Varibar Thin Honey
(Barium Sulfate)Varibar Thin Honey Prescribing Information
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.
- For oral use only – administer by syringe, spoon, or cup.
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.
VARIBAR THIN HONEY is contraindicated
in patients with:
- known or suspected perforation of the gastrointestinal (GI)
tract - known obstruction of the GI tract
- high risk of GI perforation such as those with a recent
GI perforation, acute GI hemorrhage or ischemia, toxic megacolon,
severe ileus, post GI surgery or biopsy, acute GI injury or burn,
or recent radiotherapy to the pelvis - high risk of aspiration such as those with known or suspected
tracheo-esophageal fistula or obtundation - known severe hypersensitivity to barium sulfate or any of
the excipients of VARIBAR THIN HONEY
- Hypersensitivity reactions: Emergency equipment and trained
personnel should be immediately available ()5.1 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, 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 LeakageThe use of VARIBAR THIN HONEY is contraindicated
in patients at high risk of perforation of the GI tract[see. Administration
Contraindications ]
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 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[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 PneumonitisThe 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.