FDA Label for Varibar Thin Liquid

Description

VARIBAR^® THIN 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

This product is indicated for use in radiography of the esophagus, pharynx and hypopharynx.

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.

Contraindications

This product 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.

Warnings

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.

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.

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.

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 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.

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.

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.

Other

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.

Mixing 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.

Storage

Store VARIBAR® THIN LIQUID to protect from freezing and excessive heat (above 40°C).

How Supplied

VARIBAR® THIN LIQUID is supplied in the following quantity: 148 g bottle, Cat. No. D105, NDC 32909-105-10

Manufactured by
E-Z-EM Canada Inc., for E-Z-EM, Inc.
a subsidiary of Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Tel: 1-516-333-8230 1-800 544-4624

rev. 05/14 TX1356-3

Package Label.Principal Display Panel

Varibar^® Thin Liquid - Barium Sulfate for Suspension
CAT. NO.: D105
NDC: 32909-105-10