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.
LIQUID (Target Viscosity 4 CPS) is a barium sulfate for suspension
(40% w/v After Reconstitution) for oral administration. Each 100 g
contains 81 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: carboxymethylcellulose sodium,
citric acid, maltodextrin, natural and artificial apple flavor, polysorbate
80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol.
Indications And Usage
product is indicated for use in radiography of the esophagus, pharynx
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.
should not be used in patients with known or suspected gastrointestinal
perforation; or hypersensitivity to barium sulfate or any components
of this barium sulfate formulation.
Rarely, severe allergic reactions of an anaphylactoid
nature, have been reported following administration of barium sulfate
contrast agents. Appropriate facilities and trained personnel 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.
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.Given that the contrast material is designed
for a procedure that is performed to document the presence and extent
of pathophysiology of the swallowing mechanism as well as to determine
appropriate remediation of such, aspiration of the barium sulfate
is an expected consequence for some patients. When this occurs, it
is recommended that the patient be assisted in attempts to expectorate
the aspirant. The study should be resumed if the clinician is prepared
to assess the patient’s response to specific interventions designed
to eliminate or minimize the recurrence of aspiration (postural changes,
sensory enhancements, swallowing maneuvers and/or dietary changes).
It is recommended that the study begin with the introduction of limited
amounts of material per swallow (3 mL or less).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, secondary to administration of large volumes
of this product (i.e. >120 mL) the use of mild laxatives such as milk
of magnesia or lactulose, following completion of the examination
may also be required.Use with caution in patients with complete or nearly complete esophageal
or gastric obstruction.
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.
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.
products may be used during lactation.
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
impaction, granuloma formation, intravasation, embolization and peritonitis
following intestinal perforation, vasovagal and syncopal episodes,
and fatalities. It is of the utmost importance to be completely prepared
to treat any such occurrence.
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.
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.
Mixing Instructions for VARIBAR® THIN LIQUID Cat. No. D105: Add water to the 40% w/v line on the VARIBAR® THIN LIQUID bottle
label and replace the lid securely. Invert the bottle and tap with
fingers to mix the powder into the water. Shake vigorously for 30
seconds. Wait 5 minutes, and refill with water to the 40% w/v line.
Then reshake thoroughly.After reconstitution with water, VARIBAR® THIN LIQUID has been shown
to be stable for up to 72 hours if refrigerated at 2°-8° C. With refrigeration,
notate the information on the label to track usage time. Enter date
opened and use by date.
instructions for reconstituting Varibar® Thin Liquid (Cat # D105)
Dosage And Administration
The dose of VARIBAR® THIN LIQUID 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.
Store VARIBAR® THIN LIQUID to protect from freezing
and excessive heat (above 40°C).
VARIBAR® THIN LIQUID is supplied in the following
quantity: 148 g bottle, Cat. No. D105, NDC 32909-105-10Manufactured byE-Z-EM Canada
Inc., for E-Z-EM, Inc.a subsidiary of Bracco Diagnostics
Inc.Monroe Township, NJ 08831Tel: 1-516-333-8230
1-800 544-4624rev. 05/14 TX1356-3
* Please review the disclaimer below.