WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
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 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 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
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.
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.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis,
Impairment Of Fertility
No animal studies have been
performed to evaluate the carcinogenic potential of barium sulfate or potential
effects on fertility.
Use In Specific Populations
Pregnancy
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.
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.
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]. 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]. Pediatric
patients with a history of asthma or food allergies may be at increased risk
for development of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Monitor patients with cystic fibrosis or Hirschsprung disease for bowel
obstruction after use [see WARNINGS AND PRECAUTIONS].
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.