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E-Z-CAT DRY (E-Z-EM Canada Inc)

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POWDER, FOR SUSPENSION 50 POUCH in 1 BOX (32909-727-01) > 23 g in 1 POUCH Label Information

Complete E-Z-CAT DRY Information

  • DESCRIPTION

    E-Z-CAT® DRY Barium Sulfate For Suspension (2% w/w After Mixing) is for oral administration. Each 100 g contains 41 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:

    artificial candied sugar, citric acid, ethyl vanillin, natural and artificial orange flavor, polysorbate 80, saccharin sodium, simethicone, sodium carboxymethylcellulose, sodium carrageenan, sodium citrate, sorbitol 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 use in Computed Tomography of the GI 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

    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.

    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 impaired or unknown, proceed with caution. If this product is aspirated into the larynx, further administration should be immediately discontinued.

    Information For Patients:

    Before administration of this product patients should be instructed to:

    1. Inform their physician if they are pregnant.
    2. Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate or other contrast agents used in x-ray procedures (see PRECAUTIONS - General).
    3. 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, 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, 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 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

    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.


  • DOSAGE AND ADMINISTRATION

    This product should be used as directed by a physician. The volume and concentration of the CT barium sulfate suspension to be administered will depend on the degree and extent of concentration required in the area(s) under examination and on the equipment and technique employed.

    Instructions for Mixing:

    Add 450 mL water into a mixing container. Pour contents of the pouch into the container. Replace the cap, invert the container to mix the powder with water and shake vigorously for 20 seconds. Let mixture stand for 5 minutes. Reshake prior to use for 15 seconds.

    Yield:

    460 mL of a 2% w/w barium sulfate suspension.

    Suggested 30 Minute Barium Administration Protocol for Abdomen Studies:

    Administer 300 mL (10 fl oz) CT barium sulfate suspension 30 minutes before scan and 150 mL (5 fl oz) immediately prior to scan; or use as directed by physician.

    Suggested 90 Minute Barium Administration Protocol for Abdomen / Pelvis Studies:

    Administer 450 mL (15 fl oz) CT barium sulfate suspension 90 minutes before scan, another 300 mL (10 fl oz) 30 minutes before scan, and 150 mL (5 fl oz) immediately prior to scan; or use as directed by physician.


  • HOW SUPPLIED

    E-Z-CAT® DRY is supplied in the following quantities:
    50 x 23 g (0.8 oz) Pouches, Cat. No. 727, NDC 32909-727-01


  • STORAGE

    Store product at USP Controlled Room Temperature, 20 to 25°C (68 to 77°F).

    After reconstitution with water, product must be refrigerated and used within 48 hours. Discard any unused portion.


  • SPL UNCLASSIFIED SECTION

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

    rev. 03/14  TX1635-2


  • PRINCIPAL DISPLAY PANEL

    E-Z-CAT DRY
    BARIUM SULFATE FOR SUSPENSION (2% w/w After Mixing)

    NDC: 32909-727-01

    E-Z-Cat Dry - Unit

  • INGREDIENTS AND APPEARANCE
    E-Z-CAT DRY 
    barium sulfate powder, for suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-727
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BARIUM SULFATE (UNII: 25BB7EKE2E) (BARIUM SULFATE - UNII:25BB7EKE2E) BARIUM SULFATE 9.5 g  in 23 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32909-727-01 50 in 1 BOX 01/01/1996 06/01/2019
    1 23 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/1996 06/01/2019
    Labeler - E-Z-EM Canada Inc (204211163)
    Registrant - E-Z-EM Canada Inc (204211163)
    Establishment
    Name Address ID/FEI Business Operations
    E-Z-EM Canada Inc 204211163 ANALYSIS(32909-727) , MANUFACTURE(32909-727) , LABEL(32909-727) , PACK(32909-727)
    Establishment
    Name Address ID/FEI Business Operations
    CIMBAR PERFORMANCE MINERALS, INC. 963805671 API MANUFACTURE(32909-727)