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barium sulfate paste
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BARIUM SULFATE PASTE
Intropaste is a raspberry flavored, ready-to-use barium sulfate USP suspension paste for use as a contrast medium in x-ray examination of the esophagus.
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
Intropaste is indicated for use as a contrast medium during x-ray examination of the esophagus.
Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.
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.
Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.
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.
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.
The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.
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. It is of the utmost importance to be completely prepared to treat any such occurrence.
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.
In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.
DOSAGE AND ADMINISTRATION
Individual technique will determine paste quantity and specific procedure used. Optimum coating is usually obtained with 2 to 3 teaspoonfuls of Intropaste.
Catalog No. 152116. NDC 68240-022-12. 454 gm tubes. Twelve (12) tubes per case.
Package Label - Principal Display Panel - 454 gm Tube
L A F A Y E T T EINTROPASTE™
BARIUM SULFATE PASTE
O3™ ANTIMICROBIAL TECHNOLOGY
A raspberry flavored 70% w/v (44% w/w) barium sulfate USP suspension paste for use as a contrast medium in x-ray examination of the esophagus.
Contents: Barium sulfate USP, sorbitol, suspending and dispersing agents, simethicone, flavoring, methylparaben and propylparaben (preservatives), saccharin sodium (artificial sweetener) and water.
Contraindications: Do not use in patients with known or suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.
Dosage and Administration: See package insert for complete instructions.
Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.
Net Contents: 454 grams
Made in Mexico
Revised: 08/2010 Mallinckrodt Inc.
Reproduced with permission of U.S. National Library of Medicine
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