NDC 32909-167 Liquid Polibar Plus

Barium Sulfate

NDC Product Code 32909-167

NDC 32909-167-55

Package Description: 750 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Liquid Polibar Plus with NDC 32909-167 is a a human prescription drug product labeled by E-z-em Canada Inc. The generic name of Liquid Polibar Plus is barium sulfate. The product's dosage form is suspension and is administered via oral; rectal 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.

Liquid Polibar Plus 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 1.05 g/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.
  • Rectal - Administration to the rectum.

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: 02-01-2021 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: 12-31-2022 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.

Liquid Polibar Plus Product Label Images

Liquid Polibar Plus 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

LIQUID POLIBAR PLUS® Barium Sulfate Suspension (105% w/v, 58% w/w) is
a barium sulfate suspension for oral and rectal administration. Each
100 mL contains 105 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

Acacia, citric acid, hydrochloric
acid, natural and artificial vanilla flavor, polysorbate 80, potassium
chloride, potassium sorbate, purified water, saccharin sodium, simethicone
emulsion, sodium benzoate, sodium carrageenan, sodium citrate, sorbitol
solution and xanthan gum.

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
unchanged from the body.

Indications And Usage

For radiography of the gastrointestinal
tract.

Oral Administration

This product should not be used
in patients with known gastric or intestinal perforation or hypersensitivity
to barium sulfate products.

Use with caution in patient with
complete or nearly complete obstruction of the gastrointestinal tract.

Rectal Administration

This product should not be used
in patients with known intestinal perforation or hypersensitivity
to barium sulfate products.

Use with caution when obstructive
lesions of the colon are suspected. Care should be taken to minimize
the amount of barium sulfate allowed to flow proximal to obstructive
lesions of the colon. When used rectally, care must be taken during
insertion of the enema tip into the patient, since forceful or too
deep insertion may cause tearing or perforation of the rectum.

In order to assure rapid colonic
filling and drainage, LIQUID POLIBAR PLUS® should only be used with an enema kit with a large (½ inch) lumen
such as the Super XL® Enema Bag System
(Cat. No. 8925) or equivalent. Refer to the enema kit labeling for
additional CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and INSTRUCTIONS
FOR USE. Refer to manufacturer’s instructions if another administration
system is used.

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 this product 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 this product
is aspirated into the larynx, further administration should be immediately
discontinued.After any
barium study of the GI tract, it is important to rehydrate the patient
as quickly as possible to prevent impaction of the bowel by barium
sulfate. To prevent barium sulfate impaction in the bowel, the use
of mild laxatives such as milk of magnesia or lactulose, following
completion of the examination may also be required. These mild laxatives
are recommended on a routine basis and in patients with a history
of constipation unless contraindicated.

The volume and concentration of
LIQUID POLIBAR PLUS® to be administered
will depend on the degree and extent of contrast required in the area(s)
under examination and on the equipment and technique employed. See
applicable system below for typical adult dose.

Information For Patients

  • Before administration of this product patients
  • 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.

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, their 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, barium sulfate impaction,
granuloma formation, intravasation, embolization and peritonitis following
intestinal perforation, vasovagal and syncopal episodes, and fatalities.
EKG changes have been reported following or during barium enema procedures.
It is of the utmost importance to be completely prepared to treat
any such occurrence.

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,
must 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 mL 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.All E-Z-EM barium contrast and
barium contrast delivery systems are latex-free. However, allergic
reactions to enema accessories, in particular to retention catheters
(tips) with latex cuffs, can occur. Such reactions could occur immediately
and result in the previously mentioned acute allergic-like responses
or might be delayed in appearance and result in a contact dermatitis.
Known atopic patients, particularly those with a history of asthma
or eczema, should be evaluated for alternative methods of administration
in order to avoid these adverse reactions. All plastic/rubber accessories
are disposable, single-use devices that must not be reused or left
in the body cavity for an extended period of time.

Overdosage

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

Patient Preparation For Colon Examinations

In order to achieve optimum results, the colon
must be cleansed prior to the use of a barium enema. This is usually
accomplished by placing the patient on a low fat, low residue diet,
combined with the use of laxatives and/or cathartics. A cleansing
enema may also be used unless contraindicated.

Single Contrast Colon Studies

Dilute
1 part LIQUID POLIBAR PLUS® with 5 parts
water to yield approximately 17.5% w/v, 15% w/w; or dilute as required.Typical Adult Dose: 1000 mL to 2500 mL of diluted suspension.

Double Contrast Colon Studies

Use
undiluted.Typical Adult Dose: 500 mL to 1500
mL or as directed by a physician.

Esophagus And Cardiac Series

Undiluted
LIQUID POLIBAR PLUS® should be administered
orally for double-contrast examination of the esophagus. Films are
taken during rapid swallowing of barium sulfate.Typical Adult Dose: 60 mL to 300 mL

Stomach

LIQUID POLIBAR PLUS® can be used for single or double-contrast examination
of the stomach. It can be used undiluted or diluted 1:1 with water
to produce a 52.5% w/v. Diluted LIQUID POLIBAR PLUS® is highly suited for a biphasic examination of the stomach. Following
completion of the double-contrast examination of the stomach using
E-Z-HD™ barium sulfate, undiluted or diluted 1:1 with water, LIQUID
POLIBAR PLUS® may be used for the single
phase of the study.Typical Adult Dose: 150
mL to 340 mL of diluted or undiluted as applicable.

Small Bowel Series

LIQUID POLIBAR PLUS® can be used for small bowel series. It can be given
alone or can be used following the completion of a double-contrast
examination of the stomach using E-Z-HD™. It may be given either undiluted
or in 1:1 dilution. Higher dilution will decrease the density of the
barium sulfate but will increase the speed of the flow of contrast.Typical Adult Dose: 340 mL to 750 mL of diluted or
undiluted as applicable.

Storage

USP Controlled Room Temperature,
20 to 25°C (68 to 77°F). Protect from freezing.

How Supplied

LIQUID POLIBAR PLUS® is supplied as follows:1900 mL jugs,
Cat. No. L168, NDC 32909-168-02.Rx Only (USA)SHAKE WELL PRIOR TO USE

* Please review the disclaimer below.