VARIBAR THIN LIQUID- barium sulfate powder, for suspension 
E-Z-EM Canada Inc

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use
VARIBAR THIN LIQUID safely and effectively.
See full prescribing information for VARIBAR THIN LIQUID.

VARIBAR THIN LIQUID (barium sulfate) for oral suspension

Initial U.S. Approval: 2016

INDICATIONS AND USAGE

VARIBAR THIN LIQUID 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 (1)

DOSAGE AND ADMINISTRATION

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)
  • Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions (2.2)

DOSAGE FORMS AND STRENGTHS

For oral suspension: 120 g barium sulfate (81% w/w) supplied in a multiple-dose bottle for reconstitution (3)

CONTRAINDICATIONS

  • 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 THIN LIQUID (4)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available (5.1)
  • 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)
  • Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction (5.3)
  • Aspiration pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration (5.4)

ADVERSE REACTIONS

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

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing and Administration Instructions

2.2 Instructions for Reconstitution

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 Intra-abdominal Barium Leakage

5.3 Delayed Gastrointestinal Transit and Obstruction

5.4 Aspiration Pneumonitis

5.5 Systemic Embolization

6 ADVERSE REACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients.

2 DOSAGE AND ADMINISTRATION

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.

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.

3 DOSAGE FORMS AND STRENGTHS

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.

4 CONTRAINDICATIONS

VARIBAR THIN LIQUID is contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

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 THIN LIQUID is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. 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.

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 THIN LIQUID 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 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.

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.

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:

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

VARIBAR THIN LIQUID 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 THIN LIQUID 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 THIN LIQUID in pediatric patients 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 are based on clinical experience.

VARIBAR THIN LIQUID 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 THIN LIQUID 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.

11 DESCRIPTION

VARIBAR THIN LIQUID (barium sulfate) is a radiographic contrast agent that is supplied as a white to lightly colored powder for suspension (81% w/w) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure:

Barium Sulfate Chemical Structure

VARIBAR THIN LIQUID has a viscosity of <15 cPs when reconstituted and contains the following excipients: carboxymethylcellulose sodium, citric acid, maltodextrin, natural and artificial apple flavor, polysorbate 80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in VARIBAR THIN LIQUID) 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 NONCLINICAL TOXICOLOGY

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 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

VARIBAR THIN LIQUID is supplied as a white to lightly colored powder in a multiple-dose polyethylene bottle containing 120 grams of barium sulfate (81% w/w).

Provided as: 24 x 148 g bottles (NDC 32909-105-10)

16.2 Storage and Handling

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

17 PATIENT COUNSELING INFORMATION

After administration, advise patients to:


Rx Only

Manufactured by
EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4

For
Bracco Diagnostics Inc.
Monroe Township, NJ 08831

VARIBAR is a registered trademark of E-Z-EM, Inc.

Varibar® Thin Liquid - Barium Sulfate for Suspension
NDC: 32909-105-10

Varibar Thin Liquid - Internal
Varibar Thin Liquid - External
VARIBAR THIN LIQUID 
barium sulfate powder, for suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:32909-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E) Barium Sulfate.81 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
carboxymethylcellulose sodium (UNII: K679OBS311)  
dimethicone 1000 (UNII: MCU2324216)  
maltodextrin (UNII: 7CVR7L4A2D)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sorbitol (UNII: 506T60A25R)  
trisodium citrate dihydrate (UNII: B22547B95K)  
xylitol (UNII: VCQ006KQ1E)  
saccharin sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:32909-105-1024 in 1 CASE04/30/2019
1148 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20803604/30/2019
Labeler - E-Z-EM Canada Inc (204211163)
Registrant - E-Z-EM, INC. (002041226)
Establishment
NameAddressID/FEIBusiness Operations
E-Z-EM Canada Inc204211163PACK(32909-105) , LABEL(32909-105) , MANUFACTURE(32909-105) , ANALYSIS(32909-105)

Revised: 4/2019
Document Id: f4146844-0e44-7283-5e94-6c463f0cb766
Set id: 59493c83-3941-cc84-cc37-a8696ae42873
Version: 5
Effective Time: 20190430
 
E-Z-EM Canada Inc