E-Z Paque: Package Insert / Prescribing Info

E-Z Paque Description

LIQUID E-Z-PAQUE® is a barium sulfate suspension (60% w/v, 41% w/w) for oral administration. Each 100 mL contains 60 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.

E-Z Paque - 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 E-Z Paque

For radiographic visualization of the gastrointestinal tract.

Contraindications

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

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.

Precautions

Adverse Reactions/Side Effects

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. 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 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.

E-Z Paque Dosage and Administration

The volume and concentration of LIQUID E-Z-PAQUE® 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.

Use undiluted for single contrast filled stomach with small bowel follow-through (typical adult dose: 150 mL to 340 mL); routine small bowel (typical adult dose: 340 mL to 750 mL); follow through small bowel after double contrast upper GI study (typical adult dose: 340 mL to 750 mL).

Storage and Handling

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

SHAKE WELL PRIOR TO USE, THE PRODUCT MUST BE FULLY SUSPENDED.

How is E-Z Paque supplied

LIQUID E-Z-PAQUE® is supplied in the following quantities:
1900 mL jugs, Cat. No. L186, NDC 32909-186-01;
355 mL bottles, Cat. No. L196, NDC 32909-186-02.

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. 07/14 TX1736

LIQUID E-Z-PAQUE 355 mL
NDC: 32909-186-02

LIQUID E-Z-PAQUE 1900 mL
NDC: 32909-186-01