Varibar Thin Honey

VARIBAR THIN HONEY is indicated
for modified barium swallow examinations to evaluate the oral and
pharyngeal function and morphology in adult and pediatric patients.

• For oral use only – administer by syringe, spoon, or cup.
  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, spoon, or cup.
    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 THIN HONEY administered
    orally by syringe, spoon, or cup is:
    • Adults: 5 mL
    • Pediatric patients: 1 to 3 mL
  • During a single modified barium swallow examination, multiple
    doses of VARIBAR THIN 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 Important Administration Instructions

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

Oral suspension: barium sulfate
(40% w/v) supplied in either 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 THIN 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 (
  5.1 Hypersensitivity 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.
  )
• 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 THIN HONEY is contraindicated
  in patients at high risk of perforation of the GI tract

  [see
  Contraindications ]

  . Administration
  of VARIBAR THIN 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 THIN 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 THIN HONEY.
  Monitor the patient closely for aspiration, discontinue administration
  of VARIBAR THIN HONEY if aspiration is suspected, and monitor for
  development of aspiration pneumonitis.
  )