NDC 32909-116 Varibar Nectar

Barium Sulfate

NDC Product Code 32909-116

NDC 32909-116-00

Package Description: 240 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Varibar Nectar with NDC 32909-116 is a a human prescription drug product labeled by E-z-em Canada Inc. The generic name of Varibar Nectar is barium sulfate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: E-z-em Canada Inc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Varibar Nectar Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BARIUM SULFATE 400 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Radiographic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • X-Ray Contrast Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: E-z-em Canada Inc
Labeler Code: 32909
FDA Application Number: NDA208143 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Varibar Nectar Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1  Indications And Usage

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

  • The recommended dose of VARIBAR NECTAR administered orally
  • By syringe, spoon, or cup:Adults                                                                                    5
  • MLPediatric patients 6 months and older                         1-3
  • MLPediatric patients younger than 6 months of age    0.5-1
  • ML(This amount may be administered by an oral syringe
  • Or, alternatively, an infant bottle)During a single modified barium swallow examination, multiple
  • Doses of VARIBAR NECTAR may be administered as appropriate 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.Encourage patients to hydrate following the
barium sulfate procedure.

3  Dosage Forms And Strengths

Oral suspension: barium sulfate
(40% w/v) supplied in a multiple dose HDPE plastic bottle as a suspension
for oral administration. Each bottle contains 240 mL of suspension.

4  Contraindications

  • VARIBAR NECTAR is contraindicated in patients
  • With: known or suspected perforation of the GI tractknown obstruction of the GI tracthigh risk of GI perforation such as those with a recent
  • Prior 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 pelvishigh risk for aspiration such as those with known or suspected
  • Tracheo-esophageal fistula or obtundationknown severe hypersensitivity to barium sulfate or any of
  • The excipients of VARIBAR NECTAR

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, dermal reactions including rashes,
urticaria and itching. A history of bronchial asthma, atopy 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 NECTAR is contraindicated in patients at high
risk of perforation of the GI tract [see Contraindications
(4)]. Administration of VARIBAR
NECTAR may result in leakage of barium at any level of 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 following a barium sulfate procedure.

5.4 Aspiration Pneumonitis

The use of VARIBAR NECTAR is contraindicated in patients with tracheo-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 NECTAR.
Aspiration of small volumes of barium sulfate may occur during the
modified barium swallow procedure in some patients. Monitor the patient
closely for aspiration, discontinue administration 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 large bowel 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 barium sulfate
products, 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:Nausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspiration
  • Pneumonitis, barium sulfate impaction, intestinal perforation with
  • Consequent peritonitis and granuloma formation, vasovagal and syncopal
  • Episodes

8.1 Pregnancy

Risk SummaryVARIBAR NECTAR is not absorbed systemically
following oral administration, and maternal use is not expected to
result in fetal exposure to the drug [see Clinical Pharmacology
(12.3)].

8.2 Lactation

Risk SummaryVARIBAR NECTAR is not absorbed systemically
by the mother following oral administration, and breastfeeding is
not expected to result in exposure of the infant to VARIBAR NECTAR [see Clinical Pharmacology (12.3)].

8.4 Pediatric Use

The efficacy
of VARIBAR NECTAR in pediatric patients from birth to less than 17
years of age is based on successful opacification of the oropharynx
during modified barium swallow examinations [see Clinical
Pharmacology (12.1)]. Safety
and dosing recommendations in pediatric patients are based on clinical
experience [see Dosage and Administration (2.1)].VARIBAR NECTAR is contraindicated in pediatric
patients with tracheo-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)]. Patients
with cystic fibrosis or Hirschsprung disease should be monitored for
small bowel obstruction after use [see Warnings and Precautions
(5.3)]

8.5 Geriatric Use

Clinical
studies of VARIBAR NECTAR do 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 NECTAR (barium sulfate) is a radiographic contrast agent
for oral administration that is supplied as a 40% w/v, smooth, off-
white to lightly colored free-flowing suspension with an apple aroma.
The active ingredient is designated chemically as BaSO4 which has a density of 4.5 g/cm3, a molecular weight of 233.4 g/mol, and the following chemical structure:VARIBAR NECTAR has a viscosity
of 300 cPs and contains the following excipients: carboxymethylcellulose
sodium, citric acid, glycerin, maltodextrin, natural and artificial
apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin
sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan
gum, and xylitol.

12.1 Mechanism Of Action

Due to its high atomic number, barium (the active ingredient in VARIBAR
NECTAR) 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 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  How Supplied/Storage And Handling

How SuppliedVARIBAR NECTAR is supplied in
a multiple-dose HDPE bottle containing 240 mL of barium sulfate (40%
w/v).Provided as:
12 x 240 mL bottles (NDC 32909-115-00)Storage and HandlingStore at USP controlled
room temperature 20 to 25°C (68 to 77° F). Protect from freezing.Once opened, VARIBAR NECTAR
may be used for up to 21 days when stored at USP controlled room temperature,
20 to 25°C (68 to 77° F).

17  Patient Counseling Information

  • After administration, advise patients to:Maintain adequate hydration [see Dosage and Administration
  • (2.2) and Warnings and Precautions
  • (5.3)].Seek medical attention for worsening of constipation or
  • Slow gastrointestinal passage [see Warnings and Precautions
  • (5.3)].Seek medical attention for any delayed onset of hypersensitivity:
  • Rash, urticaria, or respiratory difficulty [see Warnings and
  • Precautions (5.1)].Rx onlyManufactured forBracco
  • Diagnostics Inc.Monroe Township, NJ 08831by
  • EZEM Canada IncAnjou (Quebec) Canada H1J 2Z4

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