Anatrast Paste

Generic Name: barium sulfate
Dosage Form: paste

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

LAFAYETTE
ANATRAST™
BARIUM SULFATE PASTE

Rx only

Anatrast Paste Description

Anatrast is a cherry flavored, ready-to-use barium sulfate USP suspension paste. It is a contrast medium developed for defecography.

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The product contains 100% w/v (56% w/w) barium sulfate USP, sorbitol, suspending and dispersing agents, simethicone, flavoring, preservatives and water. Barium sulfate has the empirical formula BaSO4.

Anatrast Paste - 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.

Indications and Usage for Anatrast Paste

Anatrast is indicated for use in defecography.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex.

The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

In patients with increased intracranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.

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, a family history of allergy, 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.

Anaphylactic and allergic reactions have been reported during barium sulfate suspension examinations in which glucagon has been used.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.

Because of reported anaphylactoid reactions to latex, the use of vinyl gloves during the procedure should be considered.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) 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. EKG changes have been shown to occur following or during barium sulfate suspension enemas. 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, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.

Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has been reported.

A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.

Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.

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.

Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, nausea, procedural site reactions, rash and vomiting.

Anatrast Paste Dosage and Administration

Cut off approximately 1/2" from the end of the Anatrast cartridge nozzle. Place the flange end of the rectal tip unit on the cartridge. Be sure that the tip flange is flush with the body of the cartridge. Insert the cartridge into the administration unit. Position the cartridge so that the tip flange is held in place behind the metal flange of the administration unit.

The following technique is suggested for media administration. Individual technique will determine the quantity of media and procedure to be used. Place the patient in the left lateral position on a gurney or x-ray table. Use a lubricated gloved finger to gently determine the anal tone and canal orientation. Lubricate the tip and gently insert into the patient. Do not insert further than the black mark on the rectal tip unit (approximately 3 ¼ inches).

Slowly administer Anatrast into the rectum under fluoroscopic guidance. The patient should be instructed to inform the radiologist if there is any urge to defecate or a feeling of urgency or pain. Proceed with filling until either (1) the patient complains of the urge to defecate, (2) the sigmoid, as well as the rectum, begins to fill, or (3) the entire contents of the Anatrast cartridge have been used. Remove the tip while maintaining gentle pressure on the administration unit trigger. Discard the cartridge and tip after use.

Seat the patient on the defecography chair and proceed with the examination.

For single patient use only. Properly discard unused portion.

How is Anatrast Paste Supplied

Catalog No. 151118. NDC 68240-326-12. 500 gm tubes. Twelve (12) tubes and twelve (12) enema tip assemblies per case.

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

Anatrast is a trademark of Mallinckrodt Inc.

DIN: 00783145
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 1304647 Rev 03/2009

DEFECOGRAPHY
G.I. EXAMS

  • High viscosity
  • Ready-to-use

tyco
Healthcare

MALLINCKRODT

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 500 gm tube

LAFAYETTE
ANATRAST
Barium Sulfate Paste
Catalog No. 151118

O3 ANTIMICROBIAL TECHNOLOGY

DEFECOGRAPHY / LOWER G.I. EXAMS

Rx only

500 gm

ANATRAST
Barium Sulfate Paste USP
NDC
68240-326-12

Catalog No. 151118

A cherry flavored, ready-to-use, 100% w/v (56% w/w) barium sulfate suspension
paste for use as a diagnostic aid for defecography.

Contents: Barium sulfate USP, sorbitol, suspending and dispersing agents, simethicone, flavoring, preservatives 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.

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

Contains: 500 gm

DIN: 00783145
Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A

MID 1170090 Rev 03/2009

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

tyco/Healthcare

MALLINCKRODT

ANATRAST 
barium sulfate paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-326
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE 560 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM HYPOCHLORITE  
WATER  
SORBITOL  
CROSCARMELLOSE SODIUM  
METHYLPARABEN  
PROPYLPARABEN  
METHYL SALICYLATE  
BENTONITE  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (CHERRY) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68240-326-12 12 TUBE (30 TUBE) in 1 CASE
1 500 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 10/31/2011
Labeler - Mallinckrodt Inc. (810407189)
Establishment
Name Address ID/FEI Operations
Mallinckrodt Medical, S.A. de C.V. 810407189 manufacture, analysis
Revised: 08/2010
 
Mallinckrodt Inc.
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