unused suspension.

INFORMATION FOR PATIENTS SECTION.

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)].Administration InstructionsTAGITOL is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient.Provide the patient with any site specific instructions regarding their procedure and when to take meals.Rx onlyManufactured byEZEM Canada IncAnjou (Quebec) Canada H1J 2Z4ForBracco Diagnostics Inc.Princeton, NJ 08540rev. 02/2025. 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)].

INSTRUCTIONS FOR USE SECTION.

INSTRUCTIONS FOR USETAGITOL (tag-i-tal ve)(barium sulfate)oral suspensionRead this Instructions for Use before you drink TAGITOL (barium sulfate) oral suspension. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.Important:Take TAGITOL exactly as your healthcare provider tells you. Your healthcare provider will prescribe the dose that is right for you. You can ask your healthcare provider or pharmacist if you have any questions about how to take TAGITOL V.How should store TAGITOL VBefore using TAGITOL store at room temperature between 68F and 77F (20C and 25C).Do not freeze.Keep TAGITOL and all medicines out of the reach of children.Supplies you will need: box containing bottles of TAGITOL V. Each bottle contains 20 mL of TAGITOL VHow should take TAGITOL VThe day before your procedure you will drink bottle of TAGITOL with each meal:Breakfast: Shake bottle of TAGITOL for 15 seconds, open the bottle, and drink the liquid with breakfast.Lunch: Shake bottle of TAGITOL for 15 seconds, open the bottle, and drink the liquid with lunch.Dinner: Shake bottle of TAGITOL for 15 seconds, open the bottle, and drink the liquid with dinner.Throw away any unused TAGITOL with normal household trash. Do not throw away by flushing down the drain.What should do if the TAGITOL spillsIf you spill the liquid while shaking or drinking it, you can clean it up. TAGITOL is not harmful and can be thrown away with normal household trash.If you spilled any of the liquid, check with your healthcare provider to find out if you need to change the date of the appointment for your procedure.This Instructions for Use has been approved by the U.S. Food and Drug AdministrationApproved: August 2017CL1598-01. Before using TAGITOL store at room temperature between 68F and 77F (20C and 25C).. Do not freeze.. box containing bottles of TAGITOL V. Each bottle contains 20 mL of TAGITOL V. Breakfast: Shake bottle of TAGITOL for 15 seconds, open the bottle, and drink the liquid with breakfast.. Lunch: Shake bottle of TAGITOL for 15 seconds, open the bottle, and drink the liquid with lunch.. Dinner: Shake bottle of TAGITOL for 15 seconds, open the bottle, and drink the liquid with dinner.

LABOR & DELIVERY SECTION.

8.2 Lactation. Risk SummaryTAGITOL is not absorbed systemically bythe mother following oral administration and breastfeeding is notexpected to result in exposure of the infant to the drug [seeClinical Pharmacology (12.3)].

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Due to its high atomic number, barium (the active ingredientin TAGITOL V) 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 ofFertility. No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Tagitol Internal LabelNDC: 32909-814-55. Tagitol Internal Label.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. TAGITOL is not indicated for pediatric use.

PHARMACODYNAMICS SECTION.

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

PHARMACOKINETICS SECTION.

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

PREGNANCY SECTION.

8.1 Pregnancy. Risk SummaryTAGITOL 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)].

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosing. The recommended oral dose of TAGITOL is one 20 mL bottle (8 barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose 3 bottles (24 barium sulfate).. The recommended oral dose of TAGITOL is one 20 mL bottle (8 barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose 3 bottles (24 barium sulfate).

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryTAGITOL 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 SummaryTAGITOL is not absorbed systemically bythe mother following oral administration and breastfeeding is notexpected to result in exposure of the infant to the drug [seeClinical Pharmacology (12.3)] 8.4 Pediatric Use. TAGITOL is not indicated for pediatric use.. 8.5 Geriatric Use. Clinical studies of TAGITOL do 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.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal barium leakage: May occur in conditionswhich increase the risk of perforation such as carcinoma, GI fistula,inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,diverticulitis, or severe stenosis or obstructing lesions of the GItract (5.2)Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction by baroliths (5.3)Aspiration pneumonitis: Caution is recommended in patientswith history of food aspiration and in patients with known swallowingdisorders (5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal barium leakage: May occur in conditionswhich increase the risk of perforation such as carcinoma, GI fistula,inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,diverticulitis, or severe stenosis or obstructing lesions of the GItract (5.2). Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction by baroliths (5.3). Aspiration pneumonitis: Caution is recommended in patientswith history of food aspiration and in patients with known swallowingdisorders (5.4). 5.1 Hypersensitivity Reactions. Barium sulfate preparations contain number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria and itching. history of bronchial asthma, atopy, or previous reaction to contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of hypersensitivity reaction.. 5.2 Intra-abdominal Barium Leakage. The use of TAGITOL is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of TAGITOL may result in leakage of barium from the GI tract in the presence of conditions that increase the risk of perforation such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with severe stenosis at any level of the gastrointestinal tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.. 5.3 Delayed Gastrointestinal Transit and Obstruction. Orally administered barium sulfatemay accumulate proximal to constricting lesion of the colon, causingobstruction or impaction with development of baroliths (inspissatedbarium associated with feces) and may lead to abdominal pain, appendicitis,bowel obstruction, or rarely perforation. Patients with the followingconditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired gastrointestinalmotility, electrolyte imbalance, dehydration, on low residue diet,on medications that delay GI motility, constipation, cystic fibrosis,Hirschsprung disease, and the elderly. To reduce the risk of delayedGI transit and obstruction, patients should maintain adequate hydrationfollowing barium sulfate procedure.. 5.4 Aspiration Pneumonitis. The use of TAGITOL is contraindicated in patients at high risk of aspiration [see Contraindications (4)]. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis.. 5.5 Systemic Embolization. Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel 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 products, monitor patients for potential intravasation when administering barium sulfate.