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VARIBAR NECTAR is contraindicated in patients with:
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:
VARIBAR NECTAR is indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients.
Barium sulfate is biologically inert and has no known pharmacological effects.
VARIBAR NECTAR is 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 in a multiple dose HDPE plastic bottle as a suspension for oral administration. Each bottle contains 240 mL of suspension.
Storage And HandlingVARIBAR NECTAR is supplied in a multiple-dose HDPE bottle containing 240 mL of barium sulfate (40% w/v).
Provided as: 12 x 240 mL bottles (NDC 32909-115-00)
Storage And HandlingStore at USP controlled room temperature 20 to 25°C (68 to 77° F). Protect from freezing.
Once opened, VARIBAR NECTAR may be used for up to 21 days when stored at USP controlled room temperature, 20 to 25°C (68 to 77° F).
Manufactured by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4. Revised: July 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 VARIBAR NECTAR is contraindicated in patients at high risk of perforation of the GI tract. 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 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 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. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure.
Aspiration PneumonitisThe use of VARIBAR NECTAR is contraindicated in patients with tracheo-esophageal fistula. 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.
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.
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 SummaryVARIBAR NECTAR is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.
Lactation Risk SummaryVARIBAR 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.
Pediatric UseThe 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. Safety and dosing recommendations in pediatric patients are based on clinical experience .
VARIBAR NECTAR is contraindicated in pediatric patients with tracheo-esophageal fistula. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Patients with cystic fibrosis or Hirschsprung disease should be monitored for small bowel obstruction after use
Geriatric UseClinical 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.
For oral use only.
Encourage patients to hydrate following the barium sulfate procedure.
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:
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