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HD 200 PLUS
barium sulfate for suspension
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HD 200™ PLUS
BARIUM SULFATE FOR SUSPENSION
HD 200 PLUS is a strawberry flavored, high density barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations.
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
HD 200 PLUS is indicated for use as a contrast medium in double contrast stomach examinations.
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, 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.
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 may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of a 115% w/v barium sulfate suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.
DOSAGE AND ADMINISTRATION
Individual technique will determine the suspension quantity, concentration, and specific procedure used. The following are suggested for HD 200 PLUS use in double contrast stomach examinations.
Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations, done separately or combined with an upper gastrointestinal series, is the same.
• Fill the water measuring cup supplied with HD 200 PLUS to overflow (approximately 68 mL) and add to the contents of the bottle.
While techniques may vary, it is suggested that the patient place a gas producing agent such as sodium bicarbonate on the tongue and wash down with 10 mL of water. Immediately following the sodium bicarbonate and while the patient is in the upright position, have the patient drink the HD 200 PLUS suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate).
Catalog No. 149311. NDC 68240-128-08. 312 gm bottle; thirty-six (36) bottles with straws and one (1) water measuring cup per case.
Package Label - Principal Display Panel - 312 gm Bottle
L A F A Y E T T EHD 200™ PLUS
Catalog No. 149311
DOUBLE CONTRAST /
HD 200 PLUS
A strawberry flavored, high density, 98% w/w barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations.
Contents: Barium sulfate USP, suspending agents, sucrose, saccharin sodium, simethicone and artificial flavoring.
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.
This bottle prepares approximately 135 mL of 225% w/v high density barium sulfate suspension.
Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Net Contents: 312 gm
Made in Mexico
Revised: 11/2010 Mallinckrodt Inc.
Reproduced with permission of U.S. National Library of Medicine
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