NDC 32909-926 Neulumex

Barium Sulfate

NDC Product Code 32909-926

NDC 32909-926-03

Package Description: 450 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Neulumex with NDC 32909-926 is a a human prescription drug product labeled by E-z-em Canada Inc. The generic name of Neulumex 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.

Neulumex 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 1 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DIMETHICONE 350 (UNII: 2Y53S6ATLU)
  • DIMETHICONE 1000 (UNII: MCU2324216)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-01-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Neulumex 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

Description:

NeuLumEX is a barium sulfate suspension 0.1% w/v,
0.1% w/w for oral administration. Each 100 mL contains 0.1 g barium
sulfate. Barium sulfate, due to its high molecular density is opaque
to x-rays and therefore, acts as a positive contrast agent for radiographic
studies. The active ingredient is barium sulfate and its structural
formula is BaSO4. Barium sulfate occurs as
a fine, white, odorless, tasteless, bulky powder which is free from
grittiness. Its aqueous suspensions are neutral to litmus. It is practically
insoluble in water, solutions of acids and alkalies, and organic solvents. Inactive Ingredients: citric acid, natural gum, benzoic acid,
sodium citrate, natural and artificial blueberry flavor, potassium
sorbate, purified water, saccharin sodium, simethicone emulsion, sodium
benzoate, and sorbitol.

Clinical Pharmacology:

Barium sulfate, due to its high
molecular density is opaque to x-rays and, therefore, acts as a positive
contrast agent for radiographic studies. Barium sulfate is biologically
inert and, therefore, is not absorbed or metabolized by the body,
and is eliminated from the GI tract unchanged.

Indications And Usage:

For use in Computed Tomography to opacify the GI tract.

Contraindications:

This product should not be used in patients with
known or suspected gastrointestinal perforation or hypersensitivity
to barium sulfate or any component of this barium sulfate formulation.

Warnings:

Rarely, severe allergic reactions of an anaphylactoid
nature, have been reported following administration of barium sulfate
contrast agents. Appropriately trained personnel and facilities should
be available for emergency treatment of severe reactions and should
remain available for at least 30 to 60 minutes following administration,
since delayed reactions can occur.

General:

Diagnostic procedures which involve the use of
radiopaque contrast agents should be carried out under the direction
of personnel with the requisite training and with a thorough knowledge
of the particular procedure to be performed. A history of bronchial
asthma, atopy, as evidenced by hay fever and eczema, or a previous
reaction to a contrast agent, warrant special attention. Caution should
be exercised with the use of radiopaque media in severely debilitated
patients and in those with marked hypertension or advanced cardiac
disease. Ingestion of barium is not recommended in patients with a
history of food aspiration. If barium studies are required in these
patients or in patients in whom integrity of the swallowing mechanism
is unknown, proceed with caution. If barium is aspirated into the
larynx, further administration should be immediately discontinued.

Information For Patients:

  • Before administration
  • Of this product, patients receiving barium sulfate diagnostic agents
  • Should be instructed to:Inform their physician if they are pregnant.Inform their physician if they are allergic to any drugs
  • Or food, or if they have had any prior reactions to barium sulfate
  • Products or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).Inform their physician about any other medications they
  • Are currently taking.Seek immediate medical attention if they experience an allergic
  • Reaction after using this product.

Drug Interactions:

The presence of barium sulfate formulations in
the GI tract may alter the absorption of therapeutic agents taken
concomitantly. In order to minimize any potential change in absorption,
the separate administration of barium sulfate from that of other agents
should be considered.

Usage In Pregnancy:

Radiation is known to cause harm
to the unborn fetus exposed in utero. Therefore, radiographic procedures
should only be used when, in the judgement of the physician, its use
is deemed essential to the welfare of the pregnant patient.

Nursing Mothers:

Barium sulfate products may be used during
lactation.

Adverse Reactions:

Adverse reactions,
such as nausea, vomiting, diarrhea and abdominal cramping, accompanying
the use of barium sulfate formulations are infrequent and usually
mild. Severe reactions (approximately 1 in 1,000,000) and fatalities
(approximately 1 in 10,000,000) have occurred. Procedural complications
are rare, but may include aspiration pneumonitis, granuloma formation,
intravasation, embolization and peritonitis following intestinal perforation,
vasovagal and syncopal episodes, and fatalities.

Allergic Reactions:

Due to the increased likelihood
of allergic reactions in atopic patients, it is important that a complete
history of known and suspected allergies as well as allergic-like
symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria,
be obtained prior to any medical procedure utilizing these products.
A mild allergic reaction would most likely include generalized pruritus,
erythema or urticaria (approximately 1 in 250,000). Such reactions
will generally respond to an antihistamine such as 50 mg of diphenhydramine
or its equivalent. In the rarer, more serious reactions (approximately
1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could
develop. Severe reactions which may require emergency measures are
often characterized by peripheral vasodilation, hypotension, reflex
tachycardia, dyspnea, agitation, confusion and cyanosis, progressing
to unconsciousness. Treatment should be initiated immediately with
0.3 to 0.5 cc of 1:1000 epinephrine subcutaneously. If bronchospasm
predominates, 0.25 to 0.50 grams of intravenous aminophylline should
be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids,
even if given intravenously, exert no significant effect on the acute
allergic reactions for a few hours. The administration of these agents
should not be regarded as emergency measures for the treatment of
allergic reactions. Apprehensive patients may develop weakness, pallor,
tinnitus, diaphoresis and bradycardia following the administration
of any diagnostic agent. Such reactions are usually non-allergic in
nature and are best treated by having the patient lie flat for an
additional 10 to 30 minutes under observation.

Overdosage:

On rare occasions following repeated administration,
severe stomach cramps, nausea, vomiting, diarrhea or constipation
may occur. These indicated responses can be present in both fluoroscopic
and CT procedures. These are transitory in nature and are not considered
serious. Symptoms may be treated according to currently accepted standards
of medical care.

Dosage And Administration:

The volume
of the CT barium sulfate suspension to be administered will depend
on the degree and extent of contrast required in the area(s) under
examination and on the technique employed.

For Oral Administration: Gi Tract Marking:

The patient should begin drinking NeuLumEX
approximately 20 – 30 minutes prior to the scheduled procedure. It
is recommended that the patient consume multiple bottles, about 900
mL to 1,350 mL total volume prior to the exam or use as directed by
physician. For improved gastric marking have patient consume the final
200 mL immediately prior to scan. Bowel marking is consistent due
to the uniformity of the 0.1% concentration of BaSO4. Bowel lumen marking can be improved by increasing the volume of
NeuLumEX consumed (see below). Other dosing regimens may be followed
as applicable. In patients where marking is problematic, such as obesity
and delayed transit, improved marking may be possible by increasing
the total volume of NeuLumEX administered up to 1,800 mL or four (4)
bottles.

Storage:

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

How Supplied:

NeuLumEX is supplied in the following quantity: 450 mL bottles, Cat.
No. 9260, NDC 32909-926-03Rx OnlySHAKE WELL PRIOR TO USEManufactured
byE-Z-EM Canada Incfor Bracco Diagnostics
Inc.Monroe Township, NJ 08831Tel: 1-516-333-8230
1-800-544-4624 rev.
09/19 CL108901

* Please review the disclaimer below.