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 VARIBAR NECTAR is contraindicated in patients at high risk of perforation of the GI tract [see CONTRAINDICATIONS]. Administration of VARIBAR NECTAR may result in leakage of barium at any level of the GI tract in the presence of conditions 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 GI 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 GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly [see Use In Specific Populations]. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure.
The use of VARIBAR NECTAR is contraindicated in patients with tracheo-esophageal fistula [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.
In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR NECTAR. Aspiration of small volumes of barium sulfate may occur during the modified barium swallow procedure in some patients. Monitor the patient closely for aspiration, discontinue administration if aspiration is suspected and monitor for development of 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.
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
VARIBAR NECTAR is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see CLINICAL PHARMACOLOGY].
VARIBAR NECTAR is not absorbed systemically by the mother following oral administration, and breastfeeding is
not expected to result in exposure of the infant to VARIBAR NECTAR [see CLINICAL PHARMACOLOGY].
The efficacy of VARIBAR NECTAR in pediatric patients from birth to less than 17 years of age is based on
successful opacification of the oropharynx during modified barium swallow examinations [see CLINICAL PHARMACOLOGY]. Safety and dosing recommendations in pediatric patients are based on clinical experience
[see DOSAGE AND ADMINISTRATION].
VARIBAR NECTAR is contraindicated in pediatric patients with tracheo-esophageal fistula [see CONTRAINDICATIONS]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of
hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]. Patients with cystic fibrosis or Hirschsprung
disease should be monitored for small bowel obstruction after use [see WARNINGS AND PRECAUTIONS]
Clinical studies of VARIBAR NECTAR 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.