Anatrast Paste

Anatrast is indicated for use in defecography.

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.

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.

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.

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.

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