VARIBAR THIN LIQUID- barium sulfate powder, for suspension
E-Z-EM Canada Inc
HIGHLIGHTS OF PRESCRIBING INFORMATION
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VARIBAR THIN LIQUID safely and effectively.
See full prescribing information for VARIBAR THIN LIQUID.
VARIBAR THIN LIQUID (barium sulfate) for oral suspension
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
VARIBAR THIN LIQUID is a radiopaque contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients (1)
DOSAGE AND ADMINISTRATION
For oral use only– once reconstituted, administer by infant bottle, syringe, spoon, or cup. The recommended dose is:
● Adults: 5 mL
DOSAGE FORMS AND STRENGTHS
For oral suspension: 120 g barium sulfate (81% w/w) supplied in a multiple-dose bottle for reconstitution (3)
WARNINGS AND PRECAUTIONS
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
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, and dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, food allergies, 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.
The use of VARIBAR THIN LIQUID is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of VARIBAR THIN LIQUID may result in leakage of barium from 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.
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 (8.4, 8.5)]. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure.
The use of VARIBAR THIN LIQUID is contraindicated in patients with trachea-esophageal fistula [see Contraindications (4)]. 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 THIN LIQUID. Monitor the patient closely for aspiration, discontinue administration of VARIBAR THIN LIQUID if aspiration is suspected, and monitor for development of aspiration pneumonitis.
Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract 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 a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.
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:
The efficacy of VARIBAR THIN LIQUID in pediatric patients is based on successful opacification of the pharynx during modified barium swallow examinations [see Clinical Pharmacology (12.1)]. Safety and dosing recommendations in pediatric patients are based on clinical experience.
VARIBAR THIN LIQUID is contraindicated in pediatric patients with trachea-esophageal fistula. [see Contraindications (4)]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Monitor patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use [see Warnings and Precautions (5.3)].
Clinical studies of VARIBAR THIN LIQUID did 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.
VARIBAR THIN LIQUID (barium sulfate) is a radiographic contrast agent that is supplied as a white to lightly colored powder for suspension (81% w/w) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure:
VARIBAR THIN LIQUID has a viscosity of <15 cPs when reconstituted and contains the following excipients: carboxymethylcellulose sodium, citric acid, maltodextrin, natural and artificial apple flavor, polysorbate 80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol.
|VARIBAR THIN LIQUID
barium sulfate powder, for suspension
|Labeler - E-Z-EM Canada Inc (204211163)|
|Registrant - E-Z-EM, INC. (002041226)|
|E-Z-EM Canada Inc||204211163||PACK(32909-105) , LABEL(32909-105) , MANUFACTURE(32909-105) , ANALYSIS(32909-105)|