BARICON
-
barium sulfate for suspension
Mallinckrodt Inc.
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LAFAYETTEBARICON™
BARIUM SULFATE FOR SUSPENSION
Rx only
DESCRIPTION
Baricon is a lemon-vanilla flavored, high density barium sulfate formulation for aqueous suspension and use as a contrast medium in double 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.
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. Excretion rate is a function of gastrointestinal transit time.
INDICATIONS AND USAGE
Baricon is indicated for use as a contrast medium in double contrast stomach examinations.
CONTRAINDICATIONS
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.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.
Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. 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. Aspiration of smaller amounts may cause inflammation.
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.
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 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 examination 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.
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. It is of the utmost importance to be completely prepared to treat any such occurrence.Due to 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.
Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have 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.
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.
OVERDOSAGE
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 the suspension quantity, concentration, and specific procedure used. The following are suggested for Baricon use in double contrast stomach examinations.Patient Preparation
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 Tube to overflow (approximately 74 mL) and add to the contents of the bottle.• Secure the bottle cap, invert and shake vigorously for 10 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.
• Use within 6 hours of preparation. Discard unused portion.
The Baricon unit dose bottle prepares approximately 145 mL of 230% w/v high density barium sulfate suspension. Use within 6 hours of preparation. Discard unused suspension.
ADMINISTRATION
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 Baricon suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate).
For single patient use only. Properly discard unused portion.
HOW SUPPLIED
Catalog No. 149112. NDC 68240-628-12. 340 gm unit dose bottle; thirty-six (36) bottles and two (2) Water Measuring Tubes per case.
Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).
Baricon is a trademark of Lafayette Pharmaceuticals, Incorporated.
DIN: 00390909
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 1304671
Rev 04/2009
UPPER G.I.
- Unit dose
- High density
- Low viscosity
tyco
Healthcare
Mallinckrodt
Package Label - Principal Display Panel - 340 gm Bottle
L A F A Y E T T E
BARICON™
BARIUM SULFATE
FOR SUSPENSION
Catalog No. 149112
DOUBLE CONTRAST / UPPER G.I.
Rx only
340 gm
BARICON
Barium Sulfate for Suspension
NDC 68240-628-12
Catalog No. 149112
A lemon-vanilla flavored 98% w/w barium sulfate formulation for aqueous suspension and use 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.
Mixing Directions:
- Fill the Baricon Water Measuring Tube to overflow (74 mL) and add to the contents of the bottle. Secure the bottle cap.
- Invert and shake vigorously for 10 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.
- Use within 6 hours of preparation.
For single patient use only. Properly discard unused portion.
This bottle prepares approximately 145 mL of 230% w/v high density barium sulfate suspension.
Storage: Store at 25ºC (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Net Contents: 340 gm
Rev 04/2009
DIN: 00390909
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
tyco
Healthcare
Mallinckrodt
| BARICON
barium sulfate for suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 12/01/2009 | 04/30/2011 | |
| Labeler - Mallinckrodt Inc. (810407189) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mallinckrodt Medical, S.A. de C.V. | 810407189 | analysis, manufacture | |