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.

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.

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 (4)]. 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.

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 (8.4, 8.5)]. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure.

5.4 Aspiration Pneumonitis

The use of VARIBAR HONEY is contraindicated in patients with trachea-esophageal fistula [see Contraindications (4)]. 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.

5.5 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.

8.1 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.

8.2 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.

8.4 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 (12.1)]. 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 (4)]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5. 1)]. Monitor patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use [see Warnings and Precautions (5.3)].

8.5 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.

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in VARIBAR HONEY) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2 Pharmacodynamics

Barium sulfate is biologically inert and has no known pharmacological effects.

12.3 Pharmacokinetics

Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

16.1 How Supplied

VARIBAR HONEY is supplied as a suspension in both a multiple-dose polyethylene bottle containing 250 mL and multiple-dose polyethylene tube containing 30 mL of barium sulfate (40 % w/v).

Provided as: 12 x 250 mL bottles (NDC 32909-122-07); 24 x 30 mL tubes (NDC 32909-122-54)

16.2 Storage and Handling

Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from freezing.

Once opened, VARIBAR HONEY may be used for up to 21 days when stored at USP controlled room temperature, 20°C to 25°C (68°F to 77°F).