Varibar Honey

Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available (5.1) Intra-abdominal leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract (5.2) Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction (5.3) Aspiration Pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration (5.4)

5.1Hypersensitivity Reactions

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. 5.2 Intra-abdominal Barium Leakage The use of VARIBAR HONEY is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of VARIBAR HONEY 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. 5.3 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 (8.4, 8.5)]. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure. 5.4 Aspiration Pneumonitis The use of VARIBAR HONEY 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 HONEY. Monitor the patient closely for aspiration, discontinue administration of VARIBAR HONEY if aspiration is suspected, and monitor for development of aspiration pneumonitis. 5.5 Systemic Embolization 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.

8.1Pregnancy Risk Summary

VARIBAR HONEY is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary VARIBAR HONEY 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. 8.4 Pediatric Use The efficacy of VARIBAR HONEY in pediatric patients above 6 months of age 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 above 6 months of age are based on clinical experience. VARIBAR HONEY 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)]. 8.5 Geriatric Use Clinical studies of VARIBAR HONEY 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.