Drugplain

Varibar Honey 400 mg/mL

barium sulfate · SUSPENSION · E-Z-EM Canada Inc

No Recall History
Plain English

Varibar Honey is a suspension containing barium sulfate at 400 mg/mL, taken oral. Manufactured by E-Z-EM Canada Inc.

Key Facts

Brand Name
Varibar Honey
Generic Name
barium sulfate
NDC Code (Product)
32909-122
Manufacturer
E-Z-EM Canada Inc
Strength
400 mg/mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
NDA208143
Drug Class
Radiographic Contrast Agent [EPC]
Marketing Start
03/01/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

renal failure18 reports
acute kidney injury17 reports
urticaria16 reports
chronic kidney disease15 reports
diarrhoea14 reports
rash14 reports
dyspnoea13 reports
drug hypersensitivity12 reports
pruritus12 reports
vomiting12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VARIBAR HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR HONEY is a radiopaque contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral use only – administer by syringe or spoon. 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 ) 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 Important Administration Instructions For oral use only Advise patients to hydrate following the barium sulfate procedure.

Contraindications

4 CONTRAINDICATIONS VARIBAR 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 HONEY Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR HONEY ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Frequently Asked Questions

What is Varibar Honey used for?

Varibar Honey contains barium sulfate. It is a suspension taken oral. Consult your doctor for specific uses.

Is Varibar Honey a controlled substance?

Varibar Honey is not classified as a controlled substance by the DEA.

What is the generic name for Varibar Honey?

The generic name for Varibar Honey is barium sulfate. There are 11 other brand versions of barium sulfate.

What is the NDC code for Varibar Honey 400 mg/mL?

The NDC (National Drug Code) for Varibar Honey 400 mg/mL is 32909-122, listed by E-Z-EM Canada Inc.

Product NDC

32909-122

Package NDC

32909-122-07

Other Barium Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)