Prepcat Suspension

Name: Prepcat Suspension

Prepcat Suspension - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Prepcat Suspension

Prepcat is indicated for use as a diagnostic aid (contrast medium) for computed tomography of the gastrointestinal tract.

Prepcat Suspension Dosage and Administration

Individual technique will determine the suspension quantity and specific procedure used. The following are suggested for Prepcat use as an aid for computed tomography.

Upper G.I. Opacification

The patient should drink 300 mL of ready-to-use Prepcat approximately 2 hours before the CT scan and an additional 300 mL approximately 15 minutes prior to examination.

If rapid upper gastrointestinal tract transit is desired, administer the product chilled.

Total Bowel Opacification

The patient should drink 300 mL the night preceding the examination, 300 mL two hours prior to the examination and 300 mL approximately 15 minutes prior to examination.

Rectal/Colon Administration

Rectally administered Prepcat should be at room temperature to body temperature. Transfer the desired quantity of ready-to-use Prepcat into an enema administration unit, such as Empty Enema Kit. Close the slide clamp. Lubricate the tip and carefully insert. If Empty Enema Kit is used, invert and squeeze the red ball into the bag. Return the bag to upright and with the patient in the left lateral position, open the slide clamp to administer the suspension. Coating of the entire colon may be achieved by rotating the patient 360°. For increased patient comfort, excess suspension may be drained back into the enema bag.

Pediatric Use

The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.

For single patient use only. Properly discard unused portion.

How is Prepcat Suspension Supplied

Catalog No. 169415. NDC 68240-126-45. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.

Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59 to 86ºF). Protect from freezing.

Shake well before using.


DIN: 00794260
Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A

Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com

MID 1304678    Rev 04/2009

CT CONTRAST
G.I. EXAMS
  • Pre-mixed
  • Ready-to-use
  • Flavored

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 450 mL Bottle

L A F A Y E T T E

PREPCAT™
BARIUM SULFATE SUSPENSION

Catalog No. 169415

O3™ ANTIMICROBIAL TECHNOLOGY

CT CONTRAST / G.I. EXAMS

Rx only

450 mL

PREPCAT
Barium Sulfate Suspension USP

NDC 68240-126-45
Catalog No. 169415

A strawberry flavored, ready-to-use, 1.5% w/w (w/v), barium sulfate USP suspension for use as an aid for computed tomography of the gastrointestinal tract.

Contents: Barium sulfate USP, sorbitol, simethicone, suspending agent, potassium sorbate, flavoring, citric acid, saccharin sodium and water.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions.

For single patient use only. Properly discard unused portion.

Shake well before using.

Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.

Net Contents: 450 mL (15 fl. oz.)

DIN: 00794260
Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A

Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com

MID 1170010
Rev 04/2009

tyco
Healthcare

Mallinckrodt

PREPCAT 
barium sulfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-126
Route of Administration ORAL, RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE 150 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SODIUM HYPOCHLORITE  
POTASSIUM SORBATE  
HYDROGEN PEROXIDE  
SORBITOL  
CITRIC ACID MONOHYDRATE  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:68240-126-45 24 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 450 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 12/01/2009
Labeler - Mallinckrodt Inc. (810407189)
Establishment
Name Address ID/FEI Operations
Mallinckrodt Medical, S.A. de C.V. 810407189 analysis, manufacture
Revised: 06/2009   Mallinckrodt Inc.
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