Varibar Honey - Barium Sulfate suspension

VARIBAR HONEY is indicated for modified barium swallow examinations
to evaluate the oral and pharyngeal function and morphology in adult
and pediatric patients 6 months of age and older.

For oral use only – administer
by syringe or spoon. The recommended dose is:

• Adults: 5 mL
• Pediatric patients: 1 to 3 mL
• During a single modified barium swallow examination, multiple
  doses may be administered
• Maximum cumulative dose: 30 mL (
  2  Dosage
  and administration

  For oral use only – administer
  by syringe or spoon. The recommended dose is:

  • Adults: 5 mL
  • Pediatric patients: 1 to 3 mL
  • During a single modified barium swallow examination, multiple
    doses may be administered
  • Maximum cumulative dose: 30 mL

  2.1 Recommended Dosing

  • The recommended dose of VARIBAR HONEY administered orally
    by syringe, spoon, or cup is:
    • Adults: 5 mL
    • Pediatric patients 6 months of age and older: 1 to 3 mL
  • During a single modified barium swallow examination, multiple
    doses of VARIBAR HONEY may be administered, to assess the patient
    during multiple swallows and different radiographic views.
  • The maximum cumulative dose is 30 mL.
  • Once opened, write the discard after date on the immediate
    container label. Discard any unused product after 21 days.

  2.2 Administration
  Instructions

  • For oral use only
  • Advise patients to hydrate following the barium sulfate
    procedure.
  )

Oral suspension: barium sulfate
(40% w/v) supplied in a multiple-dose plastic bottle or tube as a
ready-to-use suspension for oral administration. Each bottle contains
250 mL of suspension; each tube contains 30 mL of suspension.

VARIBAR HONEY is not
absorbed systemically following oral administration, and maternal
use is not expected to result in fetal exposure to the drug.

Hypersensitivity reactions: Emergency
equipment and trained personnel should be immediately available (

• 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 Intra-abdominal
  Barium Leakage

  The use of VARIBAR HONEY is contraindicated in patients at high risk
  of perforation of the GI tract

  [see Contraindications ]

  . 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.
  )
• Delayed GI transit and obstruction: Patients should maintain
  adequate hydration in days following barium sulfate procedure to avoid
  obstruction or impaction (
  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 ]

  . To reduce the risk of delayed
  GI transit and obstruction, patients should maintain adequate hydration
  after the barium sulfate procedure.
  )
• Aspiration pneumonitis: Aspiration may occur during the
  modified barium swallow examination, monitor the patient for aspiration
  (
  5.4 Aspiration
  Pneumonitis

  The
  use of VARIBAR HONEY is contraindicated in patients with trachea-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 HONEY.
  Monitor the patient closely for aspiration, discontinue administration
  of VARIBAR HONEY if aspiration is suspected, and monitor for development
  of aspiration pneumonitis.
  )