Varibar Thin Liquid

VARIBAR
THIN LIQUID 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– once reconstituted,
administer by infant bottle, syringe, spoon, or cup. The recommended
dose is:

  ● Adults: 5 mL

  ● Pediatric patients 6 months and older: 1 mL to 3 mL

  ● Pediatric patients younger than 6 months of age: 0.5 mL to
1 mL

• During a single modified barium swallow examination, multiple
  doses may be administered
• Maximum cumulative dose: 80 mL (
  2.1 Recommended Dosing
  and Administration Instructions

  • The recommended dose of reconstituted VARIBAR THIN LIQUID
    administered orally by infant bottle, syringe, spoon, or cup is:
    • Adults: 5 mL
    • Pediatric patients 6 months and older: 1 mL to 3 mL
    • Pediatric patients younger than 6 months of age: 0.5 mL
      to 1 mL
  • During a single modified barium swallow examination, multiple
    doses of VARIBAR THIN LIQUID may be administered, to assess the patient
    during multiple swallows and different radiographic views.
  • The maximum cumulative dose is 80 mL.
  • For oral use only
  • Advise patients to hydrate following the barium sulfate
    procedure.
  )
• Must reconstitute supplied powder with water prior to use.
  See Full Prescribing Information for reconstitution instructions (
  2.2 Instructions for
  Reconstitution

  The VARIBAR THIN LIQUID powder must be reconstituted prior to administration
  by a healthcare provider according to the following instructions:

  • Add water to the fill line on the bottle label
  • Replace the lid securely
  • Invert the bottle and tap with fingers to mix the powder
    into the water
  • Shake vigorously for 30 seconds. Let stand for 5 minutes
  • Refill with water to the fill line on the bottle label and
    reshake thoroughly.
  • Once reconstituted, write the discard after date on the
    immediate container label. After reconstitution, store in refrigerator
    at 2°C to 8°C (36ºF to 46ºF) for up to 72 hours.
  • Reconstitution yields approximately 300 mL of VARIBAR THIN
    LIQUID oral suspension containing 0.4 grams of barium sulfate per
    mL (40% w/v) and should be homogeneous and white to lightly colored.
  )

For oral suspension: 120 grams
of barium sulfate supplied as a white to lightly colored powder (81%
w/w) in a multiple-dose plastic bottle for reconstitution.

VARIBAR THIN LIQUID
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 LIQUID is contraindicated in patients at
  high risk of perforation of the GI tract

  [see Contraindications
  ]

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