You are here: Home > Prescription(RX) Drugs > E > Enhancer (Mallinckrodt Inc.)|
barium sulfate for suspension
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.
BARIUM SULFATE FOR SUSPENSION
DESCRIPTIONEnhancer is a lemon-vanilla flavored, high density barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations.
The product contains 98% w/w barium sulfate USP, sucrose, simethicone, suspending agents, sorbitol, flavoring, sodium citrate and saccharin sodium. Barium sulfate has the empirical formula of BaSO4.
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
Enhancer 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.
GeneralDiagnostic 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 double contrast examinations in which glucagon has been used.
Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.
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.
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 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 Enhancer’s 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.
Mixing Directions• Fill the water measuring cup supplied with Enhancer to overflow (approximately 68 mL) and add to the contents of the bottle.
• Secure the bottle cap, invert and shake vigorously for 5 seconds in an up and down motion.
• Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds.
• Just prior to patient administration remix to assure suspension uniformity.
The Enhancer unit dose bottle prepares approximately 135 mL of 225% w/v high density barium sulfate suspension. Use within 6 hours of preparation.
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 Enhancer suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate).
HOW SUPPLIEDCatalog No. 149811. NDC 68240-527-11. 312 gm bottle; thirty-six (36) bottles with straws and one (1) water measuring cup per case.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Enhancer is a trademark of Lafayette Pharmaceuticals, Incorporated.
Distributed in Canada by:
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A
Made in Mexico
St. Louis, MO 63042 USA
Package Label - Principal Display Panel - 312 gm Bottle
L A F A Y E T T EENHANCER™
DOUBLE CONTRAST /
Catalog No. 149811
A lemon-vanilla 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, sucrose, simethicone, suspending agents, sorbitol, flavoring, sodium citrate and saccharin sodium.
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: 08/2010 Mallinckrodt Inc.
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2017
|Over-the-counter (OTC) Drugs|