Included as part of the "PRECAUTIONS" Section
Barium 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 Leakage
The use of TAGITOL V is contraindicated in patients at high risk of perforation of the GI tract [see CONTRAINDICATIONS]. 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 Obstruction
Orally 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.
The use of TAGITOL V is contraindicated in patients at high risk of aspiration [see CONTRAINDICATIONS]. 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.
Barium 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 Information
After administration, advise patients to:
- Maintain adequate hydration [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
- Seek medical attention for worsening of constipation or slow gastrointestinal passage [see WARNINGS AND PRECAUTIONS].
- Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory
difficulty [see WARNINGS AND PRECAUTIONS].
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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or
potential effects on fertility.
Use In Specific Populations
TAGITOLVis not absorbed systemically following oral administration, and maternal use is not expected
to result in fetal exposure to the drug [see CLINICAL PHARMACOLOGY].
TAGITOL 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 [see CLINICAL PHARMACOLOGY]
TAGITOL V is not indicated for pediatric use.
Clinical 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.