No Information Provided
TAGITOL V 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 prior aspiration, tracheo-esophageal fistula, or obtundation;
known hypersensitivity to barium sulfate or any of the excipients of TAGITOL V.
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:
TAGITOL V is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent.
Barium sulfate is biologically inert and has no known pharmacological effects.
TAGITOLVis not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.
Oral suspension: barium sulfate (40% w/v) supplied as a ready-to-use suspension in a 20 mL, singledose, plastic bottle for oral administration. Each 20 mL bottle contains 8 g of barium sulfate.
TAGITOL V (barium sulfate) is an oral suspension (40% w/v) supplied as a box of three 20 mL HDPE bottles. Each bottle contains 8 grams barium sulfate.
Provided as: 24 boxes, each containing 3 (20 mL) bottles (NDC 32909-814)
Storage And HandlingStore at USP controlled room temperature 20 to 25°C (68 to 77° F). Protect from freezing.
Manufactured by: EZEM Canada Inc, Anjou (Quebec) Canada H1J 2Z4. Revised: Aug 2017
Included as part of the "PRECAUTIONS" Section
PRECAUTIONS Hypersensitivity ReactionsBarium sulfate preparations contain a 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. A history of bronchial asthma, atopy, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.
Intra-Abdominal Barium LeakageThe use of TAGITOL V is contraindicated in patients at high risk of perforation of the GI tract. Administration of TAGITOL V 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 a 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.
Delayed Gastrointestinal Transit And ObstructionOrally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired gastrointestinal motility, electrolyte imbalance, dehydration, on a low residue diet, on medications that delay GI motility, constipation, cystic fibrosis, Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure.
Aspiration PneumonitisThe use of TAGITOL V is contraindicated in patients at high risk of aspiration. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis.
Systemic EmbolizationBarium sulfate products may occasionally intravasate into the venous drainage of the large bowel and enter the circulation as a "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.
Patient Counseling InformationAfter administration, advise patients to:
TAGITOL V 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.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of FertilityNo animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.
Use In Specific Populations Pregnancy Risk SummaryTAGITOLVis not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.
Lactation Risk SummaryTAGITOL V 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
Pediatric UseTAGITOL V is not indicated for pediatric use.
Geriatric UseClinical studies of TAGITOL V 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.
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:
No Information Provided
